Clinical trial NCT00218348: Treatment of Cocaine Dependence: Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo
Official title: Pharmacotherapy for Cocaine Dependence - 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: Cocaine Abuse
Dextro-Amphetamine Sulfate
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-09-22
Enrollment: 186
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Substance use and retention
Secondary outcomes:
measure: Effectiveness measures, including psycho-social variables, side effects, and self-reported measures
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Joy M Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: