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

Official Title: “The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep”

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Active Medication
  • Participants receive active hypnotic medication prior to sleep
• Placebo Comparator: Placebo
  • Participants receive placebo prior to sleep

Primary Measures

• Marijuana Withdrawal
  • Time Frame: Every day during study participation
    Safety Issue?: No

Secondary Measures

• Objective Sleep Assessment
  • Time Frame: Every day during study participation
    Safety Issue?: No
• Cognitive Performance
  • Time Frame: Every day during study participation
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Johns Hopkins University Other

Overall Clinical Trial Officials and Contacts

Ryan Vandrey, Ph.D. Principal Investigator Johns Hopkins University  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00893269

Study ID Number: NA_00017909

ClinicalTrials.gov Identifier: NCT00893269

Health Authority: United States: Food and Drug Administration