The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep

Phase 1

Completed

• Conditions: Marijuana Dependence
• Interventions: Drug: eszopiclone; Drug: Placebo; Drug: ramelteon; Drug: zolpidem

• Registration Number: NCT00893269
• Lead Sponsor: Johns Hopkins University

Brief Summary

Heavy marijuana users report experiencing trouble sleeping when they try to quit, but this has not been carefully studied. This research is being done to learn more about sleep function in heavy marijuana users, and to determine whether a medication approved for treating insomnia can help restore normal sleep function during brief periods of abstinence.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-05-04
• Study First Posted: 2009-05-05
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• current use of marijuana
• able to give informed consent

Exclusion Criteria

• dependence on drug other than marijuana
• current sleep disorder
• pregnant, breast feeding, or planning to become pregnant within the next 3 months
• currently seeking treatment for cannabis-related problems or otherwise trying to reduce use
• use of cannabis under the guidance of a physician for a medical disorder
• unstable or uncontrolled cardiovascular disease (e.g., hypertension, angina)
• allergy to study medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Medication	eszopiclone	Participants receive active hypnotic medication prior to sleep
Placebo	Placebo	Participants receive placebo prior to sleep
Active Medication	ramelteon	Participants receive active hypnotic medication prior to sleep
Active Medication	zolpidem	Participants receive active hypnotic medication prior to sleep

Primary Outcome Measures

Name	Time	Method
Marijuana Withdrawal	Every day during study participation

Secondary Outcome Measures

Name	Time	Method
Objective Sleep Assessment	Every day during study participation
Cognitive Performance	Every day during study participation

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States