Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DA019497 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
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 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Intervention | No Intervention | Participants were offered depot naltrexone injections and were not required to take scheduled injections to work. | |
| Employment-based reinforcement | Experimental | Participants were offered depot naltrexone injections and were required to take scheduled injections to work. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| employment-based reinforcement | Combination Product | Participants in the "Work Plus Naltrexone Contingency" condition were required to take scheduled doses of depot naltrexone to work and earn wages. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Depot Naltrexone Doses Received | The number of depot naltrexone injections received/divided by the total number of injections possible for each participant. | 18 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Time to the First Missed Dose of Depot Naltrexone | The number of weeks until the first missed dose of depot naltrexone | 18 weeks |
| Percentage of 30-day Assessments Urine Samples Negative for Opiates |
Not provided
Individuals were eligible if they:
Individuals were excluded if they
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenneth Silverman, Ph.D. | Johns Hopkins University | 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 |
|---|---|---|---|
| 21320227 | Result | Everly JJ, DeFulio A, Koffarnus MN, Leoutsakos JM, Donlin WD, Aklin WM, Umbricht A, Fingerhood M, Bigelow GE, Silverman K. Employment-based reinforcement of adherence to depot naltrexone in unemployed opioid-dependent adults: a randomized controlled trial. Addiction. 2011 Jul;106(7):1309-18. doi: 10.1111/j.1360-0443.2011.03400.x. Epub 2011 May 3. | |
| 21782353 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Volunteers were recruited from detoxification programs in Baltimore, MD and through street outreach between October, 2006 and April, 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Work Plus Naltrexone Prescription | Participants who completed the oral naltrexone induction 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. |
| FG001 | Work Plus Naltrexone Contingency | Participants who completed the oral naltrexone induction 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 will earn access to working and earning salary by taking depot naltrexone injections for 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Percentage of Depot Naltrexone Doses Received | The number of depot naltrexone injections received/divided by the total number of injections possible for each participant. | Posted | Mean | Full Range | percentage of injections | 18 Weeks |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 completed 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Liver Function Test | Hepatobiliary disorders | Systematic Assessment | The liver function test results were greater than 3 times the normal limits of liver transaminases. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenneth Silverman | Hopkins School of Medicine: Department of Psychiatry | 410-550-2694 | ksilverm@jhmi.edu |
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019970 | Cocaine-Related Disorders |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
(The number of urine samples that were negative for opiates/total number of urine samples)x 100
| 4 months |
| 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 | 18 weeks |
| 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 | 4 months |
| 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 | 18 weeks |
| HIV Risk Behaviors | Went to a crack house | 4 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Work Plus Naltrexone Contingency | Participants will be offered an inpatient opioid detoxification and an oral naltrexone induction. Participants who completed 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. "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. |
|
|
|
| Secondary | The Time to the First Missed Dose of Depot Naltrexone | The number of weeks until the first missed dose of depot naltrexone | Posted | Mean | Standard Deviation | weeks | 18 weeks |
|
|
|
|
| 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 | Posted | Mean | Full Range | percentage of opiate negative | 4 months |
|
|
|
| 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 | Posted | Mean | Full Range | percentage of opiate negative | 18 weeks |
|
|
|
| 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 | Posted | Mean | Full Range | percentage of cocaine negative | 4 months |
|
|
|
|
| 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 | intent to treat | Posted | Mean | Full Range | percentage of cocaine negative | 18 weeks |
|
|
|
| Secondary | HIV Risk Behaviors | Went to a crack house | Posted | Mean | Standard Deviation | percentage of months reported | 4 months |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 4 |
| 17 |
| EG001 | 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 completed 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. " | 0 | 18 | 0 | 18 | 9 | 18 |
|
| Headache | Vascular disorders | Systematic Assessment |
|
| Injection site reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Reduced sex drive | Reproductive system and breast disorders | Systematic Assessment |
|
| Sleeplessness | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D001519 | Behavior |