Drug Addiction | The Role of Sleep in the Treatment of Cannabis Use Disorders
Drug Addiction research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. Age 18-55 years. 2. Recent problematic use of cannabis 3. Cannabis use impacts sleep Exclusion Criteria: 1. Dependent on drugs other than cannabis or nicotine, or current Axis I psychiatric disorder 2. Moderate sleep apnea or periodic limb movement disorder 3. Pregnant, breast feeding, or planning to become pregnant within the next 3 months 4. Current condition associated with severe cognitive/social impairment 5. Allergy to any ingredient in extended-release zolpidem or prior adverse reaction to zolpidem 6. Current use of drugs that affect metabolism via cytochrome P450 or current illness resulting in severe hepatic impairment 7. Current use of hypnotic medications
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Zolpidem extended-releasenightly administration of zolpidem extended-release
Behavioral:MET/CBTa 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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ZolpidemParticipants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder
PlaceboParticipants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder
Start Date: September 2012
Completed Date: July 2018
Phase: Phase 2/Phase 3
Primary Outcome: Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed
Study sponsors, principal investigator, and references
Principal Investigator: Ryan Vandrey, PhD
Lead Sponsor: Johns Hopkins University
Collaborator: National Institute on Drug Abuse (NIDA)