Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8
Recruitment status was: Recruiting
|Cocaine Abuse Opiate Dependence||Drug: Modafinil 200mg Drug: Modafinil 400mg Drug: Citalopram 20mg Drug: Citalopram 40mg Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals|
- Confirmed abstinence from cocaine [ Time Frame: 12 weeks of treatment ]
- Retention [ Time Frame: 12 weeks of treatment ]
- Medication Compliance [ Time Frame: 12 weeks of treatment ]
|Study Start Date:||July 2006|
|Estimated Study Completion Date:||July 2011|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Modafinil 200mg / Methadone Maintenance (1.2mg/kg)
Drug: Modafinil 200mg
10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1/2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
Modafinil 400mg/ Methadone Maintenance (1.2mg/kg)
Drug: Modafinil 400mg
10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
Citalopram 20/ Methadone Maintenance 1.2mg/kg
Drug: Citalopram 20mg
10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
Citalopram 40/ Methadone Maintenance 1.2 mg/kg
Drug: Citalopram 40mg
10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days.
Placebo Comparator: 5
Placebo given to methadone-maintained subjects (1.2mg/kg) for the duration of the 12-week study
Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218036
|Contact: Laura B Madden-Fuentes, B.A.||713-500-2563||Laura.MaddenFuentes@uth.tmc.edu|
|Contact: Ann Garcia, MA||713-500-2804||Ann.D.Garcia@uth.tmc.edu|
|United States, Texas|
|University of Texas Health Science Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Ann Garcia, MA 713-500-2804 Ann.D.Garcia@uth.tmc.edu|
|Principal Investigator: Richard Meisch, MD, PhD|
|Principal Investigator:||Joy M Schmitz, PhD||University of Texas|
|Study Chair:||F. Gerard Moeller, M.D.||University of Texas Medical School at Houston|