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

This study is currently recruiting participants.

Verified by Johns Hopkins University, May 2009

First Received: April 30, 2009 Last Updated: May 4, 2009 History of Changes

Sponsor:	Johns Hopkins University
Collaborators:	Food and Drug Administration (FDA) National Institute on Drug Abuse (NIDA)
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00893269

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 I

Study Type:	Interventional
Study Design:	Basic Science, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title:	The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep

Resource links provided by NLM:

MedlinePlus related topics: Marijuana

Drug Information available for: GW-1000 Zolpidem Eszopiclone Ramelteon Cannabis

U.S. FDA Resources

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 ]

Estimated Enrollment:	35
Study Start Date:	October 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Medication: Experimental Participants receive active hypnotic medication prior to sleep	Drug: eszopiclone Oral capsule at dose recommended for adults Drug: ramelteon ramelteon Drug: zolpidem zolpidem
Placebo: Placebo Comparator 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

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

Contacts

Contact: Sarah Ilk	410-550-0007	silk1@jhmi.edu
Contact: Erin Curran	410-550-2695	ecurran4@jhmi.edu

Locations

United States, Maryland
Johns Hopkins University	Recruiting
Baltimore, Maryland, United States, 21224
Contact: Sarah Ilk 410-550-0007 silk1@jhmi.edu
Principal Investigator: Ryan Vandrey, Ph.D.

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

More Information

No publications provided

Responsible Party:	Johns Hopkins University ( Ryan Vandrey )
Study ID Numbers:	NA_00017909, R21-DA025794
Study First Received:	April 30, 2009
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00893269 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

marijuana
cannabis
dependence
withdrawal

Additional relevant MeSH terms:

Zolpidem
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Disorders of Environmental Origin
Central Nervous System Depressants
Marijuana Abuse
Pharmacologic Actions

Mental Disorders
Therapeutic Uses
GABA Agonists
Hypnotics and Sedatives
Substance-Related Disorders
GABA Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010