Dextroamphetamine as an Adjunct in Cocaine Treatment - 1

• Sponsor: National Institute on Drug Abuse (NIDA) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00000304
• Collaborator: University of Texas (Other)
• Enrollment: 120
• Location: 1
• Arms: 3
• Duration (Months): 48
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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

• Study Type: Interventional
• 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: Aug 1, 1997
• Actual Primary Completion Date: Aug 1, 2001
• Actual Study Completion Date: Aug 1, 2001

Arms and Interventions

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

Primary Outcome Measures

1. verifiable cocaine abstinence [16 weeks of study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Health Science Center	Houston	Texas	United States	77225

Sponsors and Collaborators

• National Institute on Drug Abuse (NIDA)
• University of Texas

Investigators

• Principal Investigator: John Grabowski, Ph.D., University of Texas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00000304
• Other Study ID Numbers: NIDA-09262-1; P50-09262-1
• First Posted: Sep 21, 1999
• Last Update Posted: Jan 12, 2017
• Last Verified: Oct 1, 2016

• Keywords provided by , ,: cocaine dependence
• Additional relevant MeSH terms: Disease; Substance-Related Disorders; Cocaine-Related Disorders; Amphetamine; Dextroamphetamine

Study Results

No Results Posted as of Jan 12, 2017