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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
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
John Mariani MD, New York State Psychiatric Institute

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.


Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Drug: Clonazepam Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Clonazepam

Arm Intervention/treatment
Experimental: Clonazepam
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
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.
Drug: Placebo
Other Name: Matched Placebo




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 4 weeks
  • 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
  • Participants taking psychotropic medication
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Elizabeth Martinez 212-923-3031
Contact: Amy Mahony, LMHC 646-774-8183

Locations
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United States, New York
Substance Treatment Research Service (STARS) of Columbia University Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: John Mariani, MD New York Psychiatric Institute

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Responsible Party: John Mariani MD, research psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02913924     History of Changes
Other Study ID Numbers: 7343
U54DA037842-01 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John Mariani MD, New York State Psychiatric Institute:
Marijuana
Treatment

Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Clonazepam
Anticonvulsants
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs