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

Information source: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine-Related Disorders

Intervention: Dextro-Amphetamine Sulfate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Joy M Schmitz, PhD, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston


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.

Clinical Details

Official title: Pharmacotherapy for Cocaine Dependence - 1

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Substance use and retention

Secondary outcome: Effectiveness measures, including psycho-social variables, side effects, and self-reported measures

Detailed 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.


Minimum age: 25 Years. Maximum age: 50 Years. Gender(s): Both.


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

Locations and Contacts

Department of Psychiatry, Mental Services, Houston, Texas 77030, United States
Additional Information

Starting date: September 2003
Last updated: January 7, 2009

Page last updated: August 20, 2015

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