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

NCT02913924 | Completed Phase 2 Results DMC

• 2 other identifiers: 7343U54DA037842-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cannabis Use Disorder

Keywords

Marijuana; Treatment

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Clonazepam

EXPERIMENTAL

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.

Drug: Clonazepam

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Clonazepam DRUG

fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial

Also known as: Klonopin

Clonazepam

Placebo DRUG

Also known as: Matched Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets DSM 5 criteria for CUD of at least moderate severity (≥ 4 symptoms) and is seeking treatment for cannabis use.
• Reports using cannabis a minimum of 5 days per week over the past 28 days and have positive urine test for THC on the day of study entry
• years of age

You may not qualify if:

• Individuals with a lifetime DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
• Known history of allergy, intolerance or hypersensitivity to benzodiazepines
• Episodic or chronic use of benzodiazepines
• Pregnancy, lactation, or failure to use adequate contraceptive methods (condoms, diaphragm, birth control pill, IUD) in female patients who are currently engaging in sexual activity with men.
• Unstable medical conditions, such as poorly controlled hypertension, which might make participation hazardous
• Participants with a current DSM-5 diagnosis of an alcohol of substance use disorder (abuse or dependence) other than cannabis or nicotine use disorder
• Are legally mandated to participate in a substance use disorder treatment program
• Increased risk for suicide
• Current parole or probation
• Recent history of significant violent behavior
• History of current of past diagnosis of glaucoma
• History of benzodiazepine or other sedative hypnotic use disorder

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Substance Treatment Research Service (STARS) of Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Clonazepam

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: John Mariani MD
• Organization: New York State Psychiatric Institute

john.mariani@nyspi.columbia.edu

646-774-8181

Study Officials

• John Mariani, MD

  New York Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research psychiatrist

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 26, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 6, 2021
• Results First Posted: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)