An open lable pilot study of rimonabant

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000165482

Enrollment

Registered

2007-03-12

Start date

2007-02-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to 30 Years

Healthy volunteers

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

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.

Outcome results