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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218348
First received: September 16, 2005
Last updated: January 7, 2009
Last verified: January 2009

September 16, 2005
January 7, 2009
September 2003
January 2008   (final data collection date for primary outcome measure)
Substance use and retention
Same as current
Complete list of historical versions of study NCT00218348 on ClinicalTrials.gov Archive Site
Effectiveness measures, including psycho-social variables, side effects, and self-reported measures
Effectiveness measures including psycho-social variables, side effects, and self-reported measures
Not Provided
Not Provided
 
Treatment of Cocaine Dependence: Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo
Pharmacotherapy for Cocaine Dependence - 1

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Cocaine-Related Disorders
Drug: Dextro-Amphetamine Sulfate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
25 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00218348
NIDA-16305-1, R01-16305-1, DPMC
Not Provided
Joy Schmitz, PhD, University of Texas Health Science Center - Houston
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Joy M Schmitz, PhD The University of Texas Health Science Center, Houston
National Institute on Drug Abuse (NIDA)
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP