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

The University of Texas System (UT)

Status and phase

Completed

Phase 2

Conditions

Cocaine-Related Disorders

Treatments

Drug: Dextro-Amphetamine Sulfate

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00218348

R01DA016305 (U.S. NIH Grant/Contract)

NIDA-16305-1

R01-16305-1

DPMC

Details and patient eligibility

About

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.

Full description

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.

Enrollment

186 patients

Sex

All

Ages

25 to 50 years old

Volunteers

No Healthy Volunteers

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