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| ID | Type | Description | Link |
|---|---|---|---|
| 69665 | Other Grant/Funding Number | Laura and John Arnold Foundation |
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| Name | Class |
|---|---|
| Laura and John Arnold Foundation | OTHER |
| Alkermes, Inc. | INDUSTRY |
| FHR (Fellowship Health Resources, Inc.) | OTHER |
| Wake County Recovery Court |
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In preparation for a large-scale randomized controlled trial (RCT) of Vivitrol® effectiveness in drug courts, investigators propose a feasibility study in the Wake County, North Carolina drug court, where an estimated 50% of clients are opioid dependent.
Aim 1: Pilot RCT. Pilot-test the delivery of Vivitrol® treatment for 10-20 interested and eligible clients of the Wake County Drug Court.
Aim 1. Pilot RCT. The pilot delivery of Vivitrol® in the Wake County Drug Court will be carried out with 20-40 eligible drug court clients under treatment by Fellowship Health Resources, Inc. (FHR), the community behavioral health treatment agency that is the contracted treatment provider for the Wake County Drug Court. Participants will be randomized in equal number to receive Vivitrol® plus treatment as usual (TAU) or TAU only. TAU for drug court clients receiving services at FHR includes psychosocial treatment such as individual or group therapy, and sometimes also oral naltrexone for clients who are medically eligible and interested in taking the medication, the cost of which is covered by the agency for uninsured clients. (FHR currently administers Vivitrol® for a small number of interested agency clients with health insurance that covers the medication; the vast majority of their drug court clients are uninsured and so have no real access to the extended-release formulation due to its high cost.) Vivitrol® is an FDA-approved extended-release injectable form of naltrexone. Naltrexone is also available in oral, but not extended release, form. Naltrexone is an opioid antagonist that "blocks" opioid receptors in the brain to stop pleasurable feelings associated with taking opioids. Potentially eligible subjects will be drug court-referred FHR clients willing and eligible to take Vivitrol®, and willing to be randomly assigned to Vivitrol® or TAU. Potential subjects already under treatment with oral naltrexone at FHR would be eligible to enter the study if willing to switch to injectable Vivitrol® if randomly assigned. Study subjects who are randomized to Vivitrol® would receive a once-monthly injection of Vivitrol® for 12 months, or less if they decide to stop receiving Vivitrol® or to drop out of the study. Those randomized to TAU would continue with treatment as before, which could including (1) staying on oral naltrexone if already on it, (2) considering starting oral naltrexone, if interested, or (3) continuing with psychosocial treatment only. The Vivitrol® will be administered by study medical personnel at FHR. Randomization to the Vivitrol® arm would add urine pregnancy testing to FHR's existing Vivitrol® medical evaluation protocol and consent process, which currently screens for pregnancy without requiring a urine test. A urine pregnancy test will be administered once per month for female study participants of child-bearing age who are in the Vivitrol® group. All drug court clients, including study participants in both study groups, have urine drug tests at least once per week as part of program participation.
In addition to participating in Vivitrol® and psychosocial treatment, pilot RCT participants will provide consent for FHR and the drug court to share information with the study team about their demographic and clinical characteristics, treatment participation (e.g., outpatient group therapy), and court-related events (e.g., type of conviction that led to their drug court participation, missed drug court appointments, sanctions for program violations, and the results of drug screens).
Participants will also provide two face-to-face interviews at baseline and 6 months after baseline, about their interest and experience in Vivitrol® and/or other medication-assisted treatment (MAT), other treatment preferences, level of functioning, quality of life, and engagement in employment or education.
Outcome measures include treatment participation, compliance with drug court conditions, arrests and incarcerations, treatment satisfaction, and self-reported subjective measures of functioning and quality of life.
If a participant chooses not to participate in the study at any time, it will not affect his/her relationship with the court, FHR, right to health care, or participation in the study interview data collection. Site staff will follow participants for the purposes of collecting research and safety information. Investigators discontinue Vivitrol® or oral naltrexone in circumstances such as: adverse reactions to the medication; a change in medical status that makes it unsafe for a participant to continue receiving the medication, including pregnancy; or a participant becoming ill during the study. Participants who discontinue Vivitrol® or oral naltrexone for any reason may continue to participate in interviews for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivitrol | Active Comparator | All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is naltrexone for extended-release injectable suspension. It is an injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). |
|
| Oral naltrexone | Active Comparator | Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone for extended-release injectable suspension | Drug | Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12 months if they continue to be medically eligible and willing. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With New Arrests | Any new arrests during the 12-month study period. This information will be collected from administrative records. | 12 months |
| Number of Participants With New Incarcerations | Any new incarceration during the 12-month study period. This information will be collected from administrative records. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Positive Drug Screens | Number of times a client had a positive drug screen. This information will be collected from administrative records. | 12 months |
| Number of Sanctions Imposed by the Court |
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Inclusion Criteria:
Exclusion Criteria*:
Is pregnant (i.e., has a positive pregnancy test), planning to become pregnant, or breastfeeding during the study
Has a positive urine drug test for opioids, buprenorphine or methadone at the beginning of treatment and before each Vivitrol® injection
Has used any opioid drug within 10 days prior to treatment
Has a condition, disease state, previous medical history, or observed abnormalities (including physical examination, laboratory evaluation [e.g., kidney or liver function test result], or urinalysis finding) at screening that, in the opinion of the investigator, would preclude safe participation in the study or affect the ability of the subject to adhere to the protocol visit schedule, fulfill visit requirements, or would interfere with the study assessments, including, but not limited to, the following:
Has had a DSM-5 diagnosis within the past 12 months of other psychiatric conditions or disorders that, in the investigator's opinion, could interfere with participation in the study
Is currently physiologically dependent on any psychoactive substance (except caffeine, or tobacco) requiring medical intervention for detoxification
Has a history of hypersensitivity or adverse reaction to naltrexone, or naloxone
Has had significant suicidal ideation or behavior within the past year, as assessed with the Patient Health Questionnaire (PHQ-9)
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| Name | Affiliation | Role |
|---|---|---|
| Allison G Robertson, PhD, MPH | Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fellowship Health Resources (FHR) | Raleigh | North Carolina | 27612 | United States |
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| Label | URL |
|---|---|
| Vivitrol prescribing information | View source |
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Fourteen subjects consented to be in the study and completed a baseline interview. Four were terminated from court thereby losing eligibility, so they were not randomized.
Community treatment provider Fellowship Health Resources (FHR) prescreened 19 people as eligible. Two declined to participate and 3 were terminated from court and lost eligibility, leaving 14 potential subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vivitrol | All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12 |
| FG001 | Oral Naltrexone | Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vivitrol | All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12 |
| 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 | Number of Participants With New Arrests | Any new arrests during the 12-month study period. This information will be collected from administrative records. | Due to the nature of this pilot phase study, all statistical analyses are considered exploratory. | Posted | Count of Participants | Participants | 12 months |
|
Approximately 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 | Vivitrol | All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug overdose (unrelated) | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incarceration >5 days | Social circumstances | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michele Easter, Ph.D. | Duke University | 919-385-0862 | michele.easter@duke.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2016 | Jun 10, 2020 | Prot_001.pdf |
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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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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| C000624616 | vivitrol |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| FED |
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|
| Oral naltrexone | Drug | Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing. |
|
|
Number of sanctions imposed by the court (e.g., brief stays in jail). This information will be collected from administrative records.
| 12 months |
| Number of Missed Court Appointments | Number of missed court appointments during the 12-month study period. This information will be collected from administrative records. | 12 months |
| Vivitrol Participation | Number of Vivitrol injections from either arm of study. This information will be collected from administrative records. | 12 months |
| Treatment Participation (Non-Vivitrol) | Number of oral naltrexone monthly prescriptions from either arm of study. This information will be collected from administrative records. | 12 months |
| Change in Subjective Functioning: Medical Status | Subjective assessment of medical status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months. | Baseline, 6 months |
| Number of Participants Who Reported Improvement in Subjective Functioning: Employment/Support Status | Subjective assessment of employment opportunities collected via interviews at baseline and approximately six months. | Baseline, 6 months |
| Number of Participants Who Reported Improvement in Substance Use | Subjective assessment of alcohol/drug use in past 30 days collected via interviews at baseline and approximately six months. | Baseline, 6 months |
| Number of Participants Who Reported Illegal Behavior | Subjective assessment of illegal behavior using the question, "Have you done anything that was against the law in the last 30 days?" collected via interviews approximately six months after baseline. | approximately 6 months |
| Number of Participants Who Reported Improvement in Subjective Functioning: Family/Social Relationships | Subjective assessment of family and social relationships using a single question about satisfaction with relationships over the past 30 days collected via interviews at baseline and approximately six months. | Baseline, approximately 6 months |
| Change in Subjective Functioning: Psychiatric Status | Subjective assessment of psychiatric status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months. | Baseline, approximately 6 months |
| Treatment Satisfaction Score | Reported as average of 12-item treatment satisfaction score at approximately six months. A score of 5 indicates strong agreement with positive statements about treatment satisfaction; a score of 0 indicates strong disagreement. | Approximately 6 months |
| Change in Medication-assisted Treatment (MAT) Attitudes | Change in MAT attitudes from baseline to follow-up. The average score of 4 questions about MAT for substance use disorder were calculated at baseline and follow-up, and the average score at baseline was subtracted from the average score at follow-up. The averages are based on questions for which a score of 5 indicates strong agreement with statements about MAT; a score of 1 indicates strong disagreement with such statements. | Baseline, approximately 6 months |
| BG001 | Oral Naltrexone | Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Oral Naltrexone | Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing. |
|
|
| Primary | Number of Participants With New Incarcerations | Any new incarceration during the 12-month study period. This information will be collected from administrative records. | Due to the nature of this pilot phase study, all statistical analyses are considered exploratory. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Positive Drug Screens | Number of times a client had a positive drug screen. This information will be collected from administrative records. | Due to the nature of this pilot phase study, all statistical analyses are considered exploratory. | Posted | Mean | Standard Deviation | positive drug screens | 12 months |
|
|
|
| Secondary | Number of Sanctions Imposed by the Court | Number of sanctions imposed by the court (e.g., brief stays in jail). This information will be collected from administrative records. | Due to the nature of this pilot phase study, all statistical analyses are considered exploratory. | Posted | Mean | Standard Deviation | sanctions | 12 months |
|
|
|
| Secondary | Number of Missed Court Appointments | Number of missed court appointments during the 12-month study period. This information will be collected from administrative records. | Due to the nature of this pilot phase study, all statistical analyses are considered exploratory. | Posted | Mean | Standard Deviation | missed court appointments | 12 months |
|
|
|
| Secondary | Vivitrol Participation | Number of Vivitrol injections from either arm of study. This information will be collected from administrative records. | Some subjects in the oral naltrexone arm received Vivitrol through other means. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory. | Posted | Mean | Standard Deviation | Vivitrol injections | 12 months |
|
|
|
| Secondary | Treatment Participation (Non-Vivitrol) | Number of oral naltrexone monthly prescriptions from either arm of study. This information will be collected from administrative records. | Due to the nature of this pilot phase study, all statistical analyses are considered exploratory. | Posted | Mean | Standard Deviation | oral naltrexone monthly prescriptions | 12 months |
|
|
|
| Secondary | Change in Subjective Functioning: Medical Status | Subjective assessment of medical status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months. | Data not collected. | Posted | Baseline, 6 months |
|
|
| Secondary | Number of Participants Who Reported Improvement in Subjective Functioning: Employment/Support Status | Subjective assessment of employment opportunities collected via interviews at baseline and approximately six months. | Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory. | Posted | Count of Participants | Participants | Baseline, 6 months |
|
|
|
| Secondary | Number of Participants Who Reported Improvement in Substance Use | Subjective assessment of alcohol/drug use in past 30 days collected via interviews at baseline and approximately six months. | Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory. | Posted | Count of Participants | Participants | Baseline, 6 months |
|
|
|
| Secondary | Number of Participants Who Reported Illegal Behavior | Subjective assessment of illegal behavior using the question, "Have you done anything that was against the law in the last 30 days?" collected via interviews approximately six months after baseline. | Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory. | Posted | Count of Participants | Participants | approximately 6 months |
|
|
|
| Secondary | Number of Participants Who Reported Improvement in Subjective Functioning: Family/Social Relationships | Subjective assessment of family and social relationships using a single question about satisfaction with relationships over the past 30 days collected via interviews at baseline and approximately six months. | Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory. | Posted | Count of Participants | Participants | Baseline, approximately 6 months |
|
|
|
| Secondary | Change in Subjective Functioning: Psychiatric Status | Subjective assessment of psychiatric status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months. | Data not collected. | Posted | Baseline, approximately 6 months |
|
|
| Secondary | Treatment Satisfaction Score | Reported as average of 12-item treatment satisfaction score at approximately six months. A score of 5 indicates strong agreement with positive statements about treatment satisfaction; a score of 0 indicates strong disagreement. | Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory. | Posted | Mean | Standard Deviation | score on a scale | Approximately 6 months |
|
|
|
| Secondary | Change in Medication-assisted Treatment (MAT) Attitudes | Change in MAT attitudes from baseline to follow-up. The average score of 4 questions about MAT for substance use disorder were calculated at baseline and follow-up, and the average score at baseline was subtracted from the average score at follow-up. The averages are based on questions for which a score of 5 indicates strong agreement with statements about MAT; a score of 1 indicates strong disagreement with such statements. | Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory. | Posted | Mean | Standard Deviation | score on a scale | Baseline, approximately 6 months |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
| EG001 | Oral Naltrexone | Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing. | 0 | 5 | 1 | 5 | 2 | 5 |
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| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |