Effectiveness of Modafinil and D-Amphetamine in Treating Cocaine Dependent Individuals

Condition(s) targeted: Cocaine-Related Disorders

Intervention: Dextro amphetamine sulfate and Modafinil (Drug); modafinil (Drug); Modafinil 400 mg (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Joy M. Schmitz, PhD, Principal Investigator, Affiliation: University of Texas

Overall contact:
Jan Lindsay, Ph.D., Phone: 713-500-2563, Email: jan.a.lindsay@uth.tmc.edu

Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effects of d-amphetamine and modafinil, when given alone and in combination, in treating cocaine dependent individuals.

Official title: Pharmacotherapy Dosing Regimen (Cocaine Dependence Population)

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Substance use

Secondary outcome:

Medication compliance

medication side effects

Detailed description: Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Modafinil is a glutamate-enhancing agent. D-amphetamine is a central nervous system stimulant that is approved to treat individuals with narcolepsy and attention deficit disorder. Both modafinil and d-amphetamine may be effective treatments for cocaine dependence. The purpose of this study is to examine the effectiveness of modafinil and d-amphetamine, alone and in combination, in treating cocaine dependent individuals.

This study will last 16 weeks. Participants will be randomly assigned to one of four groups: 1) 200 mg dose of modafinil; 2) 400 mg dose of modafinil; 3) 30 mg dose of d-amphetamine combined with 200 mg dose of modafinil; and 4) placebo. All participants will receive 200 mg of modafinil over 4 days. Participants assigned to the 400 mg modafinil treatment group will then receive double the initial dose of modafinil for the duration of the study. Participants in the combined group (modafinil and d-amphetamine) will receive 15 and then 30 mg of d-amphetamine over 4 days.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Meets SCID criteria for cocaine abuse or dependence

- In general good health. Individuals who are HIV-positive will not be excluded if in

good general health, unless medication interactions exist.

Exclusion Criteria:

- Meets diagnostic criteria for 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

Jan Lindsay, Ph.D., Phone: 713-500-2563, Email: jan.a.lindsay@uth.tmc.edu

University of Texas Health Science Center, Houston, Texas 77030, United States; Recruiting
Ann Garcia, MA, Phone: 713-500-2804, Email: Ann.D.Garcia@uth.tmc.edu

Click here for more information about the Treatment Research Clinic at the University of Texas Health Center at Houston

Starting date: March 2006
Ending date: July 2012
Last updated: August 6, 2008