Search results from the Australian New Zealand Clinical Trials Registry

Your query returned 3 records. Results are sorted by Trial Registration date with most recent record appearing first.

Too many results? You may wish to search again and include different criteria such as your State or Age Group.

Search Parameters
Keyword: cannabinoid
Recruitment Status: Not yet recruiting

Refine Results
ACTNSWNTQLDSATASVICWA

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

Print record Print record
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

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

Print record Print record
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

Print record Print record
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