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| Sponsor: | University of Pennsylvania |
|---|---|
| Information provided by: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00368290 |
Purpose
The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces high risk behavior in cocaine dependent subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Dependence |
Drug: Modafinil Drug: placebo Behavioral: Cognitive Behavioral Therapy (CBT) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Modafinil Treatment for Cocaine Dependence and HIV-High Risk Behavior |
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
modafinil plus CBT
|
Drug: Modafinil
300mg a day for 8 weeks
Other Name: Provigil
Behavioral: Cognitive Behavioral Therapy (CBT)
Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
|
|
Placebo Comparator: 2
placebo plus CBT
|
Drug: placebo
placebo pills for 8 weeks
Behavioral: Cognitive Behavioral Therapy (CBT)
Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
|
The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces HRB in cocaine dependent subjects. Modafinil (300 mg/day) or placebo will be administered in an 8-week double-blind trial to patients meeting diagnostic criteria for cocaine dependence in conjunction with Cognitive Behavioral Therapy (CBT).
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nicole Basta | 215-222-3200 ext 180 | basta_n@mail.trc.upenn.edu |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Donna Simpson 215-243-9959 | |
| Principal Investigator: | Kyle M Kampman, M.D. | University of Pennsylvania |
More Information
| Responsible Party: | Kyle M. Kampman, M.D., University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00368290 History of Changes |
| Other Study ID Numbers: | 804537 |
| Study First Received: | August 22, 2006 |
| Last Updated: | November 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
cocaine dependence hiv prevention |
|
Cocaine-Related Disorders Substance-Related Disorders Mental Disorders Cocaine Modafinil 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 Central Nervous System Stimulants Neuroprotective Agents Protective Agents |