Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

Phase 2

Terminated

• Conditions: Cocaine Abuse; Opiate Dependence
• Interventions: Drug: Placebo; Drug: Modafinil 200mg; Drug: Citalopram 40mg; Drug: Modafinil 400mg; Drug: Citalopram 20mg

• Registration Number: NCT00218036
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Study Timeline

• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Study Start: 2006-07
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Results First Submitted: 2018-05-01
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-19
• Last Update Submitted: 2018-10-19
• Results First Posted: 2018-11-16
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5	Placebo	Placebo given to methadone-maintained subjects (1.2mg/kg) for the duration of the 12-week study
1	Modafinil 200mg	Modafinil 200mg / Methadone Maintenance (1.2mg/kg)
4	Citalopram 40mg	Citalopram 40/ Methadone Maintenance 1.2 mg/kg
2	Modafinil 400mg	Modafinil 400mg/ Methadone Maintenance (1.2mg/kg)
3	Citalopram 20mg	Citalopram 20/ Methadone Maintenance 1.2mg/kg

Primary Outcome Measures

Name	Time	Method
Confirmed Abstinence From Cocaine	12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Retention	12 weeks of treatment
Medication Compliance	12 weeks of treatment

Trial Locations

Locations (1)

University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States