Vouchers vs. Prizes for Cocaine-Dependent Methadone Patients - 2 - Clinical Trial for Cocaine Dependence | NCT00249535

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Contingency management

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring Substance Abuse, Contingency Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: age > 18 years current DSM-IV diagnosis of cocaine dependence received methadone treatment at the clinic for at least 3 months on a stable dose of methadone (no changes in dosing) for at least one month and not presently requesting a dose alteration submitted one or more clinic-collected cocaine positive urine samples in the previous 3 months English speaking pass a brief quiz related to understanding of the informed consent form Exclusion criteria: have a serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) have dementia (<23 on the Mini Mental State Exam; Folstein et al. 1975) are in recovery from pathological gambling

Sites / Locations

UConn Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

1

2

3

Arm Description

standard treatment plus usual magnitude prize CM

standard treatment plus higher magnitude prize CM

standard treatment plus voucher CM

Outcomes

Primary Outcome Measures

Cocaine use

Secondary Outcome Measures

Full Information

NCT ID

NCT00249535

First Posted

November 3, 2005

Last Updated

March 29, 2012

Sponsor

UConn Health

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00249535

Brief Title

Vouchers vs. Prizes for Cocaine-Dependent Methadone Patients - 2

Official Title

Vouchers vs. Prizes for Cocaine-Dependent Methadone Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UConn Health

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this study is to compare voucher-based contingency management (CM) procedures to a lower-cost CM system that provides opportunities to win prizes. Cocaine-dependent outpatients are randomly assigned to (a) standard treatment, (b) standard treatment plus usual magnitude prize CM, (c) standard treatment plus higher magnitude prize CM, or (d) standard treatment plus voucher CM. Urine and breath samples are collected 2-3x/week for 14 weeks. Follow-up interviews are conducted at 1,3,6 and 9 months following intake during which substance use and psychosocial functioning are assessed.

6. Conditions and Keywords

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

Cocaine Dependence

Keywords

Substance Abuse, Contingency Management

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

240 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Description

standard treatment plus usual magnitude prize CM

Arm Title

2

Arm Type

Experimental

Arm Description

standard treatment plus higher magnitude prize CM

Arm Title

3

Arm Type

Experimental

Arm Description

standard treatment plus voucher CM

Intervention Type

Behavioral

Intervention Name(s)

Contingency management

Intervention Description

Rewards (prizes) for abstinence

Primary Outcome Measure Information:

Title

Cocaine use

Time Frame

baseline and each follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion criteria: age > 18 years current DSM-IV diagnosis of cocaine dependence received methadone treatment at the clinic for at least 3 months on a stable dose of methadone (no changes in dosing) for at least one month and not presently requesting a dose alteration submitted one or more clinic-collected cocaine positive urine samples in the previous 3 months English speaking pass a brief quiz related to understanding of the informed consent form Exclusion criteria: have a serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) have dementia (<23 on the Mini Mental State Exam; Folstein et al. 1975) are in recovery from pathological gambling

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nancy Petry, Ph.D.

Organizational Affiliation

UConn Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

UConn Health Center

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030

Country

United States

Vouchers vs. Prizes for Cocaine-Dependent Methadone Patients - 2

Cocaine Dependence

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial