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

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT00893074

First received: April 30, 2009

Last updated: July 15, 2011

Last verified: May 2009

History of Changes

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 1 Phase 2


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: Diazepam Dronabinol 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 ]
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

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: 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 by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lee D, Vandrey R, Milman G, Bergamaschi M, Mendu DR, Murray JA, Barnes AJ, Huestis MA. Oral fluid/plasma cannabinoid ratios following controlled oral THC and smoked cannabis administration. Anal Bioanal Chem. 2013 Sep;405(23):7269-79. doi: 10.1007/s00216-013-7159-8. Epub 2013 Jul 6.

Vandrey R, Stitzer ML, Mintzer MZ, Huestis MA, Murray JA, Lee D. The dose effects of short-term dronabinol (oral THC) maintenance in daily cannabis users. Drug Alcohol Depend. 2013 Feb 1;128(1-2):64-70. doi: 10.1016/j.drugalcdep.2012.08.001. Epub 2012 Aug 22.


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 Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Dronabinol Analgesics Analgesics, Non-Narcotic Central Nervous System Agents Hallucinogens	Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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