Houston, Texas 77030


Purpose:

The purpose of this study is to examine two medications, modafinil and citalopram, in the treatment of cocaine dependent individuals who are maintained on methadone.


Study summary:

This is a 24-week, randomized, double-blind, placebo-controlled study examining two doses of modafinil (200 and 400 mg) and citalopram (20 and 40 mg) in the treatment of methadone maintained cocaine dependent individuals. Participants will first be given methadone to determine its tolerated and effective doses. Most participants will be able to reach a stable dose of methadone within 7 to 10 days of methadone initiation. When 80% of the projected dose of methadone has been achieved, participants will begin the medication regimen of modafinil or citalopram. Modafinil will be given over a 7-day period. Dosing of modafinil will begin at 200 mg and, depending on the individual, may increase to 400 mg. Citalopram will be given in increasing doses, starting at 20 mg and increasing to 40mg.


Criteria:

Inclusion Criteria: - Meets cocaine abuse and dependence criteria (as determined by the SCID) - Meets opiate dependence criteria (as determined by the SCID) - In good general physical and psychiatric health (except for possible acute drug use related problems) 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) - Circumstances will not allow for completion of study (on probation or parole) - Ethical constraints of supervision do not allow confidentiality (on probation or parole)


NCT ID:

NCT00218036


Primary Contact:

Principal Investigator
Joy M Schmitz, PhD
University of Texas

Laura B Madden-Fuentes, B.A.
Phone: 713-500-2563
Email: Laura.MaddenFuentes@uth.tmc.edu


Backup Contact:

Email: Ann.D.Garcia@uth.tmc.edu
Ann Garcia, MA
Phone: 713-500-2804


Location Contact:

Houston, Texas 77030
United States

Ann Garcia, MA
Phone: 713-500-2804
Email: Ann.D.Garcia@uth.tmc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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