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

Primary Purpose

Behavior, Addictive, Cocaine Abuse, Cocaine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency management
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behavior, Addictive focused on measuring Behavior Therapy, Cocaine Abuse, Cocaine Dependence, Contingency Management, Heroin Dependence, Methadone, Opioid Dependence

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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. 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).

Sites / Locations

  • The Center for Learning and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Therapeutic Workplace

Usual Care Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

HIV risk behaviors
Percentage of participants employed each month
Number of days employed each month
Percentage of participants to self-report abstinence at all time points

Full Information

First Posted
November 3, 2005
Last Updated
October 26, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00249457
Brief Title
Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 2
Official Title
A Therapeutic Workplace for Drug Abusers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 1996 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior, Addictive, Cocaine Abuse, Cocaine Dependence, Heroin Dependence, Opioid Dependence
Keywords
Behavior Therapy, Cocaine Abuse, Cocaine Dependence, Contingency Management, Heroin Dependence, Methadone, Opioid Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Workplace
Arm Type
Experimental
Arm Description
Contingency management. Invited to work in the Therapeutic Workplace. Completed monthly assessments.
Arm Title
Usual Care Control Group
Arm Type
No Intervention
Arm Description
No intervention. Not invited to work int the Therapeutic Workplace. Completed monthly assessments.
Intervention Type
Behavioral
Intervention Name(s)
Contingency management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of urine samples at the assessments that were negative for cocaine
Description
(total number of monthly urine samples negative for cocaine/total number of possible urine samples) x 100
Time Frame
every 30 days throughout fourth year
Title
Percentage of urine samples at the assessments that were negative for opiates
Description
(total number of monthly urine samples negative for opiates/total number of possible urine samples) x 100
Time Frame
every 30 days throughout fourth year
Title
Percentage of urine samples at the assessments that were negative for cocaine and opiates
Description
(total number of monthly urine samples negative for cocaine and opiates/total number of possible urine samples) x 100
Time Frame
every 30 days throughout fourth year
Secondary Outcome Measure Information:
Title
HIV risk behaviors
Time Frame
every 30 days throughout fourth year
Title
Percentage of participants employed each month
Time Frame
every 30 days throughout fourth year
Title
Number of days employed each month
Time Frame
every 30 days throughout fourth year
Title
Percentage of participants to self-report abstinence at all time points
Time Frame
every 30 days throughout fourth year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Silverman, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Learning and Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data for this study have been published in a peer-reviewed journal.
Citations:
PubMed Identifier
25124257
Citation
Aklin WM, Wong CJ, Hampton J, Svikis DS, Stitzer ML, Bigelow GE, Silverman K. A therapeutic workplace for the long-term treatment of drug addiction and unemployment: eight-year outcomes of a social business intervention. J Subst Abuse Treat. 2014 Nov-Dec;47(5):329-38. doi: 10.1016/j.jsat.2014.06.013. Epub 2014 Jul 12.
Results Reference
result

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

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