Expired Study
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Houston, Texas 77225


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.


Criteria:

Please contact site for information.


Study is Available At:


Original ID:

NIDA-09262-1


NCT ID:

NCT00000304


Secondary ID:

P50-09262-1


Study Acronym:


Brief Title:

Dextroamphetamine as an Adjunct in Cocaine Treatment - 1


Official Title:

Dextroamphetamine as an Adjunct in Cocaine Treatment


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Drug Abuse (NIDA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

120


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:August 1997
Completion Date:August 2001
Completion Type:Actual
Primary Completion Date:August 2001
Primary Completion Type:Actual
Verification Date:October 2016
Last Changed Date:January 11, 2017
First Received Date:September 20, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:verifiable cocaine abstinence
Time Frame:16 weeks of study
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Dextroamphetamine
Description:15 mg for first 8 weeks and 30 mg for 2nd 8 weeks
Arm Name:1
Intervention Type:Drug
Name:D-Amphetamine
Description:30 mg for the first 8 weeks and 60 for the second 8 weeks (16 weeks total)
Arm Name:2
Intervention Type:Drug
Name:Placebo
Description:Placebo
Arm Name:3

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:15/30 mg d-amphetamine
Study Arm Type:Experimental
Arm Name:2
Description:30/60 mg d-amphetamine
Study Arm Type:Experimental
Arm Name:3
Description:placebo

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Drug Abuse (NIDA)
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Texas

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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