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

Tracking Information
First Submitted Date ICMJE	November 3, 2005
First Posted Date ICMJE	November 7, 2005
Last Update Posted Date	October 30, 2017
Study Start Date ICMJE	October 1996
Actual Primary Completion Date	January 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 26, 2017)	Percentage of urine samples at the assessments that were negative for cocaine [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome Measures ICMJE; (submitted: November 3, 2005)	Percentage of urine samples at the assessments that were negative for cocaine, opiates, and opiates and cocaine
Change History	Complete list of historical versions of study NCT00249457 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 6, 2016)	HIV risk behaviors [ Time Frame: every 30 days throughout fourth year ]; Percentage of participants employed each month [ Time Frame: every 30 days throughout fourth year ]; Number of days employed each month [ Time Frame: every 30 days throughout fourth year ]; Percentage of participants to self-report abstinence at all time points [ Time Frame: every 30 days throughout fourth year ]
Original Secondary Outcome Measures ICMJE; (submitted: November 3, 2005)	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
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 2
Official Title ICMJE	A Therapeutic Workplace for Drug Abusers
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Behavior, Addictive; Cocaine Abuse; Cocaine Dependence; Heroin Dependence; Opioid Dependence
Intervention ICMJE	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.
Study Arms	Experimental: Therapeutic Workplace Contingency management. Invited to work in the Therapeutic Workplace. Completed monthly assessments. Intervention: Behavioral: Contingency management; No Intervention: Usual Care Control Group No intervention. Not invited to work int the Therapeutic Workplace. Completed monthly assessments.
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 3, 2005)	40
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	January 2006
Actual Primary Completion Date	January 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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).
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years to 50 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00249457
Other Study ID Numbers ICMJE	NIDA-13107-2
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: No Plan Description: The data for this study have been published in a peer-reviewed journal.
Responsible Party	Johns Hopkins University
Study Sponsor ICMJE	Johns Hopkins University
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Kenneth Silverman, Ph.D. Johns Hopkins University
PRS Account	Johns Hopkins University
Verification Date	October 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP