Opiate Dependence
Conditions
Keywords
opiate dependence, naltrexone, reinforcement, behavior therapy, cocaine dependence, risk reduction behavior
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 over 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting naltrexone adherence in opiate-dependent adults. An extended-release depot formulation of naltrexone will be used. Participants will be offered an inpatient opioid detoxification and naltrexone induction. Participants who complete the oral naltrexone induction 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. Patients in the Work Plus Naltrexone Contingency condition will earn access to working and earning salary by taking depot naltrexone 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_PRODUCTemployment-based reinforcement
Participants in the Work Plus Naltrexone Contingency condition were required to take scheduled doses of depot naltrexone to work and earn wages.
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 of Mental Disorders, 4th. Edition (DSM-IV) criteria for opioid dependence, * reported using heroin on at least 21 of the last 30 days while in community, * were unemployed, * were aged 18-65 years, * were medically approved for naltrexone * lived in or near Baltimore, MD. Individuals were excluded if they * had current DSM-IV major Axis I disorders, * had current suicidal or homicidal ideation, * expressed interest in methadone treatment, * were required to use opioids for medical purposes, * earned more than $200 in taxable income over the previous 30 days, * had physical limitations that would prevent them from using a keyboard, * were pregnant or breastfeeding, * had serum aminotransferase levels more than three times over normal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Depot Naltrexone Doses Received | 18 Weeks | The number of depot naltrexone injections received/divided by the total number of injections possible for each participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of 30-day Assessments Urine Samples Negative for Opiates | 4 months | (The number of urine samples that were negative for opiates/total number of urine samples)x 100 |
| Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates | 18 weeks | Total number of opiate-negative urine samples divided by the total number of possible urine samples X 100 |
| The Time to the First Missed Dose of Depot Naltrexone | 18 weeks | The number of weeks until the first missed dose of depot naltrexone |
| Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine | 18 weeks | Total number of cocaine-negative urine samples divided by the total number of possible urine samples X 100 |
| HIV Risk Behaviors | 4 months | Went to a crack house |
| Percentage of 30-day Assessments Urine Samples Negative for Cocaine | 4 months | (The number of urine samples that were negative for cocaine/total number of urine samples)x 100 |
Countries
United States
Participant flow
Recruitment details
Volunteers were recruited from detoxification programs in Baltimore, MD and through street outreach between October, 2006 and April, 2008.
Pre-assignment details
Participants were required to complete opioid detoxification and were invited to attend the therapeutic workplace for induction onto oral naltrexone. During induction, participants were required to take scheduled oral naltrexone doses to gain access to the therapeutic workplace. Induction continued until three consecutive doses were ingested.
Participants by arm
| Arm | Count |
|---|---|
| Work Plus Naltrexone Prescription An extended-release depot formulation of naltrexone was used. Participants were offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who complete the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Work Plus Naltrexone Prescription participants were encouraged to take depot naltrexone for 6 months, but access to working and earning salary will not be contingent on doing so. | 17 |
| Work Plus Naltrexone Contingency An extended-release depot formulation of naltrexone was used. Participants were offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who complete the oral naltrexone induction (N=35) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone. Participants in the Work Plus Naltrexone Contingency condition earned access to working and earning salary by taking depot naltrexone injections for 6 months. | 18 |
| Total | 35 |
Baseline characteristics
| Characteristic | Work Plus Naltrexone Prescription | Work Plus Naltrexone Contingency | Total |
|---|---|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 6 | 43 years STANDARD_DEVIATION 7 | 42 years STANDARD_DEVIATION 6 |
| Region of Enrollment United States | 17 participants | 18 participants | 35 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 4 / 17 | 9 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 |
Outcome results
Primary
Percentage of Depot Naltrexone Doses Received
The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.
Time frame: 18 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Work Plus Naltrexone Prescription | Percentage of Depot Naltrexone Doses Received | 42.2 percentage of injections |
| Work Plus Naltrexone Contingency | Percentage of Depot Naltrexone Doses Received | 80.6 percentage of injections |
p-value: =0.00895% CI: [1.61, 20.02]General Estimating Equation (GEE)
Secondary
HIV Risk Behaviors
Went to a crack house
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Work Plus Naltrexone Prescription | HIV Risk Behaviors | 5 percentage of months reported | Standard Deviation 22 |
| Work Plus Naltrexone Contingency | HIV Risk Behaviors | 5 percentage of months reported | Standard Deviation 23 |
p-value: 0.95995% CI: [0.071, 16.245]General Estimating Equation (GEE)
Secondary
Percentage of 30-day Assessments Urine Samples Negative for Cocaine
(The number of urine samples that were negative for cocaine/total number of urine samples)x 100
Time frame: 4 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Work Plus Naltrexone Prescription | Percentage of 30-day Assessments Urine Samples Negative for Cocaine | 54.4 percentage of cocaine negative |
| Work Plus Naltrexone Contingency | Percentage of 30-day Assessments Urine Samples Negative for Cocaine | 55.6 percentage of cocaine negative |
p-value: 0.93995% CI: [0.32, 3.42]General Estimating Equation (GEE)
Secondary
Percentage of 30-day Assessments Urine Samples Negative for Opiates
(The number of urine samples that were negative for opiates/total number of urine samples)x 100
Time frame: 4 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Work Plus Naltrexone Prescription | Percentage of 30-day Assessments Urine Samples Negative for Opiates | 61.8 percentage of opiate negative |
| Work Plus Naltrexone Contingency | Percentage of 30-day Assessments Urine Samples Negative for Opiates | 73.6 percentage of opiate negative |
Secondary
Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine
Total number of cocaine-negative urine samples divided by the total number of possible urine samples X 100
Time frame: 18 weeks
Population: intent to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Work Plus Naltrexone Prescription | Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine | 48.9 percentage of cocaine negative |
| Work Plus Naltrexone Contingency | Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine | 55.6 percentage of cocaine negative |
Secondary
Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates
Total number of opiate-negative urine samples divided by the total number of possible urine samples X 100
Time frame: 18 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Work Plus Naltrexone Prescription | Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates | 51.6 percentage of opiate negative |
| Work Plus Naltrexone Contingency | Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates | 72.0 percentage of opiate negative |
Secondary
The Time to the First Missed Dose of Depot Naltrexone
The number of weeks until the first missed dose of depot naltrexone
Time frame: 18 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Work Plus Naltrexone Prescription | The Time to the First Missed Dose of Depot Naltrexone | 9.3 weeks | Standard Deviation 6.8 |
| Work Plus Naltrexone Contingency | The Time to the First Missed Dose of Depot Naltrexone | 15.5 weeks | Standard Deviation 4.5 |
p-value: 0.0033t-test, 2 sided