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Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

Primary Purpose

Cocaine Abuse, Opiate Dependence

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Modafinil 200mg

Modafinil 400mg

Citalopram 20mg

Citalopram 40mg

Placebo

About this trial

This is an interventional treatment trial for Cocaine Abuse focused on measuring Cocaine Abuse, Opiate Abuse

Eligibility Criteria

22 Years - 50 Years (Adult)All SexesAccepts 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)

Sites / Locations

University of Texas Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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

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

Citalopram 20/ Methadone Maintenance 1.2mg/kg

Citalopram 40/ Methadone Maintenance 1.2 mg/kg

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

Outcomes

Primary Outcome Measures

Confirmed Abstinence From Cocaine

Secondary Outcome Measures

Retention

Medication Compliance

Full Information

NCT ID

NCT00218036

First Posted

September 16, 2005

Last Updated

October 19, 2018

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute on Drug Abuse (NIDA), University of Texas

1. Study Identification

Unique Protocol Identification Number

NCT00218036

Brief Title

Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

Official Title

Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Terminated

Why Stopped

PI left institution, end of funding, clinic relocation, recruitment issues

Study Start Date

July 2006 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute on Drug Abuse (NIDA), University of Texas

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Abuse, Opiate Dependence

Keywords

Cocaine Abuse, Opiate Abuse

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

Citalopram 20/ Methadone Maintenance 1.2mg/kg

Arm Title

Arm Type

Experimental

Arm Description

Citalopram 40/ Methadone Maintenance 1.2 mg/kg

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Modafinil 200mg

Intervention Description

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

Intervention Name(s)

Modafinil 400mg

Intervention Description

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

Intervention Name(s)

Citalopram 20mg

Intervention Description

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

Intervention Name(s)

Citalopram 40mg

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Confirmed Abstinence From Cocaine

Time Frame

12 weeks of treatment

Secondary Outcome Measure Information:

Title

Retention

Time Frame

12 weeks of treatment

Title

Medication Compliance

Time Frame

12 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joy M Schmitz, PhD

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

F. Gerard Moeller, M.D.

Organizational Affiliation

University of Texas Medical School at Houston

Official's Role

Study Chair

Facility Information:

Facility Name

University of Texas Health Science Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

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Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

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