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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA019497-02 | U.S. NIH Grant/Contract | View source | |
| NA_00000928 | Other Identifier | Johns Hopkins Medicine IRB |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Work Plus Naltrexone Prescription | No Intervention | Participants could work and earn vouchers but did not to take Vivitrol Injections to work and earn vouchers. | |
| Work Plus Naltrexone Contingency | Experimental | Participants could work and earn vouchers and had to take Vivitrol Injections to work and earn vouchers: employment-based reinforcement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Work Plus Naltrexone Contingency | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Naltrexone Injections Received | The percentage of depot naltrexone doses that participants received | 24 weeks |
| Time to the First Missed Dose | The time to the first missed dose of depot naltrexone | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of 30-day Urine Samples Negative for Opiates | Percentage of urine samples collected at the 30-day assessments that are negative for opiates | Collected every 30 days for 150 days |
| Percentage of M-W-F Samples Negative for Cocaine |
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Individuals were eligible if they:
Individuals were excluded if they:
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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 |
|---|---|---|---|---|---|---|
| The Center for Learning and Health | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21782353 | Result | DeFulio A, Everly JJ, Leoutsakos JM, Umbricht A, Fingerhood M, Bigelow GE, Silverman K. Employment-based reinforcement of adherence to an FDA approved extended release formulation of naltrexone in opioid-dependent adults: a randomized controlled trial. Drug Alcohol Depend. 2012 Jan 1;120(1-3):48-54. doi: 10.1016/j.drugalcdep.2011.06.023. Epub 2011 Jul 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Work Plus Naltrexone Prescription | Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Prescription" condition could work and earn salary independent of whether or not they took depot naltrexone injections. |
| FG001 | Work Plus Naltrexone Contingency | Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were prescribed depot naltrexone for 6 months. "Work Plus Naltrexone Contingency" participants were required to take monthly depot naltrexone injections to work and earn salary. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Naltrexone Injections Received | The percentage of depot naltrexone doses that participants received | intent-to-treat | Posted | Mean | Full Range | Percentage of injections received | 24 weeks |
|
Every month for 6 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 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenneth Silverman | Johns Hopkins School of Medicine: Department of Psychiatry" | 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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Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for cocaine
| Collected every Monday, Wednesday and Friday for 24 weeks |
| 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. | Collected every 30 days for 150 days |
| HIV Risk Behaviors | behaviors that place participants at risk for acquiring or transmitting HIV infection | 24 weeks |
| 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 | Collected every Monday, Wednesday and Friday for 24 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
Participants who completed the oral naltrexone induction (N=38) were randomly assigned to one of two groups. Both groups were invited to work in the Therapeutic Workplace and were 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.
|
|
|
| Primary | Time to the First Missed Dose | The time to the first missed dose of depot naltrexone | Posted | Mean | Standard Deviation | weeks | 24 weeks |
|
|
|
|
| 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 | intent to treat | Posted | Mean | Full Range | percentage of opiate negative | Collected every 30 days for 150 days |
|
|
|
|
| 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 | intent to treat | Posted | Mean | Full Range | percentage of mwf cocaine negative | Collected every Monday, Wednesday and Friday for 24 weeks |
|
|
|
|
| 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. | intent to treat | Posted | Mean | Full Range | percentage cocaine negative urine sample | Collected every 30 days for 150 days |
|
|
|
|
| Secondary | HIV Risk Behaviors | behaviors that place participants at risk for acquiring or transmitting HIV infection | Posted | Mean | Standard Deviation | percentage of months reported | 24 weeks |
|
|
|
|
| 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 | intent to treatment | Posted | Mean | Full Range | percentage of opiate negative | Collected every Monday, Wednesday and Friday for 24 weeks |
|
|
|
|
| 0 |
| 19 |
| 2 |
| 19 |
| EG001 | 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. | 0 | 19 | 4 | 19 |
| Reduced sex drive | Reproductive system and breast disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Sleeplessness | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
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