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

Marijuana Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893269
• Other study ID #: NA_00017909
• Secondary ID: R21DA025794
• Status: Completed
• Phase: Phase 1
• First received: April 30, 2009
• Last updated: December 3, 2013
• Start date: October 2008
• Est. completion date: October 2010

Study information

• Verified date: December 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Dependence

Intervention

Drug:
• eszopiclone
Oral capsule at dose recommended for adults
• Placebo
Participants receive placebo prior to sleep
• ramelteon
ramelteon
• zolpidem
zolpidem

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marijuana Withdrawal		Every day during study participation	No
Secondary	Objective Sleep Assessment		Every day during study participation	No
Secondary	Cognitive Performance		Every day during study participation	No