A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment

NCT01416584 | Completed Results

• 2 other identifiers: NA_00020746R01DA023864
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of the Therapeutic Workplace in promoting methadone treatment and increasing abstinence in unemployed, out-of-treatment injection heroine users.

Conditions

Opiate Dependence

Outcome Measures

Primary Outcomes (3)

• Percentage of Months in Methadone Treatment

  The percentage of months in which participants were enrolled in methadone treatment during the 6-month intervention evaluation period?

  6 months

• Percentage of Monthly Urine Sample Negative for Opiates

  Percentage of urine sample negative for opiates at each of the six 30-day assessments scheduled throughout the intervention evaluation

  6 months

• Percentage of Monthly Urine Samples Negative for Cocaine

  Was the participant's urine sample negative for cocaine at each of the six 30-day assessments scheduled throughout the intervention evaluation period?

  6 months

Secondary Outcomes (2)

• Percentage of M,W,F Urine Samples Negative for Cocaine

  6 months

• Percentage of M,W,F Urine Samples Negative for Opiates

  6 months

Other Outcomes (5)

• Did Participant Share Needles or Works?

  6 months

• Went to Shooting Gallery/House or Other Place Where Users go to Shoot-up?

  6 months

• Did Participant Inject Drugs?

  6 months

Study Arms (3)

Usual Care Control

NO INTERVENTION

Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace.

Methadone Contingency Group

EXPERIMENTAL

Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently (employment-based reinforcement).

Behavioral: methadone contingency

Methadone & Abstinence Contingency

EXPERIMENTAL

Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens (employment-based reinforcement).

Behavioral: methadone contingency; Behavioral: Methadone & Abstinence Contingency

Interventions

methadone contingency BEHAVIORAL

Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace.

Methadone & Abstinence Contingency; Methadone Contingency Group

Methadone & Abstinence Contingency BEHAVIORAL

Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace and they had to provide opiate and cocaine negative urine samples to maintain the maximum pay.

Methadone & Abstinence Contingency

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Individuals were eligible if they were: * at least 18 years old, * reported injection drug use in the past 30 days, * met the Diagnostic and Statistical Manual (DSM)-IV criteria for opioid dependence, * reported using heroin at least 21 out of the past 30 days, * provided an opiate-positive urine sample, * showed visible signs of injection drug use (i.e., track marks), * reported not receiving substance abuse treatment in the past 30 days, * lived in Baltimore, * and were unemployed. Participants were excluded if they * had current severe psychiatric disorders or chronic medical conditions that would interfere with their ability to participate in the workplace, * reported current suicidal or homicidal ideation, * had physical limitations that would prevent them from using a keyboard, * had medical insurance coverage (as this would disqualify them from receiving interim methadone treatment), * were pregnant or breastfeeding, * or were currently considered a prisoner. Eligible participants were invited to participate in a 4-week induction. Participants who attended the workplace for at least five minutes on two out of five workdays in the last week of induction were randomly assigned to one of three conditions and were invited to attend the workplace for an additional 26 weeks

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Holtyn AF, Koffarnus MN, DeFulio A, Sigurdsson SO, Strain EC, Schwartz RP, Leoutsakos JM, Silverman K. The therapeutic workplace to promote treatment engagement and drug abstinence in out-of-treatment injection drug users: a randomized controlled trial. Prev Med. 2014 Nov;68:62-70. doi: 10.1016/j.ypmed.2014.02.021. Epub 2014 Mar 4.

  PMID: 24607365 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Methadone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Results Point of Contact

• Title: Kenneth Silverman
• Organization: Johns Hopkins University School of Medicine

ksilverm@jhmi.edu

410-550-2694

Study Officials

• Kenneth Silverman, Ph.D.

  Professor, Johns Hopkins University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: August 12, 2011
• First Posted: August 15, 2011
• Study Start: October 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: April 1, 2014
• Last Updated: December 5, 2017
• Results First Posted: September 29, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)