Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/2/2018 |
| Start Date: | September 2016 |
| End Date: | April 2020 |
| Contact: | Elizabeth Martinez |
| Phone: | 212-923-3031 |
Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients: Combined Inpatient/Outpatient Study
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.
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.
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.
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.
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
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