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

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.

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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

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