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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2009 by Johns Hopkins University. Recruitment status was Active, not recruiting

First Received on April 30, 2009. Last Updated on February 1, 2011 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 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:

MedlinePlus related topics: Marijuana

Drug Information available for: Zolpidem Zolpidem tartrate Eszopiclone Ramelteon

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 2011
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

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)

National Institute on Drug Abuse (NIDA)

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):

Vandrey R, Umbricht A, Strain EC. Increased blood pressure after abrupt cessation of daily cannabis use. J Addict Med. 2011 Mar;5(1):16-20.

Vandrey R, Smith MT, McCann UD, Budney AJ, Curran EM. Sleep disturbance and the effects of extended-release zolpidem during cannabis withdrawal. Drug Alcohol Depend. 2011 Aug 1;117(1):38-44. Epub 2011 Feb 5.

Responsible Party:	Ryan Vandrey, 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:	February 1, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

marijuana
cannabis
dependence
withdrawal

Additional relevant MeSH terms:

Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Zolpidem
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2012