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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth Silverman, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00249457
First received: November 3, 2005
Last updated: September 6, 2016
Last verified: September 2016
  Purpose
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 Intervention
Behavior, Addictive
Cocaine Abuse
Cocaine Dependence
Heroin Dependence
Opioid Dependence
Behavioral: Contingency management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Therapeutic Workplace for Drug Abusers

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Percentage of urine samples at the assessments that were negative for cocaine, opiates, and opiates and cocaine [ Time Frame: every 30 days throughout fourth year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HIV risk behaviors [ Time Frame: every 30 days throughout fourth year ] [ Designated as safety issue: No ]
  • Percentage of participants employed each month [ Time Frame: every 30 days throughout fourth year ] [ Designated as safety issue: No ]
  • Number of days employed each month [ Time Frame: every 30 days throughout fourth year ] [ Designated as safety issue: No ]
  • Percentage of participants to self-report abstinence at all time points [ Time Frame: every 30 days throughout fourth year ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 1996
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249457

Locations
United States, Maryland
The Center for Learning and Health
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Kenneth Silverman, Ph.D. Johns Hopkins University
  More Information

Publications:
Responsible Party: Kenneth Silverman, Ph.D, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00249457     History of Changes
Other Study ID Numbers: NIDA-13107-2 
Study First Received: November 3, 2005
Last Updated: September 6, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No
Plan Description: The data for this study have been published in a peer-reviewed journal.

Keywords provided by Johns Hopkins University:
Behavior Therapy
Cocaine Abuse
Cocaine Dependence
Contingency Management
Heroin Dependence
Methadone
Opioid Dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Opioid-Related Disorders
Heroin Dependence
Behavior, Addictive
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 26, 2016