The purpose of this study is to examine the potent cocaine agonist-like medication d-amphetamine (30 mg) in combination with the agonist-like medication modafinil (200 mg), compared to modafinil alone (200 and 400 mg), in single diagnosis individuals.

Condition	Intervention	Phase
Cocaine Abuse Cocaine-Related Disorders	Drug: Modafinil	Phase II

Further Study Details: 

Primary Outcomes: Substance use, retention and medication compliance
Secondary Outcomes: Cocaine craving and medication side effects
Expected Total Enrollment:  200

This is a double-blind, placebo-controlled trial examining two doses of modafinil (200 and 400 mg) comapred to a combined regimen of d-amphetamine (30 mg) and modafinil (200 mg) in cocaine dependent individuals. Participants will be randomly assigned to four groups over a 16-week period. Participants will initially receive modafinil over 4 days at 200 mg and then, if in the 400 mg group, will receive double the initial dose. Participants in the combined group will, over a period of 4 days, receive 15 and 30 mg of d-amphetamine.

Ages Eligible for Study:  22 Years   -   50 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Meets SCID criteria for cocaine abuse or dependence
• In general good physical and psychiatric health, except for possible acute drug-use related problems
• May be HIV positive if in generally good health (unless medication interactions are problematic)

Exclusion Criteria:

• Meets diagnostic criteria for other psychiatric disorders, including other forms of drug dependence, other than nicotine
• Current cardiovascular disease, as determined by an electrocardiogram
• On probation or parole if the circumstances do not allow study completion or if ethical constraints of supervision do not allow confidentiality
• Previously received treatment with d-amphetamine, modafinil, or aripiprazole
• Currently receiving prescribed medication

Please refer to this study by ClinicalTrials.gov identifier  NCT00218062

Ayesha Chawdhary, B.A.      (713)500-2820    ayesha.chawdhary@uth.tmc.edu

Texas
      University of Texas Health Science Center, San Antonio,  Texas,  78284,  United States

Study chairs or principal investigators

John Grabowski, Ph.D.,  Principal Investigator,  University of Texas   

Study ID Numbers:  NIDA-09262-12; P50-09262-12
Last Updated:  September 21, 2005
Record first received:  September 16, 2005
ClinicalTrials.gov Identifier:  NCT00218062
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-27