NCT00218036

Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 22 Years – 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Cocaine Abuse
• Opiate Dependence

Interventions

Type	Name	Description
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.
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.
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.
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.
DRUG	Placebo	Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg

Timeline

• Start date: 2006-07-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2005-09-22
• Last updated: 2018-11-16
• Results posted: 2018-11-16

Locations

1 site across 1 country: United States