Opiate Dependence
Conditions
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.
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.
Interventions
BEHAVIORALmethadone contingency
Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace.
BEHAVIORALMethadone & 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Months in Methadone Treatment | 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 Samples Negative for Cocaine | 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? |
| Percentage of Monthly Urine Sample Negative for Opiates | 6 months | Percentage of urine sample negative for opiates at each of the six 30-day assessments scheduled throughout the intervention evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of M,W,F Urine Samples Negative for Cocaine | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Did Participant Inject Drugs? | 6 months | Percent of months that participants reported injecting drugs. |
| In Methadone Treatment at End of Treatment | 6 months | Was each participant in methadone treatment at the end of the 6-month intervention evaluation period? |
| Did Participant Share Needles or Works? | 6 months | Percent of months that participants reported sharing needles or works. |
| Entered Methadone Treatment | 6 months | Did the participant enter methadone treatment at any point in the 6-month treatment period? |
| Went to Shooting Gallery/House or Other Place Where Users go to Shoot-up? | 6 months | The percent of months that participants reported going to a shooting gallery/hour or other place where users go to shoot-up. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 35 |
| 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. | 33 |
| Total | 98 |
Baseline characteristics
| Characteristic | Methadone Contingency Group | Methadone & Abstinence Contingency | Usual Care Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 33 Participants | 30 Participants | 97 Participants |
| Age, Continuous | 42 years STANDARD_DEVIATION 10 | 44 years STANDARD_DEVIATION 9 | 44 years STANDARD_DEVIATION 9 | 44 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 35 participants | 33 participants | 30 participants | 98 participants |
| Sex: Female, Male Female | 8 Participants | 15 Participants | 10 Participants | 33 Participants |
| Sex: Female, Male Male | 27 Participants | 18 Participants | 20 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 1 / 35 | 0 / 33 |
| serious Total, serious adverse events | 1 / 30 | 0 / 35 | 1 / 33 |
Outcome results
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
Time frame: 6 months
Population: Intent to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care Control | Percentage of Monthly Urine Sample Negative for Opiates | 54 percentage of opiate negative |
| Methadone Contingency Group | Percentage of Monthly Urine Sample Negative for Opiates | 61 percentage of opiate negative |
| Methadone & Abstinence Contingency | Percentage of Monthly Urine Sample Negative for Opiates | 75 percentage of opiate negative |
p-value: 0.0295% CI: [0.38, 0.41]General Estimating Equation (GEE)
p-value: 0.3995% CI: [0.34, 1.57]General Estimating Equation (GEE)
p-value: 0.195% CI: [1.53, 2.26]General Estimating Equation (GEE)
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?
Time frame: 6 months
Population: intent to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care Control | Percentage of Monthly Urine Samples Negative for Cocaine | 32 percentage of cocaine negative |
| Methadone Contingency Group | Percentage of Monthly Urine Samples Negative for Cocaine | 55 percentage of cocaine negative |
| Methadone & Abstinence Contingency | Percentage of Monthly Urine Samples Negative for Cocaine | 57 percentage of cocaine negative |
p-value: 0.0295% CI: [0.36, 0.38]General Estimating Equation (GEE)
p-value: 0.0295% CI: [0.38, 0.41]General Estimating Equation (GEE)
p-value: 0.8595% CI: [0.2, 5.66]General Estimating Equation (GEE)
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?
Time frame: 6 months
Population: Intent to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care Control | Percentage of Months in Methadone Treatment | 81 percent of months in methadone treatment |
| Methadone Contingency Group | Percentage of Months in Methadone Treatment | 82 percent of months in methadone treatment |
| Methadone & Abstinence Contingency | Percentage of Months in Methadone Treatment | 88 percent of months in methadone treatment |
p-value: 0.695% CI: [0.4, 4.83]General Estimating Equation (GEE)
p-value: 0.8895% CI: [0.32, 3.73]General Estimating Equation (GEE)
p-value: 0.6495% CI: [0.36, 4.46]General Estimating Equation (GEE)
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?
Time frame: 6 months
Population: intent to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care Control | Percentage of M,W,F Urine Samples Negative for Cocaine | 25 percentage of urine samples |
| Methadone Contingency Group | Percentage of M,W,F Urine Samples Negative for Cocaine | 44 percentage of urine samples |
| Methadone & Abstinence Contingency | Percentage of M,W,F Urine Samples Negative for Cocaine | 48 percentage of urine samples |
p-value: 0.0195% CI: [0.34, 0.35]General Estimating Equation (GEE)
p-value: 0.0395% CI: [0.39, 0.44]General Estimating Equation (GEE)
p-value: 0.6395% CI: [0.42, 1.69]General Estimating Equation (GEE)
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?
Time frame: 6 months
Population: intent to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care Control | Percentage of M,W,F Urine Samples Negative for Opiates | 43 percentage of M,W,F urine samples |
| Methadone Contingency Group | Percentage of M,W,F Urine Samples Negative for Opiates | 50 percentage of M,W,F urine samples |
| Methadone & Abstinence Contingency | Percentage of M,W,F Urine Samples Negative for Opiates | 65 percentage of M,W,F urine samples |
p-value: 0.0195% CI: [0.39, 0.4]General Estimating Equation (GEE)
p-value: 0.3795% CI: [0.36, 1.55]General Estimating Equation (GEE)
p-value: 0.0595% CI: [0.28, 1]General Estimating Equation (GEE)
Other Pre-specified
Did Participant Inject Drugs?
Percent of months that participants reported injecting drugs.
Time frame: 6 months
Population: We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.
Other Pre-specified
Did Participant Share Needles or Works?
Percent of months that participants reported sharing needles or works.
Time frame: 6 months
Population: 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.
Other Pre-specified
Entered Methadone Treatment
Did the participant enter methadone treatment at any point in the 6-month treatment period?
Time frame: 6 months
Population: We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.
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?
Time frame: 6 months
Population: We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.
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.
Time frame: 6 months
Population: 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.