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

Study Overview
=================
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.

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.

Official Title
-----------------
A Therapeutic Workplace for Drug Abusers

Conditions
-----------------
Behavior, Addictive, Cocaine Abuse, Cocaine Dependence, Heroin Dependence, Opioid Dependence

Intervention / Treatment
-----------------
* Behavioral: Contingency management


Participation Criteria
=================
Eligibility Criteria
-----------------
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. Exclusion Criteria: Participants were excluded if they were at risk for suicide at the time of intake or if they had serious psychiatric illness (e.g., schizophrenia).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Workplace<br>Contingency management. Invited to work in the Therapeutic Workplace. Completed monthly assessments. | Behavioral: Contingency management<br>* 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.<br>|
| No Intervention: Usual Care Control Group<br>No intervention. Not invited to work int the Therapeutic Workplace. Completed monthly assessments. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of urine samples at the assessments that were negative for cocaine | (total number of monthly urine samples negative for cocaine/total number of possible urine samples) x 100 | every 30 days throughout fourth year | 
| Percentage of urine samples at the assessments that were negative for opiates | (total number of monthly urine samples negative for opiates/total number of possible urine samples) x 100 | every 30 days throughout fourth year | 
| Percentage of urine samples at the assessments that were negative for cocaine and opiates | (total number of monthly urine samples negative for cocaine and opiates/total number of possible urine samples) x 100 | every 30 days throughout fourth year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Behavior Therapy, Cocaine Abuse, Cocaine Dependence, Contingency Management, Heroin Dependence, Methadone, Opioid Dependence