Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine Abuse; Opiate Dependence
Intervention: Modafinil 200mg (Drug); Modafinil 400mg (Drug); Citalopram 20mg (Drug); Citalopram 40mg (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
F. Gerard Moeller, M.D., Study Chair, Affiliation: University of Texas Medical School at Houston
Overall contact:
Jan Lindsay, Ph.D, Phone: 713-500-2563, Email: jan.a.lindsay@uth.tmc.edu
Summary
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.
Clinical Details
Official title: Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Confirmed abstinence from cocaine
Secondary outcome: RetentionMedication Compliance
Detailed description:
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.
Eligibility
Minimum age: 22 Years.
Maximum age: 50 Years.
Gender(s): Both.
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)
Locations and Contacts
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
Richard Meisch, MD, PhD, Principal Investigator
Additional Information
Click here for the Treatment Research Clinic website
Starting date: July 2006
Ending date: July 2011
Last updated: August 7, 2008
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