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

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ClinicalTrials.gov Identifier: NCT00893269
Recruitment Status : Completed
First Posted : May 5, 2009
Last Update Posted : December 5, 2013
Sponsor:
Collaborators:
Food and Drug Administration (FDA)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Ryan Vandrey, Johns Hopkins University

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 Type : Interventional  (Clinical Trial)
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 : October 2008
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Marijuana Withdrawal [ Time Frame: Every day during study participation ]

Secondary Outcome Measures :
  1. Objective Sleep Assessment [ Time Frame: Every day during study participation ]
  2. Cognitive Performance [ Time Frame: Every day during study participation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893269


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

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
R21DA025794 ( U.S. NIH Grant/Contract )
First Posted: May 5, 2009    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: December 2013

Keywords provided by Ryan Vandrey, Johns Hopkins University:
marijuana
cannabis
dependence
withdrawal

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