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The Effect of Prescription Medications in Marijuana Users
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Johns Hopkins University.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Johns Hopkins University
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
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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 Intervention Model: Crossover Assignment Masking: Double Blind (Participant, 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 ]
- subjective effects of smoked marijuana [ Time Frame: Every 5-9 days ]
Secondary Outcome Measures:
- cognitive performance [ Time Frame: Every 5-9 days ]
| 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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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
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 R01DA025044 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | April 30, 2009 |
| Last Updated: | July 15, 2011 |
Keywords provided by Johns Hopkins University:
|
withdrawal acute effects cognitive performance Marijuana Use Marijuana Abstinence |
Additional relevant MeSH terms:
|
Marijuana Abuse Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Bupropion Dronabinol Diazepam Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents |
Neurotransmitter Agents Physiological Effects of Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Hallucinogens Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Adjuvants, Anesthesia |
ClinicalTrials.gov processed this record on June 22, 2017