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

Primary Purpose

Cannabis Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Clonazepam
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder focused on measuring Marijuana, Treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 18-65 years of age

Exclusion Criteria:

  • Individuals with a lifetime DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
  • Individuals meeting current DSM-5 criteria for any other psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or non-pharmacological intervention over the course of the study. Individuals who are currently stable on a psychotropic medication for at least 3 months may be included if in the investigator's opinion the psychotropic medication is compatible with the study medication (clonazepam). CNS depressants (e.g., benzodiazepines, opioids, adrenergic agonists) and cyp3A4 inhibitors (ketoconazole, some antipsychotics & anticonvulsants) will be exclusionary.
  • 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

Sites / Locations

  • Substance Treatment Research Service (STARS) of Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Clonazepam

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
September 22, 2016
Last Updated
July 15, 2021
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02913924
Brief Title
Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients
Official Title
Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients: Combined Inpatient/Outpatient Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder
Keywords
Marijuana, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clonazepam
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Clonazepam
Other Intervention Name(s)
Klonopin
Intervention Description
fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matched Placebo
Primary Outcome Measure Information:
Title
Time to Cannabis Use Relapse
Description
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.
Time Frame
Number of days during 12 weeks of study participation
Title
Proportion of Cannabis Use Days Per Week
Description
for outpatient participants the proportion of cannabis use days per week as recorded by the Timeline Followback method
Time Frame
the 7 weeks of study participation or length of participants participation during the medication maintenance phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 18-65 years of age Exclusion Criteria: Individuals with a lifetime DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder Individuals meeting current DSM-5 criteria for any other psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or non-pharmacological intervention over the course of the study. Individuals who are currently stable on a psychotropic medication for at least 3 months may be included if in the investigator's opinion the psychotropic medication is compatible with the study medication (clonazepam). CNS depressants (e.g., benzodiazepines, opioids, adrenergic agonists) and cyp3A4 inhibitors (ketoconazole, some antipsychotics & anticonvulsants) will be exclusionary. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Mariani, MD
Organizational Affiliation
New York Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Substance Treatment Research Service (STARS) of Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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