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Completed

NCT Number: NCT01416584

A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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?

  2. 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

  3. 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 outcomes

  1. 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?

  2. 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 outcomes

  1. Did Participant Share Needles or Works?

    Time frame: 6 months

    Percent of months that participants reported sharing needles or works.

  2. 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.

  3. Did Participant Inject Drugs?

    Time frame: 6 months

    Percent of months that participants reported injecting drugs.

  4. 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?

  5. Entered Methadone Treatment

    Time frame: 6 months

    Did the participant enter methadone treatment at any point in the 6-month treatment period?

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Aug 15, 2011
Registry last updated
Dec 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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