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| 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: | Basic Science, Non-Randomized, Double Blind (Subject, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study |
| Official Title: | The Effect of Prescription Medications in Marijuana Users |
| Estimated Enrollment: | 21 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Marijuana Use: No Intervention
Period during which participants are free to self administer marijuana
|
|
|
Marijuana Abstinence: Experimental
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sarah Ilk | 410-550-0007 |
| 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. | |
| Principal Investigator: | Ryan Vandrey, Ph.D. | Johns Hopkins University |
More Information
| Responsible Party: | Johns Hopkins University School of Medicine ( Ryan Vandrey, Ph.D. ) |
| Study ID Numbers: | NA_00026278, R01-DA025044 |
| Study First Received: | April 30, 2009 |
| Last Updated: | May 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00893074 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
withdrawal acute effects cognitive performance Marijuana Use Marijuana Abstinence |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Hallucinogens Anesthetics Antiemetics Disorders of Environmental Origin Neuromuscular Agents Sensory System Agents Mental Disorders Therapeutic Uses Muscle Relaxants, Central Hypnotics and Sedatives |
Substance-Related Disorders Analgesics Anesthetics, Intravenous Tranquilizing Agents Diazepam Gastrointestinal Agents Central Nervous System Depressants Marijuana Abuse Pharmacologic Actions Adjuvants, Anesthesia Tetrahydrocannabinol Analgesics, Non-Narcotic Autonomic Agents Anesthetics, General GABA Agents |
