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Dextroamphetamine as an Adjunct in Cocaine Treatment - 1

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ClinicalTrials.gov Identifier: NCT00000304
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
University of Texas
Information provided by:
National Institute on Drug Abuse (NIDA)

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cocaine-Related Disorders Substance-Related Disorders Drug: Dextroamphetamine Drug: D-Amphetamine Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dextroamphetamine as an Adjunct in Cocaine Treatment
Study Start Date : August 1997
Actual Primary Completion Date : August 2001
Actual Study Completion Date : August 2001

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
15/30 mg d-amphetamine
 Drug: Dextroamphetamine
15 mg for first 8 weeks and 30 mg for 2nd 8 weeks
Experimental: 2
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)
Experimental: 3
placebo
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. verifiable cocaine abstinence [ Time Frame: 16 weeks of study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000304


Locations
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United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77225
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
University of Texas
Investigators
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Principal Investigator: John Grabowski, Ph.D. University of Texas
More Information
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Responsible Party: F.Gerard Moeller, University of Texas Medical School at Houston
ClinicalTrials.gov Identifier: NCT00000304    
Other Study ID Numbers: NIDA-09262-1
P50-09262-1
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2016
Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Cocaine-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Amphetamine
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
 Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors