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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01DA019497-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Drug Abuse (NIDA) | NIH |
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In this 5-year study, the investigators propose to evaluate the separate and combined effects of the FDA-approved formulation of extended release naltrexone (Vivitrol®) and employment-based reinforcement of opiate abstinence in promoting opiate abstinence and reducing risky injection behavior in recently detoxified, opioid-dependent, injection drug users.
Injection heroin use is a chronic problem that fuels the transmission of HIV/AIDS through risky injection behaviors. Methadone and buprenorphine can reduce heroin use and risky injection behavior; however, they have abuse potential, produce physical dependence, can produce lethal overdose, are highly regulated, and some patients simply do not want agonist treatment. Opiate detoxifications can serve as an alternative to agonist treatment, but many injection drug users relapse to heroin use and resume risky injection behaviors after detoxification. Vivitrol®, an extended release formulation of naltrexone, was recently approved by the FDA for the treatment of opioid dependence, but its clinical utility is uncertain given the reluctance of many opioid-dependent adults to maintain its long-term use, and the fact that some patients continue to use opiates while under naltrexone blockade. The investigators research in the first period of this grant showed that employment-based reinforcement can be highly effective in promoting long-term adherence to Vivitrol®. Employment-based reinforcement may be ideally suited to address the limitations of extended release naltrexone by capitalizing on its potential to simultaneously reinforce naltrexone adherence and opiate abstinence. This grant will evaluate the effectiveness of employment-based reinforcement to simultaneously promote high rates of Vivitrol® adherence and increase opiate abstinence. After an opioid detoxification and induction onto oral naltrexone, participants will be invited to attend the Therapeutic Workplace for 24 weeks (where they can work and earn wages) and will be randomly assigned to one of four groups that will differ in whether they receive Vivitrol®, employment-based opiate abstinence reinforcement, both or neither. Participants in Vivitrol® conditions will be required to take scheduled injections to work and earn wages. Participants exposed to opiate abstinence reinforcement will receive a temporary decrease in their workplace pay if they fail to provide an opiate-free urine sample. The study will assess the effects of the interventions on weekly opiate urinalysis results, and on measures of injection drug use and cocaine use. If this study shows that the combined use of Vivitrol® and employment-based reinforcement of adherence and opiate abstinence is effective in maintaining long-term opiate abstinence, this model of employment-based addiction pharmacotherapy could be integrated into community workplaces to disseminate the effective use of Vivitrol®; it could be used to enhance the utility of other new antagonist-like addiction medications; and it could provide an effective means of reducing injection drug use in individuals who persist in injecting heroin and exposing themselves and others to the risk of acquiring or transmitting HIV infection due to their continued injection drug use and risky injection behaviors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivitrol Only | Experimental | The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes. |
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| VIVITROL&Opiate Abstinence Reinforcement | Experimental | This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour. |
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| Opiate Abstinence Reinforcement Only | Experimental | This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivitrol | Drug | Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Weekly Urine Samples Negative for Opiates | Was the participant's urine sample negative for opiates at each of the 24 weekly assessments scheduled after random assignment (Y/N)? The outcome measure was the percentage of weekly urine samples that was negative for opiates. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Weekly Urine Samples Negative for Cocaine | Was the participant's urine sample negative for cocaine at each of the 24 weekly assessments scheduled after random assignment (Y/N)? The outcome measure was the percentage of weekly urine samples that was negative for cocaine. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Silverman, Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Center for Learning and Health | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40342086 | Derived | Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3. |
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We will publish the results in a peer-reviewed journal.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vivitrol Only | The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes. Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Usual Care Control | Other | This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling. |
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| Employment-based opiate abstinence reinforcement | Behavioral | This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour. |
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| Usual Care Control | Other | Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling. |
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| FG001 | VIVITROL&Opiate Abstinence Reinforcement | This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour. |
| FG002 | Opiate Abstinence Reinforcement Only | This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL. Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour. |
| FG003 | Usual Care Control | This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling. Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vivitrol Only | The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes. Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks. |
| BG001 | VIVITROL&Opiate Abstinence Reinforcement | This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour. |
| BG002 | Opiate Abstinence Reinforcement Only | This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL. Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour. |
| BG003 | Usual Care Control | This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling. Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percent of Weekly Urine Samples Negative for Opiates | Was the participant's urine sample negative for opiates at each of the 24 weekly assessments scheduled after random assignment (Y/N)? The outcome measure was the percentage of weekly urine samples that was negative for opiates. | Posted | Mean | Full Range | percentage of negative urine samples | 24 weeks |
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| Secondary | Percent of Weekly Urine Samples Negative for Cocaine | Was the participant's urine sample negative for cocaine at each of the 24 weekly assessments scheduled after random assignment (Y/N)? The outcome measure was the percentage of weekly urine samples that was negative for cocaine. | Posted | Mean | Full Range | percentage of cocaine negative samples | 24 weeks |
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1 year
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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 | Vivitrol Only | The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes. Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks. | 0 | 25 | 2 | 25 | 6 | 25 |
| EG001 | VIVITROL&Opiate Abstinence Reinforcement | This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour. | 0 | 23 | 1 | 23 | 3 | 23 |
| EG002 | Opiate Abstinence Reinforcement Only | This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL. Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour. | 1 | 18 | 2 | 18 | 3 | 18 |
| EG003 | Usual Care Control | This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling. Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling. | 0 | 18 | 4 | 18 | 9 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Nervous system disorders | Systematic Assessment | The participant never received extended-release naltrexone and all of her urine samples were negative for opiates. At her 6-month follow-up assessment, we were and was told that she had died. The medical examiner believes she had a seizure. |
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| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Chest pain | Cardiac disorders | Non-systematic Assessment |
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| Diabetes | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Viral menningitis | Nervous system disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Seizure | Nervous system disorders | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
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| alcohol detoxification | Psychiatric disorders | Non-systematic Assessment |
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| Psychiatric treatment | Psychiatric disorders | Non-systematic Assessment |
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| Stroke | Nervous system disorders | Non-systematic Assessment |
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| Weakness on right side of body | Nervous system disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Abnormal liver function test | Hepatobiliary disorders | Non-systematic Assessment |
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| elbow injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Assault | General disorders | Non-systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Broken ribs | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| hallucinations | Psychiatric disorders | Non-systematic Assessment |
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| infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Injection site reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Back injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| leg injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| arm injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Psychiatric treatment | Psychiatric disorders | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Liver discomfort | Hepatobiliary disorders | Non-systematic Assessment |
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| Sinus infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
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Small sample size
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Silverman | Johns Hopkins University School of Medicine | 410-550-2694 | ksilverm@jhmi.edu |
| 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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| ID | Term |
|---|---|
| C000624616 | vivitrol |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Odds Ratio (OR) |
| 0.58 |
| 2-Sided |
| 95 |
| 0.1 |
| 4.6 |
| Superiority |
| General Estimating Equation (GEE) | 0.11 | Odds Ratio (OR) | 6.00 | 2-Sided | 95 | 0.7 | 54.9 | Superiority |
| General Estimating Equation (GEE) | 0.39 | Odds Ratio (OR) | 2.66 | 2-Sided | 95 | 0.3 | 24.9 | Superiority |
| General Estimating Equation (GEE) | 0.03 | Odds Ratio (OR) | 10.4 | 2-Sided | 95 | 1.3 | 85.5 | Superiority |
| OG002 | Opiate Abstinence Reinforcement Only | This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL. Employment-based opiate abstinence reinforcement: This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour. |
| OG003 | Usual Care Control | This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling. Usual Care Control: Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling. |
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