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

Johns Hopkins University

Status and phase: Completed; Phase 1

Conditions: Marijuana Dependence

Treatments: Drug: eszopiclone; Drug: zolpidem; Drug: Placebo; Drug: ramelteon

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT00893269

R21DA025794 (U.S. NIH Grant/Contract)

NA_00017909

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

Active Medication

Experimental group

Description:

Participants receive active hypnotic medication prior to sleep

Treatment:

Drug: eszopiclone

Drug: zolpidem

Drug: ramelteon

Placebo

Placebo Comparator group

Description:

Participants receive placebo prior to sleep

Treatment:

Drug: Placebo