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| Name | Class |
|---|---|
| Alkermes, Inc. | INDUSTRY |
| New York City Department of Health and Mental Hygiene | OTHER_GOV |
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This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.
This protocol randomizes persons soon-to-be-released from a large urban jail to treatment with extended-release naltrexone (XR-NTX), a full opioid antagonist that prevents the activity of heroin and other opioids. Investigators at NYUSOM and NYC DOHMH will recruit heroin dependent persons from NYC jails who are soon-to-be-released, not accessing opioid agonist pharmacotherapy, with lowered tolerance due to incarceration, and extremely likely to relapse and risk accidental overdose at release. All N=40 participants receive a two-session, individual psychosocial intervention, Motivational Interviewing. Half (n=20) will be randomized to pre-release treatment with XR-NTX. Immediately and one month following release, participants will be offered continued psychosocial and medication-assisted treatment (naltrexone, buprenorphine, or methadone) at Bellevue Hospital, including a second XR-NTX dose among XR-NTX arm participants. The primary outcome is relapse to sustained opioid use during the first 30 days post-release. We hypothesize an XR-NTX arm will report significantly lower rates of sustained opioid relapse following release.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended-release naltrexone (XR-NTX) | Active Comparator | A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection. |
|
| Motivational Enhancement Counseling Only | Placebo Comparator | The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended-Release Naltrexone | Drug | 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-Release Opioid Relapse | Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days. | Four weeks post-release |
| Measure | Description | Time Frame |
|---|---|---|
| Participation in Community Drug Treatment Post-release | This secondary outcome tracks community drug treatment initiation four weeks post-release from jail. Measured by self-report community drug treatment initiation at week 4 study visit. | Four weeks post-release |
| Any Opioid Use Post-release |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua D Lee, MD MSc | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States | ||
| New York City Department of Correction |
| 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. | |
| 25703440 | Derived | Lee JD, McDonald R, Grossman E, McNeely J, Laska E, Rotrosen J, Gourevitch MN. Opioid treatment at release from jail using extended-release naltrexone: a pilot proof-of-concept randomized effectiveness trial. Addiction. 2015 Jun;110(6):1008-14. doi: 10.1111/add.12894. Epub 2015 Apr 5. |
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Of the 48 consented participants enrolled into study between January 2010-May 2013, 34 were randomized into one of two trial arms, with n=17 to Extended-Release Naltrexone arm and n=17 to the Motivational Enhancement Counseling Only arm (treatment-as-usual).
Recruitment of participants took place at NYC jail medical clinics (Rikers Island; EMTC, RMSC) with follow-up visits taking place at Bellevue Hospital. The last participant completed in June 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended-release Naltrexone (XR-NTX) | A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection. Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly). |
| FG001 | Motivational Enhancement Counseling Only | The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Baseline analysis determined based on: (1) successful randomization into one of two treatment arms (ETAU;XR-NTX) and (2) actual release from jail back to the community. One participant who successfully randomized to XR-NTX was never released from jail custody and was instead sent to prison and therefore excluded from final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Extended-release Naltrexone (XR-NTX) | A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection. Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Post-Release Opioid Relapse | Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days. | One XR-NTX participant randomized was excluded from final data analysis due to the fact he was never released from jail to community, so primary outcome (post-release opioid relapse) could not be measured. | Posted | Number | 95% Confidence Interval | participants | Four weeks post-release |
|
Adverse Events collected during 8 weeks post-release.
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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 | Extended-release Naltrexone (XR-NTX) | A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection. Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anticipated XR-NTX Symptoms | General disorders | Non-systematic Assessment | Anticipated XR-NTX Symptoms including nausea, upset stomach, injection site soreness, dizziness, headache, and other flu-like symptoms. |
Limitations of this pilot study are: small sample size, no females enrolled in study, and no placebo control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua D. Lee | NYU School of Medicine | 212-263-4242 | joshua.lee@nyumc.org |
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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 |
|---|---|
| C000624616 | vivitrol |
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| Motivational Enhancement Counseling | Behavioral | The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. |
|
Counts of any opioid use, defined as self-reported ≥ 1 day of heroin or other opioid use as measured by the Timeline Follow-Back assessment during the first 4 weeks post-release. |
| Four weeks post-release |
| Injection Drug Use Post-release | This secondary outcome tracks any injection drug use and frequency of injection drug use in the four weeks following release from jail. | Four weeks post-release |
| Accidental Drug Overdose | Accidental drug overdose is defined as patient self-report of any event consistent with over-sedation or respiratory suppression following ingestion of alcohol, prescription, or illicit drugs. | Four weeks post-release |
| Adverse Events and Serious Adverse Events | AEs and SAEs per standard definitions will be measured by self-report. | Eight weeks post-release |
| New York |
| New York |
| 11370 |
| United States |
| BG001 | Motivational Enhancement Counseling Only | The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Motivational Enhancement Counseling Only | The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. |
|
|
| Secondary | Participation in Community Drug Treatment Post-release | This secondary outcome tracks community drug treatment initiation four weeks post-release from jail. Measured by self-report community drug treatment initiation at week 4 study visit. | One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community. | Posted | Number | percentage of participants | Four weeks post-release |
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|
|
| Secondary | Any Opioid Use Post-release | Counts of any opioid use, defined as self-reported ≥ 1 day of heroin or other opioid use as measured by the Timeline Follow-Back assessment during the first 4 weeks post-release. | One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community. | Posted | Number | percentage of participants | Four weeks post-release |
|
|
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| Secondary | Injection Drug Use Post-release | This secondary outcome tracks any injection drug use and frequency of injection drug use in the four weeks following release from jail. | Posted | Number | percentage of participants by arm | Four weeks post-release |
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| Secondary | Accidental Drug Overdose | Accidental drug overdose is defined as patient self-report of any event consistent with over-sedation or respiratory suppression following ingestion of alcohol, prescription, or illicit drugs. | One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community. | Posted | Number | participants | Four weeks post-release |
|
|
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| Secondary | Adverse Events and Serious Adverse Events | AEs and SAEs per standard definitions will be measured by self-report. | One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community. | Posted | Number | participants | Eight weeks post-release |
|
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| 0 |
| 16 |
| 5 |
| 16 |
| EG001 | Motivational Enhancement Counseling Only | The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. | 0 | 17 | 1 | 17 |
|
| Shoulder Seperation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Respiratory Problems | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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