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A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01416584
First Posted: August 15, 2011
Last Update Posted: December 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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.

Condition Intervention
Opiate Dependence Behavioral: methadone contingency Behavioral: Methadone & Abstinence Contingency

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Percentage of Months in Methadone Treatment [ Time Frame: 6 months ]
    The percentage of months in which participants were enrolled in methadone treatment during the 6-month intervention evaluation period?

  • Percentage of Monthly Urine Sample Negative for Opiates [ Time Frame: 6 months ]
    Percentage of urine sample negative for opiates at each of the six 30-day assessments scheduled throughout the intervention evaluation

  • Percentage of Monthly Urine Samples Negative for Cocaine [ Time Frame: 6 months ]
    Was the participant's urine sample negative for cocaine at each of the six 30-day assessments scheduled throughout the intervention evaluation period?


Secondary Outcome Measures:
  • Percentage of M,W,F Urine Samples Negative for Cocaine [ Time Frame: 6 months ]
    Was each participant's urine sample negative for cocaine at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period?

  • Percentage of M,W,F Urine Samples Negative for Opiates [ Time Frame: 6 months ]
    Was each participant's urine sample negative for opiates at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period?


Other Outcome Measures:
  • Did Participant Share Needles or Works? [ Time Frame: 6 months ]
    Percent of months that participants reported sharing needles or works.

  • Went to Shooting Gallery/House or Other Place Where Users go to Shoot-up? [ Time Frame: 6 months ]
    The percent of months that participants reported going to a shooting gallery/hour or other place where users go to shoot-up.

  • Did Participant Inject Drugs? [ Time Frame: 6 months ]
    Percent of months that participants reported injecting drugs.

  • In Methadone Treatment at End of Treatment [ Time Frame: 6 months ]
    Was each participant in methadone treatment at the end of the 6-month intervention evaluation period?

  • Entered Methadone Treatment [ Time Frame: 6 months ]
    Did the participant enter methadone treatment at any point in the 6-month treatment period?


Enrollment: 98
Study Start Date: October 2008
Study Completion Date: April 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care Control
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.
Experimental: Methadone Contingency Group
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
Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace.
Experimental: Methadone & Abstinence Contingency
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
Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace.
Behavioral: Methadone & Abstinence Contingency
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.

Detailed Description:
A randomized study is planned for 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting methadone treatment and abstinence in unemployed injection drug users. Participants will be recruited through street outreach, at agencies that serve the target populations, and informal word-of-mouth referrals. Participants will be invited to attend the workplace and to enroll in the methadone treatment. To engage participants in the workplace, they will be allowed to work independent of whether they enroll in methadone treatment and independent of their drug use. The workplace participants (N=162) will be randomly assigned to three groups. The "Usual Care Control" participants will be allowed to work independent of their methadone use or urinalysis results. The "Methadone Contingency" participants will be required to take methadone to attend work, and will receive a brief pay decrease for failing to take their medication. The "Methadone & Abstinence Contingency" participants will be required to take their medication in order to attend work, as well as receive a brief pay decrease for any positive urine samples for both cocaine and methadone.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416584


Locations
United States, Maryland
Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Kenneth Silverman, Ph.D. Professor, Johns Hopkins University School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01416584     History of Changes
Other Study ID Numbers: NA_00020746
R01DA023864 ( U.S. NIH Grant/Contract )
First Submitted: August 12, 2011
First Posted: August 15, 2011
Results First Submitted: September 2, 2016
Results First Posted: September 29, 2017
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents