Search results from the Australian New Zealand Clinical Trials Registry

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The effect of cannabidiol (CBD) on simulated driving performance.

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Trial Information

Trial summary

This study is a randomised, crossover, double-blinded, single-dose experimental trial investigating the dose-dependent effects of purified, oral cannabidiol (CBD) on simulated car driving performance in healthy individuals. Participants will complete four experimental sessions involving different CBD treatments: (1) Placebo (0mg); (2) Low dose (15mg); (3) Moderate dose (300mg); and (4) High dose (1500mg). Trials will be conducted at the Woolcock Institute of Medical Research. We hypothesise that no dose of CBD will affect simulated car driving performance. Findings may assist to inform the development of guidelines and/or laws relating to the use of CBD drug therapies by drivers. 

Broad Health ConditionRoad Trauma

Specific Health ConditionInjuries and Accidents
Other injuries and accidents

Trial FocusPrevention

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
NSW

Anticipated date of first participant enrolment18/11/2019

Anticipated date of last participant enrolment1/06/2020

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

(a)	Between 18 and 65 years of age;
(b)	No reported use of cannabis within the past 3 months; to be confirmed by a negative urine drug screen at the medical screening;
(c)	In possession of full (unrestricted) Australian driver’s license for at least 1 y; 
(d)	Proficient in English (i.e. must not require an English translator). 

Minimum age18 Years

Maximum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

(a)	Cannabis dependence or any other drug or alcohol dependence, as per the International Statistical Classification of Diseases 10th Revision criteria or at the medical officer’s discretion;
(b)	Contraindications to cannabinoids, including clinically significant prior adverse response to cannabis, cannabinoid products or synthetic cannabinoids (e.g. panic, anxiety attacks, arrhythmia, falls, seizures or other);
(c)	History of a major psychiatric disorder within the previous 12 months (except clinically managed mild depression) as per the Diagnostic and Statistical Manual of Mental Disorders-V criteria or at the medical officer’s discretion;
(d)	History of attempted suicide or current suicide ideation as determined by a score >0 on Question 9 of the Patient Health Questionnaire-9;
(e)	A diagnosed sleep disorder, as per the International Classification of Sleep Disorders Diagnostic and Coding manual or at the medical officer’s discretion;     
(f)	Pregnant or lactating. All female volunteers of childbearing potential will be required to complete a human chorionic gonadotrophin (hCG) urine screen to rule out pregnancy at the medical screening; females of childbearing potential and males with a female partner must agree to use a reliable form of contraception during and one month following their participation in this project;
(g)	Inability to refrain from alcohol consumption 24 h prior to each experimental trial;
(h)	Inability to refrain from using other central nervous system active drugs (e.g. opioids, benzodiazepines) while participating in this project; 
(i)	Use of medications that may influence CBD metabolism, such as inducers or inhibitors of the CYP450 enzyme system;
(j)	Use of medications handled by transporter proteins or CYP enzymes that are inhibited by CBD, such as anticoagulants, calcium channel blockers, beta-blockers and sulfonylureas;
(k)	Use of anticonvulsive medications, such as clobazam or valproate;
(l)	Required to complete mandatory drug testing for cannabis (e.g. workplace testing; court order); 
(m)	A high habitual caffeine (i.e. >300 mg·d-1);
(n)	At risk for developing driving simulator sickness, as determined at the medical screening using the Simulator Sickness Questionnaire; 
(o)	Body mass index (BMI) >30 kg·m2
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Sydney
Primary Sponsor Address: Camperdown New South Wales Australia 2050
Primary Sponsor Country: Australia

Trial IDACTRN12619001552178

UTNU1111-1239-7155

Contact person for information and recruitmentDr
Danielle McCartney
Brain and Mind Centre (Level 6) 94 Mallet Street Camperdown New South Wales Australia 2050
+61 02 9351 0783

Further information icondanielle.mccartney@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

Hospital
Orange Health Service - Orange

Hospital
The Chris O’Brien Lifehouse - Camperdown

Postcode
2800 - Orange

Postcode
2050 - Camperdown

Anticipated date of first participant enrolment25/02/2020

Anticipated date of last participant enrolment1/02/2023

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

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

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