Search results from the Australian New Zealand Clinical Trials Registry

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Keyword: cannabinoid
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ACTNSWNTQLDSATASVICWA

A study to evaluate the safety, tolerability, and pharmacokinetics of a medicinal cannabinoid oil formulation in chronic non-cancer pain participants on long term opioid treatments

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Trial Information

Trial summary

There is some evidence that cannabinoids may enable patients to reduce their opioid medication whilst maintaining adequate analgesia - known as opioid sparing.  If so, cannabinoids could prove effective in reducing drop-out rates in opioid dose taper regimen, assisting patients with poorly managed pain.  

This protocol is a preliminary dose escalation pharmacokinetic study which will evaluate the safety and tolerability of a cannabinoid (THC:CBD) oil formulation following a single dose and following repeated dosing in patients with chronic non-cancer pain. The data from this pharmacokinetic study will inform a subsequent trial which will assess the impact of oral CBD/THC combination oil on patient ability to tolerate a stepped opioid tapering protocol at a rate of 10% per week over 10 weeks.

Broad Health Conditionchronic pain

Specific Health ConditionAnaesthesiology
Pain management

Trial FocusTreatment

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
VIC

Hospital
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Postcode
3065 - Fitzroy

Anticipated date of first participant enrolment15/07/2019

Anticipated date of last participant enrolment30/08/2019

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Chronic non-cancer pain on long term treatment (>12months) with high dose (OMEDD >60mg) opioid analgesia.
Willing to cease driving a motor vehicle for the duration of the study.
No cannabis use in the last month.

Minimum age25 Years

Maximum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Dependence on cannabis.
Cardiovascular disorder, epilepsy, psychosis, bipolar disorder, 1st degree relative with psychosis.
Dependence on alcohol, benzodiazepines, or amphetamine type stimulants.
Evidence of severe hepatic/renal impairment.
Active malignancy.
Females who are pregnant, lactating or not using adequate contraception.
Males who are not using adequate contraception.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Zelda Therapeutics
Primary Sponsor Address: Level 26, 140 St Georges Terrace Perth WA 6000
Primary Sponsor Country: Australia

Trial IDACTRN12619001013156

UTNU1111-1236-0524

Contact person for information and recruitmentMs
Amanda Norman
Department of Addiction Medicine St Vincent's Hospital Melbourne PO Box 2900 Fitzroy VIC 3065
+61-03-92312627

Further information iconamand.norman@svha.org.au
Australia

A single-dose, double-blind, placebo-controlled, randomised, crossover study of an oral cannabis-based medicine (ETC120) on sleep, cognition, and next-day function in adults with primary insomnia disorder

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Trial Information

Trial summary

Anecdotally, cannabis is frequently reported by consumers to promote sleep. Indeed, a recent Australian survey found that sleep disorders were the fourth most indicated reason for using cannabis for medicinal reasons in a community sample of 1,700 users (Lintzeris et al., 2018). While improved sleep is one of the positive effects that cannabis users typically report, there is limited well-designed research using objective measures assessing the effects of cannabis on sleep quality and quantity. Moreover, no study to-date has examined the effects of cannabinoid medicine in people with primary insomnia disorder.  

To address this gap, we will investigate the acute effects of a cannabinoid medicine (ETC120) on sleep and next-day function compared to placebo in patients with primary insomnia disorder. This study will utilise novel high-density 256-channel EEG coupled with structural MRI to examine and localise differences in sleep depth and brain activation during both sleep and wakefulness following a single dose of ETC120 and placebo during an overnight sleep study. Daytime function including cognition, alertness and driving performance will also be assessed. 

As this is a pilot study, we aim to recruit 20 patients aged 35-60 years inclusive with a diagnosis of primary insomnia disorder. Participants will be comprehensively screened for eligibility across 1-2 visits at the Woolcock Institute of Medical Research, Sydney. All participants will receive all of the interventions in a randomised and counterbalanced order during two overnight sleep studies at the sleep laboratory at the Woolcock Institute of Medical Research. Each overnight sleep study will take approximately 24 hours to complete and will be scheduled at least one-week apart to avoid any carryover effects. 
 
This aim of this study is to provide high-quality pilot data using novel multimodal neuroimaging technologies to comprehensively examine the acute effects of a cannabinoid medicine on sleep in patients with primary insomnia disorder. 

Broad Health ConditionInsomnia

Specific Health ConditionNeurological
Other neurological disorders

Trial FocusTreatment

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
NSW

Hospital
Woolcock Institute of Medical Research - Glebe

Postcode
2037 - Glebe

Anticipated date of first participant enrolment1/06/2019

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Males and females aged 35 – 60 years old,
2. Primary insomnia disorder diagnosed by a sleep physician or psychologist,
3. Insomnia Severity Index (ISI) score greater than or equal to 15,
4. Insomnia symptoms for more than 3 times per week and present for longer than 3 months,
5. Proficiency in English, and capable and willing to provide informed consent to the study procedures. 

Minimum age35 Years

Maximum age60 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Medical condition or medication that is the cause of the insomnia;
2.	Known hypersensitivity to cannabinoids;
3.	No reported use of cannabis within the past 3 months (or at the medical officer’s discretion) and confirmed by at least one negative urine drug screen (UDS);
4.	Past or present history of cannabis dependence (ICD-10 criteria or at the medical officer’s discretion);
5.	Sleep apnea (defined as Apnea Hypopnea Index [AHI] >15 and Oxygen Desaturation Index [ODI]>10) or sleep-related movement disorder based on in-laboratory polysomnography;
6.	Delayed sleep phase syndrome (determined on clinical interview, actigraphy and sleep diary at screening);
7.	Any medical condition related to an abnormal EEG (i.e. epilepsy, brain injury);
8.	Shift-work, transmeridian travel (2 time zones) over the last one month;
9.	History of major psychiatric disorder in the past 12 months except clinically-managed mild depression;
10.	History of suicide attempt or current suicide ideation (score greater than 0 on Q9 to PHQ-9 at screening); 
11.	Current evidence of clinically significant disease [including participants who lack capacity and/or whose cognitive decline indicates disorientation to person/place/time and/or situation], or malignancy or chronic pain that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments;
12.	Clinically relevant cardiovascular abnormalities as determined by 12-lead electrocardiogram (ECG) at screening;
13.	Pregnancy or lactation - males and females shall be advised to use reliable contraception for the duration of drug therapy and a urine pregnancy test will be performed for female participants where necessary;
14.	Use of any CNS-active drugs (including antidepressants, opioids, benzodiazepines) for the past 3 months or at the medical officer’s discretion; 
15.	Use of medications that may have a clinically significant impact upon the metabolism and excretion of cannabinoids at the medical officer’s discretion (e.g. CYP450 enzyme inducers/inhibitors);
16.	History of drug or alcohol dependency or abuse within approximately the past 2 years;
17.	Urinary drug test positive for drugs (cannabis, amphetamines, and cocaine) at screening visit;
18.	Excessive caffeine use that in the opinion of the investigator contributes to the participant's insomnia, or if participant is unable to abstain from caffeine use 24 hours prior to and during each overnight sleep study;
19.	Inability to refrain from alcohol consumption 24 hours prior to and during each overnight sleep study; 
20.	Individuals who regularly smoke or at the medical officer’s discretion;
21.	Medical conditions that result in frequent need to get out of bed (e.g. nocturia);
22.	Used any modality of treatment for insomnia, including CBT within 2 weeks before screening;
23.	Unable to undergo MRI brain imaging due to implanted device (e.g. defibrillator, pacemaker) as identified via MRI screening questionnaire;  
24.	Required to complete mandatory drug testing (e.g. workplace testing, court order).

Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Woolcock Institute of Medical Research
Primary Sponsor Address: 431 Glebe point Road, 2037, NSW, Glebe
Primary Sponsor Country: Australia

Trial IDACTRN12619000714189

UTNU1111-1231-0849

Contact person for information and recruitmentMiss
Anastasia Suraev
Woolcock Institute of Medical Research, 431 Glebe point Road, 2037, NSW, Glebe
+61 2 9114 0452

Further information iconanastasia.suraev@sydney.edu.au
Australia

Cannabinoids for Symptom Control in Advanced Cancer, an Open Label Prospective Clinical Trial in New South Wales (NSW)

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Trial Information

Trial summary

The main purpose of this study is to determine what dose and frequency of medicinal cannabis is the best to relieve key symptoms in people with advanced cancer. 

Who is it for?
You may be eligible to join this study if you are aged 18 years or more, have a confirmed diagnosis of advanced cancer, with significant symptoms of severe pain, and/or vomiting, and/or nausea and/or lack of appetite that are poorly controlled by usual treatments, and a predicted life expectancy of more than 6 months and less than 12 months.

Study details
All participants in the study will be prescribed one of a number of cannabis medicines. The cannabis product will be given in addition to the usual treatments for their advanced cancer symptoms. On the first day of treatment participants will have 5 blood samples collected over 4 hours to measure the levels of cannabis medicines in their blood. They will also complete some online questionnaires about how they feel and be monitored for side effects.

Participants will remain enrolled in this trial and receive the cannabis medication prescribed at no cost until they are no longer able to take it or withdraw from the trial. Participants will be asked to complete regular online questionnaires and have a single blood sample taken every few weeks when they see the trial doctor, until they no longer receive the product and/or withdraw from the trial.

It is hoped the information collected in this study will guide the use of cannabis medicines to control symptoms in people with advanced cancer.

Broad Health ConditionCancer
Pain
Anorexia
Nausea

Specific Health ConditionCancer
Any cancer
Anaesthesiology
Pain management

Trial FocusTreatment

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
NSW

Anticipated date of first participant enrolment1/04/2019

Anticipated date of last participant enrolment1/04/2022

Phase of TrialPhase 4

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Aged 18 years or older.
2. Has provided written Informed Consent for participation in this trial.
3. Confirmed advanced cancer (any) with or without stable disease.
4. Predicted life expectancy of 6 to 12 months at time of consent, as estimated by the study investigator and confirmed by an additional qualified clinician, independent of the trial.
5. Persistent symptoms of anorexia, nausea or refractory pain, which in the investigator’s opinion are not responsive to implementation of standard practice, and who are ineligible or not wishing to be involved in other clinical trials of cannabis medicines. 
6. Willing and able, in investigator’s opinion, to comply with all trial requirements, including keeping a patient diary, completing clinical measurement scales and having pharmacokinetic samples collected as per Participant Information Sheet. Note: completion of these trial requirements is essential and intentional non-compliance may cease access to trial product and will be managed on a case-by-case basis. Non-compliance due to declining health is unintentional and it is hoped unintentional noncompliance due to declining health may be minimised through optional proxy completion of patient reported outcomes and patient diary.
7. Available to attend Trial Site for follow up and collection of investigational product.
8. Participants (and/or partners) capable of childbearing are using adequate contraception.

Participants are able to continue to receive standard concomitant care and interventions, such as chemotherapy and radiotherapy, and take medications for other conditions as usual in the advanced care population

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Lack of capacity to consent.
2. Unwilling to keep a Patient Diary, attend follow up appointments, complete clinical measurement scales or have pharmacokinetic samples. 
3. History of schizophrenia, other psychotic illness, severe borderline personality disorder, or other significant psychiatric disorder other than depression or anxiety associated with underlying condition. Delirium is an excluded condition.
4. Previous severe adverse event to any cannabinoid product, such as cannabis related psychosis, panic attack, palpitations.
5. A diagnosed substance use disorder (ICD-10 criteria (abuse, dependence)) to alcohol, opioids, cannabis, benzodiazepines, or illicit stimulants. Nicotine and caffeine are excluded. 
6. Known allergy to cannabis or other ingredient of cannabis medicine e.g. carrier oil.

Note: Prior access to authorised cannabis medicines or current use of illicit cannabis is not an exclusion, unless associated with a serious adverse event (SAE) or substance use disorder as per exclusion criteria above.
Contact details and further information

Sponsor Primary Sponsor Type: Government body
Primary Sponsor Name: Health Administration Corporation acting through the NSW Ministry of Health
Primary Sponsor Address: Medical Advisor Office of the Chief Health Officer, NSW Health 73 Miller Street North Sydney NSW 2060
Primary Sponsor Country: Australia

Trial IDACTRN12619000265178

UTNU1111-1227-1657

Contact person for information and recruitmentDr
Rachel Galettis
Clinical Trial Coordinator ACRE C/- Hunter Medical Research Institute Lot 1, Kookaburra Circuit, New Lambton Heights, NSW, 2305
+61 2 40420915

Further information iconACRE-CARE@newcastle.edu.au
Australia

A study that evaluates the effectiveness of oral combined THC/CBD for people with advanced cancer experiencing a range of symptoms.

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Trial Information

Trial summary

The purpose of this study is to assess whether delta-9-tetrahydrocannabinol (THC) and cannabidoil (CBD) can be used to reduce total symptoms in patients with advanced cancer in palliative care.

Who is it for?

You may be eligible for this study if you are over 25 years of age and have been diagnosed with advanced cancer.

Study details

Participants will be randomly assigned to one of two treatment groups; either THC/CBD or a placebo medication. 

Participants will be asked to take increasing doses of the study medication for 14 days, with the dose increasing until participants are satisfied with the symptom improvement and are experiencing no unacceptable side effects. After these 14 days, participants will be asked to take a steady dose of the medication for another set of 14 days. 

During the 28 days of the study you will be required to have routine bloods and urine test which will be used as part of the eligibility and post trial analysis 

It is hoped that this research will show a positive effect of THC/CBD on symptoms for patients suffering with advanced cancer and thus provide an option in helping manage symptoms.

Broad Health ConditionCancer
Fatigue
Nausea
Breathlessness
Appetite
Psychological effects

Specific Health ConditionCancer
Any cancer

Trial FocusTreatment

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
QLD

Hospital
Mater Adult Hospital - South Brisbane

Hospital
Mater Private Hospital - South Brisbane

Hospital
St Vincent's Hospital Brisbane - Kangaroo Point

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Gold Coast Hospital - Southport

Postcode
4101 - South Brisbane

Postcode
4169 - Kangaroo Point

Postcode
4029 - Herston

Postcode
4102 - Woolloongabba

Postcode
4215 - Southport

Anticipated date of first participant enrolment1/04/2019

Anticipated date of last participant enrolment1/04/2022

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patients with advanced histologically proven cancer (metastatic or locally advanced) known to the palliative care team of the recruiting centre who:

- have an ESAS TSDS greater than 10 for cancer-related symptoms*
- at least one individual ESAS score greater than 3
- AKPS score >30
- aged >25yrs and above. English speaking (or have interpreter available)
- have a negative pregnancy urine test at eligibility (only if of reproductive potential) and 
  agree to avoid pregnancy during the study and 12 weeks following the last dose of the 
  study drug. Males must agree to avoid fathering a child and to not donate sperm during 
  the study and for at least 12 weeks following the last dose of the study drug
- have a negative THC urine test
- able to tolerate oral medication 
- willing to receive standard palliative care
- comply with trial requirements; agree to attend scheduled clinic appointments, adhere to dose 
   titration schedule as directed
- agree to use no other cannabis based products for the duration of the trial
- understand it is illegal to drive whilst taking THC containing cannabis products, to take 
  cannabinoid products outside of Australia or to endorse legal documents whilst taking THC 
  containing cannabis products
- provide fully informed consent
*physician assessed

Minimum age25 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients with:

- a history of hypersensitivity to any cannabinoid product
- unstable untreated cardiovascular disease (hypertension, ischemic heart disease, congestive 
  cardiac failure)
- severe hepatic impairment (total bilirubin >1.5 times the upper limit of the institution's normal 
  range. Asparate aminotransferase (AST), and alanne aminotransferase (ALT) >3.0 time the upper 
  limit of the institution's normal range; subjects with liver metastasis may have an AST and ALT of 
  >5.0 times the upper limit of normal
- severe renal impairment (eGFR <20mls/min/1.73m2)
- history of psychiatric disorders (severe depression or anxiety, personality disorder, psychosis, 
  schizophrenia, first degree relative with schizophrenia and/or suicidal ideation)
- cognitive impairment (SLUMS - St Louis University Mental Status) examination <20/30
- known substance use disorder (ASSIST - Alcohol, Smoking and Substance Involvement Screening 
  Test) examination score >27+ 
- history that drug diversion may be a risk for them or their family/carers
- females who are pregnant or lactating
- concurrent or participation of a new clinical entity with the last 28 days
- treatment with a new specific anticancer agent (chemotherapy, targeted or hormonal therapy) or 
  radiation within the last 7 days
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University Of Queensland
Primary Sponsor Address: The University of Queensland Cumbrae-Stewart Building Research Road Brisbane Qld 4072
Primary Sponsor Country: Australia

Trial IDACTRN12619000037101

Contact person for information and recruitmentMs
Georgie Cupples
Clinical Trial Coordinator Palliative and Supportive Care Mater Misericordiae Ltd Raymond Terrace South Brisbane, Qld 4101
+61 7 3163 6057
+61 7 6163 1588
Further information iconGeorgie.Cupples@mater.org.au
Australia

A study that evaluates the effectiveness of oral medicinal cannabis for people with advanced cancer experiencing a range of symptoms.

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Trial Information

Trial summary

The purpose of this study is to assess whether cannabidoil (CBD) can be used to reduce total symptoms in patients with advanced cancer in palliative care.

Who is it for?

You may be eligible for this study if you are over 25 years of age and have been diagnosed with advanced cancer.

Study details

Participants will be randomly assigned to one of two treatment groups; either CBD or a placebo medication. 

Participants will be asked to take increasing doses of the study medication for 14 days, with the dose increasing until participants are satisfied with the symptom improvement and are experiencing no unacceptable side effects. After these 14 days, participants will be asked to take a steady dose of the medication for another set of 14 days. 

During the 28 days of the study you will be required to have a routine blood and urine test taken to determine if you are eligible. A further blood test will be taken at day 14 post trial analysis. 

It is hoped that this research will show a positive effect of CBD on symptoms for patients suffering with advanced cancer and thus provide an option in helping manage symptoms.

Broad Health ConditionCancer
Fatigue
Nausea
Breathlessness
Appetite
Psychological effects

Specific Health ConditionCancer
Any cancer

Trial FocusTreatment

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
QLD

Hospital
Mater Adult Hospital - South Brisbane

Hospital
Mater Private Hospital - South Brisbane

Hospital
St Vincent's Hospital Brisbane - Kangaroo Point

Hospital
Royal Brisbane & Womens Hospital - Herston

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
Gold Coast Hospital - Southport

Postcode
4101 - South Brisbane

Postcode
4169 - Kangaroo Point

Postcode
4029 - Herston

Postcode
4102 - Woolloongabba

Postcode
4215 - Southport

Anticipated date of first participant enrolment1/03/2019

Anticipated date of last participant enrolment1/03/2022

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patients with advanced histologically proven cancer (metastatic or locally advanced) known to the palliative care team:
-have an ESAS TSDS greater than 10
-at least one individual ESAS score greater than 3
-AKPS score >30
-aged >25yrs and above. English speaking (or have interpreter available)
--have a negative pregnancy urine test at eligibility (only if of reproductive potential) and agree to avoid pregnancy during the study and 12 weeks following the last dose of the study drug. Males must agree to avoid fathering a child and to not donate sperm during the study and for at least 12 weeks following the last dose of the study drug
-have a negative THC urine test
-able to tolerate oral medication and comply with trial requirments
-agree to use no other cannabis based products for the duration of the trial
-comply with trial requirements: agree to attend scheduled clinical appointments, adhere to dose titration schedule as directed
-understand it is illegal to take cannabinoid products outside of Australia
-understand that it is illegal to drive whilst taking cannabis products
-able to provide fully informed consent

Minimum age25 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

-a history of hypersensitivity to any cannabinoid product
-unstable untreated cardiovascular disease (hypertension, ischemic heart disease, congestive cardiac failure)
-severe hepatic impairment (total bilirubin >1.5 times the upper limit of the institution's normal range. Asparate aminotransferase (AST), and alanne aminotransferase (ALT) >3.0 time the upper limit of the institution's normal range; subjects with liver metastasis may have an AST and ALT of >5.0 times the upper limit of normal
-severe renal impairment (eGFR <20mls/min/1.73m2)
-history of psychiatric disorders (severe depression or anxiety, personality disorder, psychosis, schizophrenia, first degree relative with schizophrenia and/or suicidal ideation)
-cognitive impairment (SLUMS - St Louis University Mental Status) examination <20/30
-known substance use disorder (ASSIST - Alcohol, Smoking and Substance Involvement Screening Test) examination score >27+ 
-history that drug diversion may be a risk for them or their family/carers
-females who are pregnant or lactating
-concurrent or participation of a new clinical entity with the last 28 dyas
treatment with a new specific anticancer agent (chemotherapy, targeted or hormonal therapy) or radiation within the last 7 days
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University Of Queensland
Primary Sponsor Address: The University of Queensland Cumbrae-Stewart Building Research Road Brisbane Qld 4072
Primary Sponsor Country: Australia

Trial IDACTRN12618001220257

UTNNIL

Contact person for information and recruitmentMs
Georgie Cupples
Clinical Trial Coordinator Palliative and Supportive Care Mater Misericordiae Ltd Raymond Terrace South Brisbane, Qld 4101
+61 7 6163 6057
+61 7 3163 1588
Further information iconGeorgie.Cupples@mater.org.au
Australia

Cannabinoids and Acute Post-operative Pain in Participants having Stoma Reversal.

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Trial Information

Trial summary

This is a research study examining whether medicinal cannabis can safely be given to people who are having a surgical procedure involving the bowel.
When a person undergoes major surgery on the abdomen, care after the surgery involves the administration of medications that help relieve pain associated with the surgical procedure. Some of these drugs are called “opioids”. Most patients in this study will probably have had these drugs for the previous surgery in the form of morphine or “morphine-like” drugs given via the intravenous drip or a tablet taken by mouth. The side effects of these drugs include:
• Slowing of bowel function
• Sleepiness
• Slowed breathing
• Nausea and vomiting
• Decreased appetite
This study is not designed to test if medical cannabis is an effective pain management option, but rather seeks to assess if the drug can be safely administered and can be tolerated by patients having surgery such as your procedure and measure blood levels of cannabis chemicals.

Broad Health ConditionPost-operative pain
Ilesotomy reversal

Specific Health ConditionSurgery
Other surgery
Anaesthesiology
Pain management

Trial FocusTreatment

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
NSW

Hospital
John Hunter Hospital - New Lambton

Anticipated date of first participant enrolment29/04/2019

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

- Aged 18 years or older
- Signed written informed consent
- Undergoing reversal of ileostomy at participating hospital
- Willing and able to comply with all study requirements, including treatment, timing and assessments including blood tests, and,
- Undertaking by participant both male and female of child bearing potential to take reliable contraceptive precautions for the duration of therapy and for three months after discontinuation of therapy.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients from the above group will be excluded if they:
- Are pregnant, lactating, or using inadequate contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to study participation. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.
- Have severe renal impairment
- Unstable cardiovascular disease (uncontrolled hypertension, unstable ischaemic heart disease,
- History of epilepsy or recurrent seizures
- History of schizophrenia, other psychotic illness, severe personality disorder, suicidal ideation, or other significant psychiatric disorder, other than depression associated with underlying condition
- Substance use disorder to alcohol, opioids, benzodiazepines, or illicit stimulants
- Concomitant treatment with any potent CYP3A4 inhibitors such as ketoconazole, macrolides
- Is scheduled to receive any other investigational drug during the present study
- Prior hypersensitivity or intolerable adverse reaction to cannabis or cannabinoid based medications, 5HT3 antagonist, dexamethasone, NK1 antagonist
- have a known allergy or adverse drug reaction to cannabinoids and its excipients
- remain intubated post-procedure
Contact details and further information

Sponsor Primary Sponsor Type: Government body
Primary Sponsor Name: Hunter New England Local Health District
Primary Sponsor Address: Lokced Bag 1 Hunter Region Mail Centre NSW 2310
Primary Sponsor Country: Australia

Trial IDACTRN12618000612213

Contact person for information and recruitmentMs
Rosemary Carroll
Surgical Services John Hunter Hospital Locked Bag 1 Hunter Region Mail Centre NSW 2310
+61 2 49855153

Further information iconHNELHD-SurgeryResearch@health.nsw.gov.au
Australia

A trial to evaluate an oral medicinal cannabis extract compared with placebo for the treatment of insomnia.

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Trial Information

Trial summary

Insomnia is the most common sleep disorder.  Australian surveys have shown that 13-33% of the adult population have regular difficulty getting to sleep or staying asleep.
Previous studies have shown the benefit of synthetic delta-t-tetrahydrocannabinol (THC) and medical cannabis for a range of sleep disorders, however these trials were mainly targeted to investigate outcomes in other conditions such as pain and multiple sclerosis.  
The aim of this study is to provide preliminary evidence for orally delivered medical cannabis for the treatment of sleep disorders due to insomnia.  
This trial will enrol 24 participants aged (25-70) inclusive who have insomnia defined as self-reported difficulty initiating and/or maintaining sleep for 3 or more nights per week for at least 3 months.  Participants will also be screened with a clinically validated questionnaire for insomnia by an Investigator team member before being recruited into the trial. 
Participants involvement in the trial will be for approximately 8-11 weeks (depending on their availability to take the assessments).  After completing a series of health asessments and questionnaires relating to their sleep, participants will commence the trial with a 2 week period of baseline measures (without investigational product or placebo) where they will need to wear a wrist-worn device to measure their quantity and quality of their sleep, as well as complete a sleep diary.  On the final night of the 2 week period (night 14)  they will have an overnight sleep study at the sleep centre site using a non-invasive measuring device to measure sleep patterns and assessments with questionnaires about their sleep by the Investigator team.  Following a 1 week break, participants will be randomly allocated (by chance) to receive investigational product or placebo.  Each of the treatment phases of both investigational product and placebo will be for 2 week periods including a 1 week break in between the treatments.  The same requirements including measurements and assessments as per the baseline will be requried for each of the 2 week periods of investigational product and placebo.
This trial will provide information on the efficacy of medical cannabis for the treatment of sleep disorders due to insomnia.

Broad Health ConditionInsomnia

Specific Health ConditionNeurological
Other neurological disorders

Trial FocusTreatment

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
WA

Postcode
6009 - Crawley

Anticipated date of first participant enrolment4/02/2019

Anticipated date of last participant enrolment8/07/2019

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

a)	Has provided a dated informed consent form signed by them; and
b)	Is willing to comply with all study procedures and be available for the duration of the study; and
c)	Male or female aged 25 – 70 years ; and 
d)	Presence of chronic insomnia defined as self-reported difficulty initiating (latency to persistent sleep >30 min) and/or maintaining sleep (>30 mins awake, or waking >30 mins before desired waking time)) on three or more nights per week) for at least 3 months; and 
e)	Insomnia Severity Index score >10

Minimum age25 Years

Maximum age70 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

a)	Untreated cardiovascular disease, arrhythmias (other than well controlled atrial fibrillation), hypertension or severe heart failure; or
b)	History of allergies particularly to plant-based products containing terpenes, ie flavours and aromatic natural oils for example citrus, mango, lavender, thyme, cedarwood and pine products; or
c)	Known hypersensitivity to cannabinoids; or
d)	Currently regularly using (greater than or equal to 3 nights/days per week) psychotropic or CNS-active drugs (including cannabis, opioids, benzodiazepines); or
e)	Inability to refrain from use of psychotropic or CNS-active drugs (including cannabis, opioids, benzodiazepines) for at least one week prior to and duration of study; or 
f)	Inability to refrain from use of Cytochrome P450 inhibitors for at least one week prior to and duration of study.  Examples include macrolide antibiotics (erythromycin, clarithromycin), azole antifungals (itraconazole, ketoconazole, posaconazole, voriconazole), protease inhibitors (ritonavir, telaprevir, boceprevir), calcium channel blockers (amlopdipine), high cholesterol medication (gemfibrozil), cyclosporine, danazol, tachycardia medication (amiodarone), hypertension medication (verapamil, diltiazem), niacin (vitamin B3 greater than 1g/ day), grapefruit juice; or
g)	Untreated metabolic disorders such as diabetes; or
h)	Presence of severe depression, severe anxiety or other severe psychopathologic conditions based on self-report or depression scores on the DASS greater than or equal to 21, or anxiety scores on the DASS greater than or equal to 16; or
i)	History of suicide attempt or current suicide ideation (response greater than 0 to Question 9 of PHQ-9); or
j)	History of seizures or epilepsy; or
k)	History of drug or alcohol abuse; or 
l)	Insomnia associated with sleep apnea (AHI greater than 15 events/hour) or movement disorders such as restless legs, periodic limb movement (PLM) (greater than 30 events/hour or greater than 5 events/hour with associated PLM arousals); or
m)	Are currently participating in a formal behavioural therapy program to facilitate sleep; or
n)	Current cannabis use (less than 2 months prior); or
o)	Pregnancy or lactation; or
p)	Inability to refrain from greater than 2 standard drinks/day of alcohol consumption for study duration; or
q)	Inability to refrain from greater than 400mg/day of caffeine consumption for study duration; or
r)	Shift workers or other workers and athletes who require testing and screening for cannabis products as part of their employment; or 
s)	Any person required to drive within 10 hours of dose, or those with a self-reported history of falling asleep while driving; or
t)	Current delayed sleep phase syndrome where wake up time is regularly later than 8.00am.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Zelda Therapeutics Limited
Primary Sponsor Address: Level 45, 108 St Georges Tce, Perth WA, 6000
Primary Sponsor Country: Australia

Trial IDACTRN12618000078257

Contact person for information and recruitmentDr
Kathleen Maddison
Manager, Centre for Sleep Science School of Anatomy, Physiology and Human Biology, The University of Western Australia 35 Stirling Highway, Crawley WA 6009
+61 8 6488 8689

Further information iconkathleen.maddison@uwa.edu.au
Australia

The buccal administration of a NanoCelle™ Cannabidiol formulation to healthy volunteers: a pharmacokinetic, safety and tolerability exploratory pilot study.

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Trial Information

Trial summary

This is a single blinded randomised placebo-controlled study. This study will be performed in healthy subjects to determine the pharmacokinetic, safety and tolerability characteristics of a novel Cannabidiol formulation in the form of an oro-buccal spray. The drug contains 6 mg CBD and <0.3 mg other cannabinoids (including THC)/0.3 mL in 2 actuations of the pump (equals 1 dose).

Broad Health ConditionThe Investigational Product may be indicated for anxiety
The Investigational Product may be indicated for mood symptoms
The Investigational Product may be indicated for insomnia
The Investigational Product may be indicated for the treatment of inflammatory pain

Specific Health ConditionAlternative and Complementary Medicine
Herbal remedies

Trial FocusTreatment

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
NSW

Hospital
Scientia Clinical Research - Randwick

Postcode
2031 - Randwick

Anticipated date of first participant enrolment20/02/2019

Phase of TrialPhase 0

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1)	Participants greater or equal to 18 years of age at time of entry on the study; 
2)	Cognitive ability to understand informed consent process and to give and sign informed consent to the experimental treatment; 
3)	Participants agree to undergo insertion of an indwelling cannula once for approximately 48 hours with multiple blood draws; 
4)	Participants agree to adhere to the study protocol; 
5)	 No history of illicit drug use (e.g., including but not limited to natural or synthetic cannabinoid compounds); 
6)	No history of any chronic diseases;
7)	Agree to not driving a car for at least 7 days post administration of the final dose of the IP on Day 2.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

1)	Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, clinical chemistry, haematology, urinalysis, vital signs;
2)	Current or previous allergies or allergic responses to herbal medicines of any kind; 
3)	Active substance abuse (alcohol or drug dependency);
4)	The current use of any illicit drugs (e.g., cannabis in any form); 
5)	Pregnant or nursing an infant; 
6)	Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant; 
7)	Elevated liver enzymes 2x normal limits; 
8)	The current use of any dietary and herbal supplements;
9)	The current use of any over-the-counter or prescription medications.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Medlab Clinical
Primary Sponsor Address: 66 McCauley Street, Alexandria, New South Wales, 2015
Primary Sponsor Country: Australia

Trial IDACTRN12617001491358

Contact person for information and recruitmentMiss
Serena Dal Forno
Medlab Clinical. 66 McCauley Street, Alexandria, New South Wales 2015
1300 369 570 Ext. 120

Further information iconserena_dalforno@medlab.co
Australia

Double blind, randomised, placebo controlled trial of Sativex for the management of cannabis withdrawal

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Trial Information

Trial summary

The primary objective of the study is to examine the safety and efficacy of SATIVEX 'Registered Trademark (R)' in the inpatient management of cannabis withdrawal, in a double blinded randomised trial compared to placebo. Specifically, the study will compare withdrawal severity, detoxification completion and adverse events between the two conditions in an intention-to-treat analysis. Secondary objectives include 1-month post-withdrawal outcomes (including cannabis and other drug use and psychosocial outcomes), and to assess the relationship between the number, severity and duration of cannabis withdrawal symptoms and rates of continuous and point prevalence abstinence from cannabis, time to relapse, levels of cannabis use, and cannabis related problems at one month follow-up. The study will also explore the cognitive impact of withdrawing from cannabis, as well as the impact of SATIVEX on cognitive functioning, with an aim to assessing the real world safety profile of the drug ahead of larger outpatient studies. The study will also explore the pharmacokinetics and metabolites associated with SATIVEX (R) administration to develop a protocol for differentiating between SATIVEX(R) and illicit cannabis in blood or urine among those entering cannabis withdrawal treatment. This pharmacokinetic assay will prove useful for future large scale outpatient trials should the current trial prove successful. A final exploratory objective of the study is to determine whether there is evidence of an interaction with the efficacy of SATIVEX(R) and patient characteristics on admission (including demographics and cannabis and other use and psychosocial factors such as treatment expectancy) on reported severity of cannabis withdrawal and subsequent post-withdrawal outcomes (cannabis use, psychosocial outcomes, sleep disturbances and cannabis-related problems) to be fully tested in a larger community study.

Broad Health ConditionCannabis withdrawal

Specific Health ConditionPublic Health
Health service research
Mental Health
Addiction

Trial FocusTreatment

Recruitment statusNot yet recruiting


Postcode
2000

Postcode
2300

Anticipated date of first participant enrolment31/07/2011

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Between 18-65 years of age (Both males and females)
2. Regular recent cannabis use (average of 5 times per week – self report)
3. Meet DSM-IV-TR 'Registered Trademark' criteria for cannabis dependence
4. Has made unsuccessful quit attempts in the past                 		
5. Desire to give up cannabis
6. Prepared to enter a hospital ward for 9 days

If NO to any (1 - 6) client is not eligible for SATIVEX trial phone screen, provide usual referral/treatment advice.

Minimum age18 Years

Maximum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. More than twice weekly use of an illicit drug in the last 30 days (other than cannabis)
2. Dependence on a substance other than cannabis and tobacco
3. Pregnant or breastfeeding
4. Female of child bearing potential NOT using contraception
5. Evidence of severe medical impairment (e.g. chronic pain, severe hepatic impairment or cardiovascular disease)
6. Evidence of severe cognitive or psychiatric impairment (e.g. bipolar, schizophrenia, suicidal ideation)
7. Current (within past month) prescription for antipsychotic or mood stabilising medications   
8. Currently prescribed warfarin
9. Allergy to cannabinoids, propylene glycol, ethanol or peppermint oil
10. Not English literate
 11. Specialist substance use treatment in the last 30 days
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of New South Wales
Primary Sponsor Address: The University of New South Wales SYDNEY NSW 2052 AUSTRALIA
Primary Sponsor Country: Australia

Trial IDACTRN12611000398909

UTNU1111-1120-7086

Contact person for information and recruitment
Professor Jan Copeland
National Cannabis Prevention and Information Centre, NDARC, UNSW, Sydney NSW, 2052, Australia
+61 2 9385 0208
+61 2 9385 0201
Further information iconj.copeland@unsw.edu.au
Australia

Hair drug analysis to identify cases of drug-facilitated sexual assault

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Trial Information

Trial summary

The purpose of this study is to compare hair drug analysis with urine and blood drug analysis which is currently used for investigating allegations of drug facilitated sexual assault (DFSA). Our hypothesis is that hair drug analysis will detect additional drugs than those detected in urine and blood samples.
In addition, we hope to document drugs involved in suspicions of DFSA in the South Australian population, identify which drugs may have improved detection with hair toxicology and document time frames for drug detection in different biological specimens.

Broad Health ConditionDrug facilitated sexual assault

Specific Health ConditionOther
Research that is not of generic health relevance and not applicable to specific health categories listed above

Trial FocusDiagnosis

Recruitment statusNot yet recruiting

Anticipated date of first participant enrolment1/06/2010

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Attending the Yarrow Place Rape and Sexual Assault Service
Alleged or concern of sexual assault
Participant belief or concern and/or clinical suspicion of drug facilitation

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

People who are bald.
People undergoing chemotherapy or radiotherapy involving the head.
Inability to attend follow-up visit
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Tanya Boast
Primary Sponsor Address: Lyell McEwin Health Service, Haydown Road, Elizabeth Vale, SA 5112
Primary Sponsor Country: Australia

Trial IDACTRN12610000365066

Contact person for information and recruitment
Dr Tanya Boast
Lyell McEwin Health Service, Haydown Road, Elizabeth Vale SA 5112
+61 8 8182 9279

Further information iconTanya.Boast@health.sa.gov.au
Australia