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

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT00893269

Collaborator

Food and Drug Administration (FDA) (U.S. Fed), National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Marijuana Dependence	Drug: eszopiclone Drug: Placebo Drug: ramelteon Drug: zolpidem	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Medication Participants receive active hypnotic medication prior to sleep	Drug: eszopiclone Oral capsule at dose recommended for adults Drug: ramelteon ramelteon Drug: zolpidem zolpidem
Placebo Comparator: Placebo Participants receive placebo prior to sleep	Drug: Placebo Participants receive placebo prior to sleep

Arm

Intervention/Treatment

Experimental: Active Medication

Participants receive active hypnotic medication prior to sleep

Drug: eszopiclone

Oral capsule at dose recommended for adults

Drug: ramelteon

ramelteon

Drug: zolpidem

zolpidem

Placebo Comparator: Placebo

Participants receive placebo prior to sleep

Drug: Placebo

Participants receive placebo prior to sleep

Outcome Measures

Primary Outcome Measures

Marijuana Withdrawal [Every day during study participation]

Secondary Outcome Measures

Objective Sleep Assessment [Every day during study participation]
Cognitive Performance [Every day during study participation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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