Cocaine-Related Disorders
Conditions
Keywords
Cocaine Abuse, Dextro-Amphetamine Sulfate
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.
Interventions
DRUGDextro-Amphetamine Sulfate
Sponsors
National Institute on Drug Abuse (NIDA)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Substance use and retention | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness measures, including psycho-social variables, side effects, and self-reported measures | — |
Countries
United States
Outcome results
None listed