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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
---|---|
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00480441 |
This treatment study is targeted specifically for those who want to stop using marijuana. We want to find out if patients who are dependent on marijuana and want to stop using are helped by a combination of the drug dronabinol and six sessions of individual therapy (BRENDA). Dronabinol is a pill form of the active ingredient in marijuana (THC). Currently, dronabinol is approved for the treatment of nausea in people receiving cancer chemotherapy and as an appetite stimulant in people with AIDS.
In some studies, dronabinol reduced the amount of psychological and physical discomfort experienced when people stopped using marijuana. One purpose of our study is to see if people who are on dronabinol have fewer problems with psychological and physical discomfort than those who are on a placebo.
In addition to treatment, this research trial will also be measuring the reactions of subjects to drug-related cues, and also to computer-presented tasks unrelated to drug use. We may examine whether the response to these cues/tasks either predicts treatment outcome, or is affected by your treatment. This information may also help us to understand the ways in which chronic drug use causes changes in our subjects' mental functioning and how those changes respond to treatment.
In addition to participation in the treatment research trial, some subjects may be asked to undergo a brain scan in an MRI. The purpose of the brain scan research project is to measure brain reactions with a non-invasive, non-radioactive imaging technique known as fMRI (functional magnetic resonance imaging) in marijuana subjects before and after treatment with the medication dronabinol or with an inactive substance (placebo).
Condition | Intervention | Phase |
---|---|---|
Marijuana Dependence |
Drug: Dronabinol Behavioral: BRENDA therapy Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase II Double-Blind Placebo-Controlled Trial of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal |
Estimated Enrollment: | 60 |
Study Start Date: | August 2006 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Dronabinol+ BRENDA therapy
|
Drug: Dronabinol
10mg capsules taken 4 times daily for 2 weeks and then tapered over 1 week
Behavioral: BRENDA therapy
weekly therapy sessions for 6 weeks
|
2: Placebo Comparator
Placebo+BRENDA therapy
|
Behavioral: BRENDA therapy
weekly therapy sessions for 6 weeks
Drug: Placebo
4 capsules daily for 2 weeks followed by a 1 week taper
|
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Female subjects who are pregnant or lactating, or female subjects of child bearing potential who are not using acceptable methods of birth control.
Acceptable methods of birth control include:
Barrier (diaphragm or condom) with spermicide, Intrauterine device, Levonorgestrel implant, Medroxyprogesterone acetate contraceptive injection, Oral contraceptives.
Additional Neuroimaging Exclusion Criteria:
Subjects who are selected for the clinical trial based on above inclusion and exclusion criteria will be screened further with the following exclusion criteria for possible participation in the fMRI imaging session:
Contact: Marina Goldman, M.D. | 215 222 3200 ext 104 | goldman_m@mail.trc.upenn.edu |
Contact: Kyle Kampman, M.D. | 215 222 3200 | kampman_k@mail.trc.upenn.edu |
United States, Pennsylvania | |
Treatment Research Center at the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Principal Investigator: Marina Goldman, M.D. | |
Sub-Investigator: Kyle Kampman, M.D. | |
Sub-Investigator: Anna Rose Childress, Ph.D. | |
Sub-Investigator: Ronald Ehrman, Ph.D. | |
Sub-Investigator: Marta MacDougall, Psy.D. | |
Sub-Investigator: Jessie Suh, Psy.D. |
Principal Investigator: | Charles O'Brien, M.D./Ph.D. | Treatment Research Center at the University of Pennsylvania |
Responsible Party: | University of Pennsylvania ( Marina Goldman, M.D. ) |
Study ID Numbers: | 5-P60-DA-005186-19 |
Study First Received: | May 30, 2007 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00480441 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Marijuana Addiction Substance Withdrawal Syndrome Clinical Trial Dronabinol Behavioral Therapy |
Adults Neuroimaging Neuropsychological Testing Neurocognitive Testing Behavioral Probes |
Tetrahydrocannabinol Behavior, Addictive Substance Withdrawal Syndrome Analgesics, Non-Narcotic Mental Disorders Psychotropic Drugs |
Substance-Related Disorders Disorders of Environmental Origin Peripheral Nervous System Agents Analgesics Marijuana Abuse |
Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Hallucinogens Marijuana Abuse Pharmacologic Actions Tetrahydrocannabinol Sensory System Agents |
Mental Disorders Analgesics, Non-Narcotic Therapeutic Uses Substance-Related Disorders Peripheral Nervous System Agents Analgesics Central Nervous System Agents |