Verified September 2016 by New York State Psychiatric Institute
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT02913924
First received: September 22, 2016
Last updated: September 22, 2016
Last verified: September 2016
The protocol is a double-blind, placebo-controlled inpatient and outpatient study, combining an inpatient model of cannabis withdrawal with a clinical treatment of cannabis use disorder using clonazepam versus placebo. 80 patients seeking treatment for cannabis use disorder will be enrolled into the inpatient phase for 5 nights. After discharge from the inpatient phase, 12-weeks of outpatient treatment will be conducted. 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.
| Cannabis Use Disorder | Drug: Clonazepam Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients: Combined Inpatient/Outpatient Study |
- Time to cannabis use relapse [ Time Frame: Number of days during 12 weeks of study participation ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2016 |
| Estimated Study Completion Date: | April 2020 |
| Estimated Primary Completion Date: | January 2020 (Final data collection date for primary outcome measure) |
| 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 |
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.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 an average 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02913924
| Contact: Elizabeth Martinez | 212-923-3031 | ||
| Contact: Amy Mahony, LMHC | 646-774-8183 |
| Substance Treatment Research Service (STARS) of Columbia University | |
| New York, New York, United States, 10032 | |
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
| Principal Investigator: | John Mariani, MD | New York Psychiatric Institute |
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT02913924 History of Changes |
| Other Study ID Numbers: | 7343 U54DA037842-01 |
| Study First Received: | September 22, 2016 |
| Last Updated: | September 22, 2016 |
| Health Authority: | United States: Food and Drug Administration |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Keywords provided by New York State Psychiatric Institute:
| Marijuana Treatment |
Additional relevant MeSH terms:
| 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 |
ClinicalTrials.gov processed this record on September 26, 2016