Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

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.

Conditions

• Cocaine Abuse
• Opiate Dependence

Interventions

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• University of Texas

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• Joy M Schmitz, PhD · University of Texas

• F. Gerard Moeller, M.D. · University of Texas Medical School at Houston

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

22 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-07-31

Primary Completion

2010-02-28

Completion

2010-02-28

Countries

• United States

Study Locations