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

Study Overview
=================
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.

Official Title
-----------------
Pharmacotherapy for Cocaine Dependence - 1

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Dextro-Amphetamine Sulfate


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dextro-Amphetamine Sulfate|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance use and retention |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness measures, including psycho-social variables, side effects, and self-reported measures |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cocaine Abuse, Dextro-Amphetamine Sulfate