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Trial registered on ANZCTR


Registration number
ACTRN12607000165482
Ethics application status
Approved
Date submitted
7/03/2007
Date registered
12/03/2007
Date last updated
30/01/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
An open lable pilot study of rimonabant
Scientific title
An open label pilot study of rimonabant, a cannabinoid receptor type 1 antagonist, for over sixteen to thirty year old cannabis users with a history of psychosis, participating in a structured treatment program to assess whether relapse to dependant cannabis is reduced
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dependant cannabis usage 1671 0
Psychosis 1672 0
Condition category
Condition code
Mental Health 1775 1775 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
As the trial is a pilot study all 20 participants will be prescribed 20mg of Rimonabant (trade name Acomplia) in tablet form to be taken every morning before breakfast for three months, until day 84 follow up assessment. The client will then be followed up at day 168 after a 3 month period where they have not been taking the study medication.
Intervention code [1] 1637 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2481 0
The number of days the client used cannabis in the previous 28 days using the following measures: Drug use diary, Modified Opioid Treatment Index (OTI) and Urinalysis
Timepoint [1] 2481 0
Measured at day 28, 84 and 168
Primary outcome [2] 2482 0
Their retention in treatment using the measures: Clinical observation - follow up rates, Morisky Scale for medication compliance
Timepoint [2] 2482 0
Measured at day 28, 84 and 168
Secondary outcome [1] 4260 0
Clinical observations- including physical observations, Self report including adverse reactions.
Timepoint [1] 4260 0
The frequency of side effects at day 2, 7, and 28, 84.
Secondary outcome [2] 4261 0
Clinical observation, including weight, body mass index (BMI) and waist circumference
Timepoint [2] 4261 0
Weight at day 28, 84 and 168
Secondary outcome [3] 4262 0
Drug use diary, Modified Opioid Treatment Index (OTI) and Urinalysis.
Timepoint [3] 4262 0
Other drug usage at day 28, 84, 168
Secondary outcome [4] 4263 0
General Health Questionnaire, Brief Psychiatric Rating Scale (BPRS), Health Service Utilization Scale, Self report any medical illness since last review.
Timepoint [4] 4263 0
Mental health status day 28, 84, 168
Secondary outcome [5] 4264 0
Measures: Health Service Utilization Scale
Timepoint [5] 4264 0
Utilisation of other health services at day 28, 84, 168

Eligibility
Key inclusion criteria
1. Aged 16-30 years2.If the client is under 18, 2 medical officers will be required to assess them, to ensure their eligibility and safety in order to participate in the trial.3.History of cannabis dependence (DSM-IV criteria for cannabis dependence)4.Not in cannabis withdrawal 5.History of psychosis6.Satisfactory completion of pre-study screening7.Willing to comply with protocol8.Agree to sign informed consent
Minimum age
16 Years
Maximum age
30 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Severe hepatic impairment 2.Severe renal impairment3.Taking potent CYP3A4 inhibitors (eg. ketoconazole, itraconoazole, ritonavir, clarithromycin) 4.Taking potent CYP3A4 inducers (eg. Rifampicin, phenytoin, phenobarbital, carbamazepine, St John’s wort)5.Known galactose intolerance 6.Known allergy to rimonabant 7.Pregnant or lactating8.Significant suicidal ideation9.Severe psychosis interfering with ability to give informed consent 10.Judged by research personnel to be unwilling, unable or unlikely to comply with protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pilot study design
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1925 0
Government body
Name [1] 1925 0
Mental Health, Drug and Alcohol Co-morbidity
Address [1] 1925 0
North Sydney
Country [1] 1925 0
Australia
Primary sponsor type
Hospital
Name
The Langton Centre
Address
South Dowling Street
Surry Hills NSW 2010
Country
Australia
Secondary sponsor category [1] 1737 0
Charities/Societies/Foundations
Name [1] 1737 0
Mental Health, Drug and Alcohol Co-morbidity
Address [1] 1737 0
Randwick
Country [1] 1737 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3581 0
The Langton Centre
Ethics committee address [1] 3581 0
Ethics committee country [1] 3581 0
Australia
Date submitted for ethics approval [1] 3581 0
Approval date [1] 3581 0
05/02/2007
Ethics approval number [1] 3581 0
06/270
Ethics committee name [2] 3582 0
Ted Noffs Foundation
Ethics committee address [2] 3582 0
Ethics committee country [2] 3582 0
Australia
Date submitted for ethics approval [2] 3582 0
Approval date [2] 3582 0
05/02/2007
Ethics approval number [2] 3582 0
06/270
Ethics committee name [3] 3583 0
Eastern Suburbs Early Intervention Centre
Ethics committee address [3] 3583 0
Ethics committee country [3] 3583 0
Australia
Date submitted for ethics approval [3] 3583 0
Approval date [3] 3583 0
05/02/2007
Ethics approval number [3] 3583 0
06/270

Summary
Brief summary
To trial the administration of a new drug “rimonabant”, a selective cannabinoid receptor type I antagonist, to young people between the ages of 16- 30 who have a history of psychosis and have undergone a period of cannabis detoxification, to assess whether relapse to dependant cannabis use is reduced

It is hypothesised that:
1.Rimonabant will reduce the effects of cannabis intoxication after cannabis detoxification.
2.In turn, this would reduce psychosis and depression, and hence reduce utilization of health services including hospitalization.
3.Rimonabant will reduce other substance use disorders including tobacco use
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27571 0
Address 27571 0
Country 27571 0
Phone 27571 0
Fax 27571 0
Email 27571 0
Contact person for public queries
Name 10826 0
Anni Ryan
Address 10826 0
The Langton Centre
591 South Dowling street
Surry Hills NSW 2010
Country 10826 0
Australia
Phone 10826 0
(02) 93328753
Fax 10826 0
(02) 9332 8700
Email 10826 0
Anni.Ryan@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 1754 0
Mark Montebello
Address 1754 0
The Langton Centre
591 South Dowling street
Surry Hills 2010
Country 1754 0
Australia
Phone 1754 0
(02) 9332 8799
Fax 1754 0
(02) 9332 8700
Email 1754 0
Mark.Montebello@SESIAHS.HEALTH.NSW.GOV.AU

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary