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

Cocaine-Related Disorders Clinical Trial

Official title:

Pharmacotherapy for Cocaine Dependence - 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218348
• Other study ID #: NIDA-16305-1
• Secondary ID: R01DA016305R01-1
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: December 16, 2017
• Start date: September 2003
• Est. completion date: November 2007

Study information

• Verified date: December 2017
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Dextro-Amphetamine Sulfate

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance use and retention
Secondary	Effectiveness measures, including psycho-social variables, side effects, and self-reported measures