Opiate Dependence
Conditions
Brief summary
The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.
Detailed description
A randomized study is planned to evaluate the effectiveness of employment-based reinforcement in promoting depot naltrexone adherence in opiate-dependent adults. Vivitrol, an extended-release depot formulation of naltrexone approved by the FDA for the treatment of alcohol dependence, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections once per month. Work Plus Naltrexone Prescription participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so.
Interventions
COMBINATION_PRODUCTWork Plus Naltrexone Contingency
Vivitrol, an extended-release depot formulation of naltrexone, was used. Participants were offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) were randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections once per month.
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: * met the Diagnostic and Statistical Manual (DSM)-IV criteria for opioid dependence, * reported using heroin at least 21 of the last 30 days while living in the community, * were unemployed, * were 18-65 years old, * were medically approved for naltrexone, * lived in or near Baltimore, MD. Individuals were excluded if they: * were pregnant or breastfeeding, * had serum aminotransferase levels over three times normal, * had current hallucinations, delusions, or thought disorders, current suicidal or -homicidal ideation, * expressed interest in methadone treatment, * were required to use opioids for medical purposes, * earned over $200 in taxable income over the previous 30 days, * had physical limitations that would prevent them from using a keyboard, or were incarcerated or under constant monitoring by the criminal justice system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Naltrexone Injections Received | 24 weeks | The percentage of depot naltrexone doses that participants received |
| Time to the First Missed Dose | 24 weeks | The time to the first missed dose of depot naltrexone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Percentage of 30-day Urine Samples Negative for Cocaine | Collected every 30 days for 150 days | The percentage of urine samples collected at 30-day assessments that are negative for cocaine. |
| Percentage of 30-day Urine Samples Negative for Opiates | Collected every 30 days for 150 days | Percentage of urine samples collected at the 30-day assessments that are negative for opiates |
| Percentage of M,W,F Urine Samples Negative for Opiates | Collected every Monday, Wednesday and Friday for 24 weeks | Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for opiates |
| HIV Risk Behaviors | 24 weeks | behaviors that place participants at risk for acquiring or transmitting HIV infection |
| Percentage of M-W-F Samples Negative for Cocaine | Collected every Monday, Wednesday and Friday for 24 weeks | Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for cocaine |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 Work Plus Naltrexone Prescription Work Plus Naltrexone Prescription
employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections once per month. Work Plus Naltrexone Prescription participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so. | 19 |
| 2 Work Plus Naltrexone Contingency Work Plus Naltrexone Contingency
employment-based reinforcement: Vivitrol, an extended-release depot formulation of naltrexone, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone injections once per month. Work Plus Naltrexone Prescription participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so. | 19 |
| Total | 38 |
Baseline characteristics
| Characteristic | 2 Work Plus Naltrexone Contingency | Total | 1 Work Plus Naltrexone Prescription |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 8 | 44 years STANDARD_DEVIATION 9 | 42 years STANDARD_DEVIATION 10 |
| Race/Ethnicity, Customized Black | 18 participants | 34 participants | 16 participants |
| Race/Ethnicity, Customized White | 1 participants | 4 participants | 3 participants |
| Sex: Female, Male Female | 5 Participants | 16 Participants | 11 Participants |
| Sex: Female, Male Male | 14 Participants | 22 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 19 | 4 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Naltrexone Injections Received
The percentage of depot naltrexone doses that participants received
Time frame: 24 weeks
Population: intent-to-treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Work Plus Naltrexone Prescription | Naltrexone Injections Received | 51.8 Percentage of injections received |
| Work Plus Naltrexone Contingency | Naltrexone Injections Received | 86.8 Percentage of injections received |
p-value: =0.00295% CI: [1.44, 25]General Estimating Equation (GEE)
Primary
Time to the First Missed Dose
The time to the first missed dose of depot naltrexone
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Work Plus Naltrexone Prescription | Time to the First Missed Dose | 14.74 weeks | Standard Deviation 7.67 |
| Work Plus Naltrexone Contingency | Time to the First Missed Dose | 20.84 weeks | Standard Deviation 5.59 |
p-value: 0.0081t-test, 2 sided
Secondary
Average Percentage of 30-day Urine Samples Negative for Cocaine
The percentage of urine samples collected at 30-day assessments that are negative for cocaine.
Time frame: Collected every 30 days for 150 days
Population: intent to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Work Plus Naltrexone Prescription | Average Percentage of 30-day Urine Samples Negative for Cocaine | 53.7 percentage cocaine negative urine sample |
| Work Plus Naltrexone Contingency | Average Percentage of 30-day Urine Samples Negative for Cocaine | 57.9 percentage cocaine negative urine sample |
p-value: 0.7595% CI: [0.42, 3.36]General Estimating Equation (GEE)
Secondary
HIV Risk Behaviors
behaviors that place participants at risk for acquiring or transmitting HIV infection
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Work Plus Naltrexone Prescription | HIV Risk Behaviors | 2.1 percentage of months reported | Standard Deviation 14.4 |
| Work Plus Naltrexone Contingency | HIV Risk Behaviors | 0 percentage of months reported | Standard Deviation 0 |
p-value: 0.1543t-test, 2 sided
Secondary
Percentage of 30-day Urine Samples Negative for Opiates
Percentage of urine samples collected at the 30-day assessments that are negative for opiates
Time frame: Collected every 30 days for 150 days
Population: intent to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Work Plus Naltrexone Prescription | Percentage of 30-day Urine Samples Negative for Opiates | 65.3 percentage of opiate negative |
| Work Plus Naltrexone Contingency | Percentage of 30-day Urine Samples Negative for Opiates | 71.6 percentage of opiate negative |
p-value: 0.5695% CI: [0.5, 3.6]General Estimating Equation (GEE)
Secondary
Percentage of M-W-F Samples Negative for Cocaine
Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for cocaine
Time frame: Collected every Monday, Wednesday and Friday for 24 weeks
Population: intent to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Work Plus Naltrexone Prescription | Percentage of M-W-F Samples Negative for Cocaine | 45.3 percentage of mwf cocaine negative |
| Work Plus Naltrexone Contingency | Percentage of M-W-F Samples Negative for Cocaine | 54.6 percentage of mwf cocaine negative |
p-value: =0.4195% CI: [0.6, 3.53]General Estimating Equation (GEE)
Secondary
Percentage of M,W,F Urine Samples Negative for Opiates
Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for opiates
Time frame: Collected every Monday, Wednesday and Friday for 24 weeks
Population: intent to treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Work Plus Naltrexone Prescription | Percentage of M,W,F Urine Samples Negative for Opiates | 51.8 percentage of opiate negative |
| Work Plus Naltrexone Contingency | Percentage of M,W,F Urine Samples Negative for Opiates | 66.2 percentage of opiate negative |
p-value: 0.1595% CI: [0.81, 4.1]General Estimating Equation (GEE)