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| Sponsored by: |
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 women.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Dependence |
Drug: Modafinil Drug: placebo Behavioral: Telephone Monitoring and Adaptive Counseling (TMAC) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Community-Based Modafinil Treatment of Women With 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 |
|---|---|
|
1: Experimental
modafinil plus TMAC
|
Drug: Modafinil
300mg a day for 8 weeks
Behavioral: Telephone Monitoring and Adaptive Counseling (TMAC)
Weekly telephone counseling sessions for a period of 8 weeks following a 1hr face-to-face interview.
|
|
2: Placebo Comparator
placebo plus TMAC
|
Drug: placebo
placebo pills for 8 weeks
Behavioral: Telephone Monitoring and Adaptive Counseling (TMAC)
Weekly telephone counseling sessions for a period of 8 weeks following a 1hr face-to-face interview.
|
The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces HRB in cocaine dependent women. 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 Telephone Monitoring and Adaptive Counseling (TMAC).
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Thea L Gallis | 215-222-3200 ext 131 | gallis_t@mail.trc.upenn.edu |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Donna Simpson 215-243-9959 | |
| Principal Investigator: | Charles Dackis, M.D. | University of Pennsylvania |
More Information
| Responsible Party: | University of Pennsylvania ( Charles Dackis, MD ) |
| Study ID Numbers: | 804537 |
| Study First Received: | August 22, 2006 |
| Last Updated: | January 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00368290 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
cocaine dependence hiv prevention |
|
Cocaine-Related Disorders Dopamine Uptake Inhibitors Neurotransmitter Agents Acquired Immunodeficiency Syndrome Central Nervous System Depressants Anesthetics Disorders of Environmental Origin Central Nervous System Stimulants Cardiovascular Agents Neuroprotective Agents |
Anesthetics, Local Modafinil Dopamine HIV Infections Mental Disorders Substance-Related Disorders Vasoconstrictor Agents Dopamine Agents Peripheral Nervous System Agents Cocaine |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Disorders of Environmental Origin Anesthetics Neuroprotective Agents Modafinil Mental Disorders Sensory System Agents Therapeutic Uses Vasoconstrictor Agents |
Substance-Related Disorders Cocaine Cocaine-Related Disorders Central Nervous System Depressants Central Nervous System Stimulants Cardiovascular Agents Protective Agents Pharmacologic Actions Anesthetics, Local Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |