Opioid-use Disorder Clinical Trial
Official title:
Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults
This study seeks to compare the effectiveness of two medications used to treat opioid use disorder, extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX), among adults currently incarcerated in U.S. jails and prisons at 5 distinct trial sites. This open-label, non-inferiority, head-to-head study design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of XR-B (and XR-NTX) as potentially useful re-entry and relapse prevention treatment options. It is hypothesized that XR-B is non-inferior to XR-NTX when comparing retention-in-study-medication treatment options.
Status | Recruiting |
Enrollment | 796 |
Est. completion date | December 15, 2024 |
Est. primary completion date | June 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: XR-B vs. XR-NTX Inclusions: - (1) Adult volunteer aged 18 years or older able to provide written informed consent in English (or Spanish at some sites) - (2) Current CJS incarceration (residing in a controlled environment) with pending release date (within 6 months of randomization) OR community CJS-involvement defined as: a) Current CJS incarceration (residing in a controlled environment) with pending release date (within 6 months of anticipated randomization), or; b) Community-dwelling volunteers with current CJS-involvement. [Current CJS-involvement is defined as either 1) release from any CJS incarceration or detention, or 2) under community supervision (includes parole, probation, drug or other treatment court, or other alternative to incarceration supervision) within 6 months prior to study enrollment (the date of a signed ICF)]. - (3) Current or history of moderate-to-severe opioid use disorder in the past year prior to incarceration (OUD, DSM-5) - (4) Not planning to move out of state or to new location within 6-months post-release (reasonable chance they can complete 6 months of follow-up visits). - (5) Willing to accept either XR-B or XR-NTX assignment. Non-randomized TAU Inclusions: • Recruited prior to launch of RCT or not interested in or appropriate for randomization to XR-B or XR-NTX assignment (i.e, already on methadone pre-release), but are otherwise eligible based on inclusion (#1-4, above) and exclusion (#6-10, below). Exclusion Criteria: XR-B vs. XR-NTX Exclusions: - (6) Medical or psychiatric disorders making participation unsafe or regular follow-up unlikely, (such as suicidal ideation or pre-existing moderate to severe hepatic impairment) - (7) Pregnancy, planning conception, or breast-feeding - (8) Allergy, hypersensitivity or medical contraindication to either medication - (9) Chronic pain requiring opioid pain management - (10) On daily stable methadone or buprenorphine (SL-B) maintenance every day for past 30 days prior to incarceration or monthly XR-NTX or XR-BUP 30 days or longer prior to incarceration AND intending to remain on same form of methadone or buprenorphine or XR-NTX maintenance now and upon return to the community (i.e., was in MOUD treatment pre-incarceration, on same MOUD treatment now, and plans to continue same MOUD treatment post-incarceration). (Note - If community-dwelling, already on non-study methadone, buprenorphine, or naltrexone for 30 days or longer at the time of enrollment, and planning on continuing same.) Non-randomized TAU Exclusions: • Currently treated with non-study MOUD while currently incarcerated and for 30+ days prior to incarceration, or, if community-dwelling, currently on MOUD for 30 days or longer at the time of enrollment. |
Country | Name | City | State |
---|---|---|---|
United States | Friends Research Institute | Baltimore | Maryland |
United States | Dartmouth College | Hanover | New Hampshire |
United States | Rutgers University | New Brunswick | New Jersey |
United States | Yale University School of Medicine | New Haven | Connecticut |
United States | NYU Langone Health | New York | New York |
United States | Oregon Health and Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in effectiveness of XR-B versus XR-NTX | The primary outcome measure is the number of injections during the 24-week post-release treatment phase, range 0-6. The comparison of the two arms will be based on the log-odds ratio of the injection rate for participants randomized to XR-B vs. XR-N. Retention is defined as the proportion of scheduled study medication injections received (range, 0-6). For the primary outcome, less than 6 XR-B injections will contribute to lower retention (<5 of 6), and 7+ XR-NTX will contribute only to maximum retention (6 of 6). | Weeks 1-24 | |
Secondary | Change in Opioid use | Change in opioid treatment outcomes will assess for illicit opioid use through self-reported opioid use (days per month), opioid-positive urine samples (negative vs. positive or missing, monthly), and overdose events (fatal and non-fatal), | Weeks 0, 4, 8, 12,16, 20, 24, 52 | |
Secondary | Change in Opioid treatment outcomes - adverse events | Change in Opioid use will be tracked monthly through non-fatal and fatal overdose events and other adverse events and death recorded on the Opioid Overdose AE form and the Opioid relapse outcome form. | Weeks 0, 4, 8, 12,16, 20, 24, 52 | |
Secondary | Change in Opioid treatment outcomes - lifestyle changes | Non-study addiction treatment participation, depression scores (Hamilton Depression scale) and quality of life (WHOQOL) changes will be assessed for demographic, housing, employment status changes. | Weeks 0, 4, 8, 12,16, 20, 24, 52 | |
Secondary | Change in Opioid treatment outcomes - HIV changes | Changes in HIV sex and IVDU risk scores as well as HIV and HCV status will be assessed HIV/HCV risk behaviors (RAB), HIV P24ag/ ab with reflex HIV RNA (if HIV ab negative at baseline; if HIV AB positive at baseline just check HIV RNA) and HCVAb with reflex HCV RNA if AB positive ( if AB + at baseline then just HCV VL at f/u timepoints) at baseline week 24 and week 52 | Weeks 0, 24 | |
Secondary | Change in criminal justice system (CJS) involvement with XR-B versus XR-NTX | Criminal justice system (CJS) involvement and recidivism outcomes will be measured by the number of new criminal charges, new arrests, re-incarceration episodes, and re-incarceration days by CJS public records audits. XR-B may be an effective CJS intervention alongside other OUD medications and may ultimately allow for much wider uptake of opioid agonist medication treatments in CJS populations in comparison to XR-NTX. | Weeks 4, 8, 12,16, 20, 24, 52 | |
Secondary | Change in Non-randomized Treatment-As-Usual retention compared to XR-B/XR-N. | TAU participants in this trial will be followed similarly to randomized participants but will not receive study medication or active medical treatment from the study. Prior to release from correctional controlled environment and at research visit follow-up in the community, all TAU participants will be provided education and materials that include information on opioid overdose prevention and referrals to other community addiction treatment services. TAU participants will receive the same visit incentives and study team contact, including Tracker services, as randomized participants. This amount of contact, incentives, education, and referrals are likely in excess than actual real-world 'usual care' of opioid use disorder patients released from a CJS controlled environment, and is in keeping with ethical standards for clinical trials among prisoners, in which all experimental arms must receive some tangible yet non-coercive benefit beyond usual care. | Weeks 4, 8, 12,16, 20, 24, 52 | |
Secondary | Change in Non-randomized Treatment-As-Usual rates of OUD | TAU participants, particularly those not in treatment with an OUD medication, may well face higher risk of relapse and overdose vs. active randomized participants receiving study medications. TAU participants, particularly those not in treatment with an OUD medication, may well face higher risk of relapse and overdose vs. active randomized participants receiving study medications. | Weeks 4, 8, 12,16, 20, 24, 52 |
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