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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:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00893074
First received: April 30, 2009
Last updated: July 15, 2011
Last verified: May 2009
  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:


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
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):
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
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Diazepam
Dronabinol
Adjuvants, Anesthesia
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Anticonvulsants
Antiemetics
Autonomic Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Gastrointestinal Agents
Hallucinogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Muscle Relaxants, Central
Neuromuscular Agents

ClinicalTrials.gov processed this record on November 25, 2014