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| Sponsor: | Bankole Johnson |
|---|---|
| Collaborator: |
National Institute on Drug Abuse (NIDA) |
| Information provided by (Responsible Party): | Bankole Johnson, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00249691 |
Purpose
Although a great amount of research has been conducted to resolve cocaine dependence, an effective treatment has yet to be discovered. Topiramate is a drug that was found to be useful in treating alcohol dependence. The purpose of this study is to determine the effectiveness of topiramate in treating cocaine dependent individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine-Related Disorders |
Drug: Topiramate + Cognitive Behavioral Therapy Drug: Placebo + Cognitive Behavioral Therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Medication Development for Cocaine Dependence |
| Estimated Enrollment: | 180 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Topiramate |
Drug: Topiramate + Cognitive Behavioral Therapy
Topiramate up to 300 mg per day
Other Name: Topamax
|
| Placebo Comparator: Placebo |
Drug: Placebo + Cognitive Behavioral Therapy
Placebo twice a day
Other Name: Sugar Pill
|
Despite considerable scientific effort in the last two decades to develop treatment for cocaine dependent individuals, no medication has proven to be effective for treating cocaine dependence. Cocaine's rewarding effects are primarily a result of altering nerve pathways involving dopamine, a naturally-occurring chemical in the brain. Past research has focused on developing medications that either block dopamine or inhibit its release. However, these medications have not proven effective in treating cocaine dependence. This study will evaluate a new strategy of treating cocaine dependence by altering dopamine's functional expression. Dopamine-associated expression may be mediated through inhibition of gamma-aminobutyric acid (GABA), another brain chemical. Topiramate is a GABA inhibitor that has proven effective in treating alcohol dependent individuals. The purpose of this study is to determine the efficacy of topiramate in treating cocaine dependent individuals.
Participants will be randomly assigned to receive either 300 mg per day of topiramate or placebo. In addition, participants will receive weekly cognitive behavioral therapy for 12 weeks. Follow-up visits will occur at 2 weeks and 1, 2, and 3 months following completion of treatment, and will include evaluations of cocaine use and psychosocial functioning.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Virginia | |
| UVA CARE | |
| Charlottesville, Virginia, United States, 22911 | |
| UVA CARE Richmond | |
| Richmond, Virginia, United States, 23294 | |
| Principal Investigator: | Bankole Johnson | University of Virginia |
More Information
| Responsible Party: | Bankole Johnson, Chair of Psychiatry and Neurobehavioral Sciences, University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00249691 History of Changes |
| Other Study ID Numbers: | 11578, R01DA017296, DPMC |
| Study First Received: | November 3, 2005 |
| Last Updated: | February 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
cocaine addiction cocaine dependence |
|
Cocaine-Related Disorders Substance-Related Disorders Mental Disorders Cocaine Topiramate Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants Neuroprotective Agents Protective Agents Anti-Obesity Agents |