The Role of Sleep in the Treatment of Cannabis Use Disorders
This study is currently recruiting participants.
Verified September 2012 by Johns Hopkins University
Sponsor:
Johns Hopkins University
Collaborator:
Information provided by (Responsible Party):
Ryan Vandrey, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01685073
First received: September 11, 2012
Last updated: September 12, 2012
Last verified: September 2012
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Purpose
The number of people seeking treatment for marijuana-related problems is on the rise, yet there is no currently accepted medication proven to help them quit. Frequent marijuana users have reported that they have trouble sleeping when they try to quit, and that the loss of sleep can lead to relapse. This research is designed to measure the severity of sleep problems in people as they are trying to quit heavy use of marijuana, and to investigate whether extended-release zolpidem (Ambien CR®) can improve quit rates among people trying to stop using marijuana.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug Addiction |
Drug: Zolpidem extended-release Behavioral: MET/CBT |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Role of Sleep in the Treatment of Cannabis Use Disorders |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- Sleep Efficiency [ Time Frame: up to 24 Weeks ] [ Designated as safety issue: No ]Sleep will be objectively measured at 5 time points during the study assessment period using ambulatory polysomnography (PSG) equipment.
- Cannabis Abstinence [ Time Frame: Twice weekly on Weeks 1-12; Week 24 and 36 ] [ Designated as safety issue: No ]Urine drug testing will determine whether study participants are abstinent from cannabis use throughout participation in treatment (12 weeks) and at 3- and 6-month follow-up assessments
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Zolpidem
Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder
|
Drug: Zolpidem extended-release
nightly administration of zolpidem extended-release
Other Name: Ambien CR
Behavioral: MET/CBT
a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants
|
|
Placebo Comparator: Placebo
Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder
|
Behavioral: MET/CBT
a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Age 18-55 years.
- Recent problematic use of cannabis
- Cannabis use impacts sleep
Exclusion Criteria:
- Dependent on drugs other than cannabis or nicotine, or current Axis I psychiatric disorder
- Moderate sleep apnea or periodic limb movement disorder
- Pregnant, breast feeding, or planning to become pregnant within the next 3 months
- Current condition associated with severe cognitive/social impairment
- Allergy to any ingredient in extended-release zolpidem or prior adverse reaction to zolpidem
- Current use of drugs that affect metabolism via cytochrome P450 or current illness resulting in severe hepatic impairment
- Current use of hypnotic medications
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685073
Contacts
| Contact: Jeannie Murray, MS | 410-550-2695 | jfry4@jhmi.edu |
Locations
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Jeannie Murray, MS 410-550-2695 jfry4@jhmi.edu | |
| Principal Investigator: Ryan Vandrey, PhD | |
Sponsors and Collaborators
Johns Hopkins University
Investigators
| Principal Investigator: | Ryan Vandrey, PhD | Johns Hopkins University |
More Information
No publications provided
| Responsible Party: | Ryan Vandrey, Assistant Professor, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01685073 History of Changes |
| Other Study ID Numbers: | NA_00068969 |
| Study First Received: | September 11, 2012 |
| Last Updated: | September 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johns Hopkins University:
|
marijuana cannabis treatment insomnia relapse |
Additional relevant MeSH terms:
|
Substance-Related Disorders Behavior, Addictive Mental Disorders Compulsive Behavior Impulsive Behavior Zolpidem Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses GABA-A Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013