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| Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of Texas |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00000304 |
Purpose
The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in cocaine treatment; an evaluation of the ""replacement"" strategy.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine-Related Disorders Substance-Related Disorders |
Drug: Dextroamphetamine Drug: D-Amphetamine Drug: Placebo |
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: | Dextroamphetamine as an Adjunct in Cocaine Treatment |
| Enrollment: | 120 |
| Study Start Date: | August 1997 |
| Study Completion Date: | August 2001 |
| Primary Completion Date: | August 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
15/30 mg d-amphetamine
|
Drug: Dextroamphetamine
15 mg for first 8 weeks and 30 mg for 2nd 8 weeks
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2: Experimental
30/60 mg d-amphetamine
|
Drug: D-Amphetamine
30 mg for the first 8 weeks and 60 for the second 8 weeks (16 weeks total)
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3: Experimental
placebo
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Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Please contact site for information.
Contacts and Locations| United States, Texas | |
| University of Texas Health Science Center | |
| Houston, Texas, United States, 77225 | |
| Principal Investigator: | John Grabowski, Ph.D. | University of Texas |
More Information
| Responsible Party: | University of Texas Medical School at Houston ( F.Gerard Moeller ) |
| Study ID Numbers: | NIDA-09262-1, P50-09262-1 |
| Study First Received: | September 20, 1999 |
| Last Updated: | August 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000304 |
| Health Authority: | United States: Federal Government |
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Cocaine-Related Disorders Methamphetamine Dopamine Mental Disorders Dextroamphetamine |
Substance-Related Disorders Disorders of Environmental Origin Amphetamine Cocaine |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Sympathomimetics Physiological Effects of Drugs |
Central Nervous System Stimulants Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |
