The Effect of Prescription Medications in Marijuana Users

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 Recruiting

First Received on April 30, 2009. Last Updated on July 15, 2011 History of Changes

Sponsor:	Johns Hopkins University
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00893074

Purpose

A subset of heavy marijuana users have trouble quitting marijuana use and the number of those seeking treatment for problems related to marijuana is increasing. The purpose of this research study is to investigate whether certain medications can reduce withdrawal effects associated with stopping marijuana use, if they can reduce the rewarding effects of smoked marijuana, and whether there are any cognitive performance deficits associated with the medications that produce such effects.

Condition	Intervention	Phase
Marijuana Abuse	Drug: bupropion, diazepam, dronabinol, ramelteon (Investigational Drug)	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	The Effect of Prescription Medications in Marijuana Users

Resource links provided by NLM:

MedlinePlus related topics: Marijuana

Drug Information available for: Bupropion hydrochloride Bupropion GW-1000 Ramelteon Diazepam Tetrahydrocannabinol 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 ]
subjective effects of smoked marijuana [ Time Frame: Every 5-9 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

cognitive performance [ Time Frame: Every 5-9 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	21
Study Start Date:	April 2009
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Marijuana Use Period during which participants are free to self administer marijuana
Experimental: Marijuana Abstinence Period during which marijuana use is prohibited and study medication is administered	Drug: bupropion, diazepam, dronabinol, ramelteon (Investigational Drug) multiple doses of an investigational drug administered three times per day, double blind during brief periods of marijuana abstinence Other Names: buproprion diazepam dronabinol ramelteon

Eligibility

Ages Eligible for Study:	18 Years and older
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
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: NCT00893074

Contacts

Contact: Sarah Ilk

410-550-0007

Locations

United States, Maryland
Behavioral Pharmacology Research Unit	Recruiting
Baltimore, Maryland, United States, 21224
Contact: Sarah Ilk 410-550-0007
Principal Investigator: Ryan Vandrey, Ph.D.

Sponsors and Collaborators

Johns Hopkins University

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Ryan Vandrey, Ph.D.

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Ryan Vandrey, Ph.D., Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier:	NCT00893074 History of Changes
Other Study ID Numbers:	NA_00026278, R01-DA025044
Study First Received:	April 30, 2009
Last Updated:	July 15, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

withdrawal
acute effects
cognitive performance
Marijuana Use
Marijuana Abstinence

Additional relevant MeSH terms:

Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Diazepam
Tetrahydrocannabinol
Bupropion
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents

Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on February 09, 2012