NCT00249457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 1996

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1996

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

9.3 years

First QC Date

November 3, 2005

Last Update Submit

October 26, 2017

Conditions

Behavior, AddictiveCocaine AbuseCocaine DependenceHeroin DependenceOpioid Dependence

Keywords

Behavior TherapyCocaine AbuseCocaine DependenceContingency ManagementHeroin DependenceMethadoneOpioid Dependence

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

Therapeutic Workplace

EXPERIMENTAL

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

Behavioral: Contingency management

Usual Care Control Group

NO INTERVENTION

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

Interventions

Contingency managementBEHAVIORAL

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.

Therapeutic Workplace

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Learning and Health

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • 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.

    PMID: 25124257RESULT

MeSH Terms

Conditions

Behavior, AddictiveCocaine-Related DisordersHeroin DependenceOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Study Officials

  • Kenneth Silverman, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

October 1, 1996

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

October 30, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

The data for this study have been published in a peer-reviewed journal.

Locations

US(1)