Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

The University of Texas System (UT)

Status and phase: Terminated; Phase 2

Conditions: Opiate Dependence; Cocaine Abuse

Treatments: Drug: Modafinil 400mg; Drug: Placebo; Drug: Citalopram 20mg; Drug: Modafinil 200mg; Drug: Citalopram 40mg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00218036

P50DA009262-08 (U.S. NIH Grant/Contract)

NIDA-09262-8

DPMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 22 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

Modafinil 200mg / Methadone Maintenance (1.2mg/kg)

Treatment:

Drug: Modafinil 200mg

2

Experimental group

Description:

Modafinil 400mg/ Methadone Maintenance (1.2mg/kg)

Treatment:

Drug: Modafinil 400mg

3

Experimental group

Description:

Citalopram 20/ Methadone Maintenance 1.2mg/kg

Treatment:

Drug: Citalopram 20mg

4

Experimental group

Description:

Citalopram 40/ Methadone Maintenance 1.2 mg/kg

Treatment:

Drug: Citalopram 40mg

5

Placebo Comparator group

Description:

Placebo given to methadone-maintained subjects (1.2mg/kg) for the duration of the 12-week study

Treatment:

Drug: Placebo