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Treatment of Cocaine Dependence: Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo

NCT ID: NCT00218348

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2007-11-30

Brief Summary

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Dextro-amphetamine sulfate is a central nervous system stimulant that increases the release of the neurotransmitter dopamine in the brain. The purpose of this study is to further examine dose ranges of dextro-amphetamine sulfate as a treatment for cocaine dependence.

Detailed Description

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This randomized, double-blind dose study will compare the effectiveness of three active medication doses of dextro-amphetamine sulfate to placebo in the treatment of cocaine dependence. Participants will be randomly assigned to one of the four following dosages of dextro-amphetamine sulfate: 0 mg, 40 mg, 60 mg, or 80 mg. Participants will undergo a 2-week stabilization period followed by a 25-week study period. The study period will include administration of the stable medication dose for 21 weeks, followed by 1 week of dose reduction, and then 3 weeks without medication. All participants will receive weekly cognitive behavioral therapy and electrocardiograms. Participants will be given the option to participate in a voluntary plasma blood draw during Weeks 4, 8, and 20 and will be scheduled for follow-up assessments at Months 1 and 3 post-treatment.

Conditions

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Cocaine-Related Disorders

Keywords

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Cocaine Abuse Dextro-Amphetamine Sulfate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Dextro-Amphetamine Sulfate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* DSM-IV diagnosis of cocaine dependence, as determined by the Structured Clinical Interview for DSM-IV
* Agreement to use an adequate method of contraception for the duration of the study
* Electrocardiogram confirmation by a cardiologist
* Cocaine-positive urine test prior to study entry

Exclusion Criteria

* High blood pressure
* Significant heart disease
* Clinically significant cardiovascular abnormality
* Angina
* Kidney, liver, or gastrointestinal disorder
* Current Axis I disorder not related to drug use
* Current dependence on any drug other than nicotine
* Attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD)
* On probation or parole for reasons other than those related to drug abuse charges
* Pregnant or breastfeeding
* Sought treatment for drug dependence within 3 months prior to study entry
* Currently taking prescribed medications
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Joy Schmitz

Professor - Psy, Behavioral Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joy M Schmitz, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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R01DA016305

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01-16305-1

Identifier Type: -

Identifier Source: secondary_id

DPMC

Identifier Type: -

Identifier Source: secondary_id

NIDA-16305-1

Identifier Type: -

Identifier Source: org_study_id