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

This study has been completed.
Sponsor:
Collaborators:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Ryan Vandrey, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00893269
First received: April 30, 2009
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Marijuana Dependence
Drug: eszopiclone
Drug: Placebo
Drug: ramelteon
Drug: zolpidem
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Marijuana Withdrawal [ Time Frame: Every day during study participation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Sleep Assessment [ Time Frame: Every day during study participation ] [ Designated as safety issue: No ]
  • Cognitive Performance [ Time Frame: Every day during study participation ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: October 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Medication
Participants receive active hypnotic medication prior to sleep
Drug: eszopiclone
Oral capsule at dose recommended for adults
Other Name: eszopiclone
Drug: ramelteon
ramelteon
Other Name: ramelteon
Drug: zolpidem
zolpidem
Other Name: zolpidem
Placebo Comparator: Placebo
Participants receive placebo prior to sleep
Drug: Placebo
Participants receive placebo prior to sleep

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893269

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Food and Drug Administration (FDA)
Investigators
Principal Investigator: Ryan Vandrey, Ph.D. Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ryan Vandrey, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00893269     History of Changes
Other Study ID Numbers: NA_00017909, R21-DA025794
Study First Received: April 30, 2009
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
marijuana
cannabis
dependence
withdrawal

Additional relevant MeSH terms:
Marijuana Abuse
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Eszopiclone
Zolpidem
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Agonists
GABA-A Receptor Agonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014