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Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00218348


Primary Contact:

Principal Investigator
Joy M Schmitz, PhD
The University of Texas Health Science Center, Houston


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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