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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA023864 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methadone contingency | Behavioral | Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of M,W,F Urine Samples Negative for Cocaine | Was each participant's urine sample negative for cocaine at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period? | 6 months |
| Percentage of M,W,F Urine Samples Negative for Opiates |
| Measure | Description | Time Frame |
|---|---|---|
| Did Participant Share Needles or Works? | Percent of months that participants reported sharing needles or works. | 6 months |
| Went to Shooting Gallery/House or Other Place Where Users go to Shoot-up? | The percent of months that participants reported going to a shooting gallery/hour or other place where users go to shoot-up. |
Individuals were eligible if they were:
Participants were excluded if they
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
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Silverman, Ph.D. | Professor, Johns Hopkins University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142 | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24607365 | Derived | 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. |
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Eligible participants were invited to participate in a 4-week induction. During induction, participants were invited to attend the therapeutic workplace. 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.
Participants were recruited through agencies that served the target population, street outreach, and a respondent-driven sampling referral system in which study participants were paid for successfully referring others to the study. Interested individuals completed a brief screening interview that gauged study eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 are not required to join in order to gain access to the workplace. |
| FG001 | 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. |
| FG002 | Methadone & Abstinence Contingency | Participants were be able to access work if they enroll in the methadone treatment and consistently take their medication, but also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care Control | Participants in this group will be offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They will be offered the methadone treatment but are not required to join in order to gain access to the workplace. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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? | Intent to treat | Posted | Mean | Full Range | percent of months in methadone treatment | 6 months |
|
7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care Control | Participants in this group will be offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They will be offered the methadone treatment but are not required to join in order to gain access to the workplace. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for car accident | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Silverman | Johns Hopkins University School of Medicine | 410-550-2694 | ksilverm@jhmi.edu |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| 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. |
|
Was each participant's urine sample negative for opiates at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period? |
| 6 months |
| 6 months |
| Did Participant Inject Drugs? | Percent of months that participants reported injecting drugs. | 6 months |
| In Methadone Treatment at End of Treatment | Was each participant in methadone treatment at the end of the 6-month intervention evaluation period? | 6 months |
| Entered Methadone Treatment | Did the participant enter methadone treatment at any point in the 6-month treatment period? | 6 months |
| Methadone Contingency Group |
Participants in this group will only be allowed to work and earn wages as long as they enroll in the methadone treatment and continue to take does of methadone consistently. |
| BG002 | Methadone & Abstinence Contingency | Participants will only be able to access work if they enroll in the methadone treatment and consistently take their medication, but also will receive a decrease in base pay if they test positive for opiates or cocaine on the drug screens. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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. |
|
|
|
| Primary | 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 | Intent to treat | Posted | Mean | Full Range | percentage of opiate negative | 6 months |
|
|
|
|
| Primary | 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? | intent to treat | Posted | Mean | Full Range | percentage of cocaine negative | 6 months |
|
|
|
|
| Secondary | Percentage of M,W,F Urine Samples Negative for Cocaine | Was each participant's urine sample negative for cocaine at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period? | intent to treat | Posted | Mean | Full Range | percentage of urine samples | 6 months |
|
|
|
|
| Secondary | Percentage of M,W,F Urine Samples Negative for Opiates | Was each participant's urine sample negative for opiates at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period? | intent to treat | Posted | Mean | Full Range | percentage of M,W,F urine samples | 6 months |
|
|
|
|
| Other Pre-specified | Did Participant Share Needles or Works? | Percent of months that participants reported sharing needles or works. | Due to the very low rate of reports of sharing needles or works in all groups, we did not analyze this measure. This grant has ended and there is no funding to conduct more analyses. | Posted | 6 months |
|
|
| Other Pre-specified | Went to Shooting Gallery/House or Other Place Where Users go to Shoot-up? | The percent of months that participants reported going to a shooting gallery/hour or other place where users go to shoot-up. | Due to the very low rate of reports of going to a shooting gallery/house or other place where users go to shoot-up in all groups, we did not analyze this measure. This grant has ended and there is no funding to conduct more analyses. | Posted | 6 months |
|
|
| Other Pre-specified | Did Participant Inject Drugs? | Percent of months that participants reported injecting drugs. | We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses. | Posted | 6 months |
|
|
| Other Pre-specified | In Methadone Treatment at End of Treatment | Was each participant in methadone treatment at the end of the 6-month intervention evaluation period? | We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses. | Posted | 6 months |
|
|
| Other Pre-specified | Entered Methadone Treatment | Did the participant enter methadone treatment at any point in the 6-month treatment period? | We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses. | Posted | 6 months |
|
|
| 1 |
| 30 |
| 0 |
| 30 |
| EG001 | Methadone Contingency Group | Participants in this group will only be allowed to work and earn wages as long as they enroll in the methadone treatment and continue to take does of methadone consistently. | 0 | 35 | 1 | 35 |
| EG002 | Methadone & Abstinence Contingency | Participants will only be able to access work if they enroll in the methadone treatment and consistently take their medication, but also will receive a decrease in base pay if they test positive for opiates or cocaine on the drug screens. | 1 | 33 | 0 | 33 |
| Hospitalization for Vaginal Swelling | Reproductive system and breast disorders | Systematic Assessment |
|
| Inpatient heroin detoxification | General disorders | Systematic Assessment |
|
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| Odds Ratio (OR) |
| 0.73 |
| 2-Sided |
| 95 |
| 0.34 |
| 1.57 |
| Superiority |
| General Estimating Equation (GEE) | 0.10 | Odds Ratio (OR) | 1.86 | 2-Sided | 95 | 1.53 | 2.26 | Superiority |
| Odds Ratio (OR) |
| 0.39 |
| 2-Sided |
| 95 |
| 0.38 |
| 0.41 |
| Superiority |
| General Estimating Equation (GEE) | 0.85 | Odds Ratio (OR) | 1.07 | 2-Sided | 95 | 0.20 | 5.66 | Superiority |
| Odds Ratio (OR) |
| 0.41 |
| 2-Sided |
| 95 |
| 0.39 |
| 0.44 |
| Superiority |
| General Estimating Equation (GEE) | 0.63 | Odds Ratio (OR) | 0.84 | 2-Sided | 95 | 0.42 | 1.69 | Superiority |
| Odds Ratio (OR) |
| 0.75 |
| 2-Sided |
| 95 |
| 0.36 |
| 1.55 |
| Superiority or Other |
| General Estimating Equation (GEE) | 0.05 | Odds Ratio (OR) | 0.53 | 2-Sided | 95 | 0.28 | 1.00 | Superiority |