Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 2
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ClinicalTrials.gov Identifier: NCT00249457 |
Recruitment Status
:
Completed
First Posted
: November 7, 2005
Last Update Posted
: October 30, 2017
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Sponsor:
Johns Hopkins University
Information provided by (Responsible Party):
Johns Hopkins University
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE |
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 |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE |
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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. |
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Study Arms |
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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. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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Responsible Party | Johns Hopkins University | ||||
Study Sponsor ICMJE | Johns Hopkins University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |