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

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.

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