Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

NCT ID: NCT00218036

Last Updated: 2018-11-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2010-02-28

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.

Conditions

Cocaine Abuse; Opiate Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

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

Group Type: EXPERIMENTAL

Modafinil 200mg

Intervention Type: DRUG

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.

2

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

Group Type: EXPERIMENTAL

Modafinil 400mg

Intervention Type: DRUG

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.

3

Citalopram 20/ Methadone Maintenance 1.2mg/kg

Group Type: EXPERIMENTAL

Citalopram 20mg

Intervention Type: DRUG

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.

4

Citalopram 40/ Methadone Maintenance 1.2 mg/kg

Group Type: EXPERIMENTAL

Citalopram 40mg

Intervention Type: DRUG

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.

5

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Placebo

Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Texas

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Joy Schmitz

Professor - Psy, Behavioral Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joy M Schmitz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

F. Gerard Moeller, M.D.

Role: STUDY_CHAIR

University of Texas Medical School at Houston

Locations

University of Texas Health Science Center

Houston, Texas, United States

Countries

United States

Other Identifiers

P50DA009262-08

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DPMC

Identifier Type: OTHER

Identifier Source: secondary_id

NIDA-09262-8

Identifier Type: -

Identifier Source: org_study_id