The Role of Sleep in the Treatment of Cannabis Use Disorders

Johns Hopkins University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Drug Addiction

Treatments: Drug: Zolpidem extended-release; Behavioral: MET/CBT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01685073

U01DA031784 (U.S. NIH Grant/Contract)

NA_00068969

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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127 participants in 2 patient groups, including a placebo group

Zolpidem

Experimental group

Description:

Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder

Treatment:

Behavioral: MET/CBT

Drug: Zolpidem extended-release

Placebo

Placebo Comparator group

Description:

Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder

Treatment:

Behavioral: MET/CBT