NCT02913924

Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients

Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients: Combined Inpatient/Outpatient Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients seeking treatment for Cannabis Use Disorder (CUD) will be enrolled into an inpatient laboratory for 5 nights, where they will be initiated on medication and be assessed for the influence of clonazepam (or placebo) on (1) cannabis withdrawal (mood, sleep, cannabis craving, food intake), ratings associated with medication abuse liability, cognitive performance, and (2) relapse to cannabis use after patients (now abstinent from cannabis) leave the inpatient setting maintained on clonazepam (or placebo) for 8 weeks (with a 4-week, medication-free follow up). This combined design will provide a comprehensive understanding of clonazepam's effects on individuals with cannabis use disorder across a range of outcome measures (safety, abuse liability, withdrawal symptoms) while also testing the medication's ability to prevent relapse in cannabis-abstinent patients. Patient's who are unable to complete the inpatient approach will complete the 12 week trial as an outpatient only.

Conditions

• Cannabis Use Disorder

Interventions

Type	Name	Description
DRUG	Clonazepam	fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial
DRUG	Placebo

Timeline

• Start date: 2016-12-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2016-09-26
• Last updated: 2021-08-06
• Results posted: 2021-08-06

Locations

1 site across 1 country: United States