Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients
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|ClinicalTrials.gov Identifier: NCT02913924|
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : October 31, 2018
The proposed protocol is a double-blind, placebo-controlled inpatient and outpatient study,looking at the clinical treatment of cannabis use disorder.
The treatment study is a total of 12 weeks. There will be two options offered to participants for week 1 of the treatment study. 1) Patient will go inpatient for 5 nights and after discharge from the inpatient phase will complete the 11-weeks of outpatient treatment or 2) patients who cannot complete the inpatient phase due to work or other obligations will complete the treatment 12-week study outpatient. 80 patients seeking treatment for cannabis use disorder will be enrolled into either the inpatient/outpatient or only outpatient study. This combined design will provide a comprehensive understanding of clonazepam's effects on individuals with cannabis use disorder across a range of outcome measures while also testing the medication's ability to prevent relapse in cannabis-abstinent patients.
|Condition or disease||Intervention/treatment||Phase|
|Cannabis Use Disorder||Drug: Clonazepam Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients: Combined Inpatient/Outpatient Study|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||April 2020|
Clonazepam will be taken twice per day in the morning and in the evening. Clonazepam is given in a "fixed flexible" dose schedule with the dose titrated to 2mg per day or the maximum tolerated dose. Clonazepam will be taken for the first 8 weeks of the trial.
fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial
Other Name: Klonopin
Placebo Comparator: Placebo
Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial.
Other Name: Matched Placebo
- Time to cannabis use relapse [ Time Frame: Number of days during 12 weeks of study participation ]for inpatient participants the number of days till relapse to cannabis use, post inpatient discharge, as recorded on the time line follow-back and confirmed by urine toxicology result.
- cannabis abstinent days per week [ Time Frame: the 12 weeks of study participation or length of participants participation ]for outpatient participants the number of abstinent days per week as recorded by the Timeline Followback method and confirmed by quantitative urine THC levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913924
|Contact: Elizabeth Martinez||212-923-3031|
|Contact: Amy Mahony, LMHC||646-774-8183|
|United States, New York|
|Substance Treatment Research Service (STARS) of Columbia University||Recruiting|
|New York, New York, United States, 10032|
|Principal Investigator:||John Mariani, MD||New York Psychiatric Institute|