Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 2

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT00249457

Collaborator

(none)

Enrollment

Location

Arms

111

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether long-term exposure to the Therapeutic Workplace intervention could sustain drug abstinence over an extended period of time in heroin- and cocaine-dependent, unemployed, treatment-resistant young mothers.

Condition or Disease	Intervention/Treatment	Phase
Behavior, Addictive Cocaine Abuse Cocaine Dependence Heroin Dependence Opioid Dependence	Behavioral: Contingency management	N/A

Detailed Description

The current study is a continuation of the research into the development and evaluation of a novel treatment designed to address the chronic, persistent nature of drug addiction. This treatment, called the Therapeutic Workplace, integrates abstinence reinforcement contingencies of proven efficacy into a model supported work program. Participants were paid to work or to train in the Therapeutic Workplace but had to provide drug-free urine samples to gain daily access. Forty participants were randomly assigned to a Therapeutic Workplace or usual care control group. Therapeutic Workplace participants could work for about 5 years. This study reports the effects of the intervention over a follow-up period of 8 years after treatment initiation.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Therapeutic Workplace for Drug Abusers

Study Start Date :

Oct 1, 1996

Actual Primary Completion Date :

Jan 1, 2006

Actual Study Completion Date :

Jan 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Therapeutic Workplace Contingency management. Invited to work in the Therapeutic Workplace. Completed monthly assessments.	Behavioral: Contingency management Invited to attend the Therapeutic Workplace 3 hr per day, Monday through Friday. Each day when a participant reported to the workplace, she was required to provide a urine sample. If the sample tested negative for opiates and cocaine, she was allowed to work that day. Participants who gained entrance to the workplace participated in basic skills education and job skills training throughout each 3-hr work shift.
No Intervention: Usual Care Control Group No intervention. Not invited to work int the Therapeutic Workplace. Completed monthly assessments.

Arm

Intervention/Treatment

Experimental: Therapeutic Workplace

Contingency management. Invited to work in the Therapeutic Workplace. Completed monthly assessments.

Behavioral: Contingency management

Invited to attend the Therapeutic Workplace 3 hr per day, Monday through Friday. Each day when a participant reported to the workplace, she was required to provide a urine sample. If the sample tested negative for opiates and cocaine, she was allowed to work that day. Participants who gained entrance to the workplace participated in basic skills education and job skills training throughout each 3-hr work shift.

No Intervention: Usual Care Control Group

No intervention. Not invited to work int the Therapeutic Workplace. Completed monthly assessments.

Outcome Measures

Primary Outcome Measures

Percentage of urine samples at the assessments that were negative for cocaine [every 30 days throughout fourth year]
(total number of monthly urine samples negative for cocaine/total number of possible urine samples) x 100
Percentage of urine samples at the assessments that were negative for opiates [every 30 days throughout fourth year]
(total number of monthly urine samples negative for opiates/total number of possible urine samples) x 100
Percentage of urine samples at the assessments that were negative for cocaine and opiates [every 30 days throughout fourth year]
(total number of monthly urine samples negative for cocaine and opiates/total number of possible urine samples) x 100

Secondary Outcome Measures

HIV risk behaviors [every 30 days throughout fourth year]
Percentage of participants employed each month [every 30 days throughout fourth year]
Number of days employed each month [every 30 days throughout fourth year]
Percentage of participants to self-report abstinence at all time points [every 30 days throughout fourth year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

When originally enrolled in the study, participants were at least 18 years old, unemployed, and methadone maintenance patients of the Center for Addiction and Pregnancy (CAP) who continued to use opiates or cocaine during CAP treatment.