NCT02913924|CompletedPhase 2ResultsDMC
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Sponsor study identifier
Secondary identifiers
interventional
68
1 country
1
Study Start
December 2016
Actual (reported)Primary Completion
June 2020
Actual (reported)Study Completion
June 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 22, 2016
Actual (reported)September 26, 2016
Actual (reported)December 2016
Actual (reported)June 2020
Actual (reported)June 2020
Actual (reported)August 6, 2021
Actual (reported)Time to Cannabis Use Relapse
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.
Number of days during 12 weeks of study participation
Proportion of Cannabis Use Days Per Week
for outpatient participants the proportion of cannabis use days per week as recorded by the Timeline Followback method
the 7 weeks of study participation or length of participants participation during the medication maintenance phase
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.
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.
fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial
Substance Treatment Research Service (STARS) of Columbia University
New York, New York, 10032, United States
John Mariani, MD
New York Psychiatric Institute
68 participants (actual enrollment reported by the registry).
First Submitted
September 22, 2016
First Posted
September 26, 2016
Study Start
December 2016
Actual (reported)Cannabidiol and Cannabis Concentrate Users
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 2020
Actual (reported)Study Completion
June 2020
Actual (reported)Last Updated
August 6, 2021
Results First Posted
August 6, 2021
Record last verified: 2021-07
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Source: ClinicalTrials.gov.
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