Helping people with opioid use disorders avoid relapses after leaving jail / George E. Woody [and three others].

Format:

Book

Author/Creator:

Woody, George E., author.

Series:

Final research report (Patient-Centered Outcomes Research Institute (U.S.))

Final research report

Language:

English

Subjects (All):

Outcome assessment (Medical care).

Physical Description:

1 online resource.

Place of Publication:

Washington, DC : Patient-Centered Outcomes Research Institute (PCORI), 2021.

Summary:

BACKGROUND: Correctional facilities have a high prevalence of persons with moderate to severe opioid use disorders (OUDs). Usual treatment is detoxification using clonidine and nonopioid medications for insomnia, achiness, and other withdrawal-related symptoms with referral to community treatment after release, but failure to keep appointments and relapse are common. Injectable extended-release naltrexone (XR-NTX), an antagonist that blocks opioid receptors for about 4 weeks after a single dose and is approved for preventing relapse, might be helpful, particularly if given before release. OBJECTIVES: Determine whether providing XR-NTX to incarcerated people with OUDs before release (BR) results in less relapse during the first 3 months after release (AR) than when XR-NTX is offered by referral to a local provider AR. METHODS: Consenting, detoxified incarcerated people with OUDs who were interested in XR-NTX and met study enrollment criteria were randomly assigned 1:1 to receive XR-NTX BR or AR with 3 monthly follow-up doses, weekly counseling, and assessments through month 6. Continuing monthly XR-NTX dosing was available from Northeast Treatment Centers (NET) Steps, a methadone program, via Medicaid. PRIMARY OUTCOME: Proportion of participants who relapsed during the first 3 months as determined by ≥10 days of reported opioid use, withdrawal after stopping use, and/or ≥2 more opioid positive urine tests within a 4-week period, as determined by clinic visits or a supplemental follow-up questionnaire. RESULTS: Recruitment was slower than planned, with 402 incarcerated people with OUDs expressing interest in the study, 222 consenting to participate, and 146 meeting enrollment criteria and being randomly assigned. Uncertainty about release dates resulted in a time lag between randomization and final disposition during which 60 of the randomly assigned participants were sentenced to other facilities, withdrew consent, or became otherwise unavailable for study treatment. Due to high rates of missing urine drug screens and follow-up data on the remaining 86 participants (n = 38 BR, n = 48 AR), we developed a brief but untested phone-based questionnaire about opiate use and withdrawal to signal the presence/absence of relapse. Using it to supplement other data we were able to confirm relapse or nonrelapse for 63 of the 86 participants (73%). BR participants received more XR-NTX than AR participants due to higher rates of receipt of the initial dose; however, nonrelapse by month 3 was not significantly different for the BR (39.5%) vs AR (25%) groups (χ22 = 3.23, P = .20). Dropout was high in both groups such that 21 of the 86 participants (24%) remained on XR-NTX at month 3 (12 BR, 9 AR), and 19 participants remained on XR-NTX at month 4 (9 BR, 10 AR). CONCLUSIONS: Incarcerated people with OUDs who were interested in XR-NTX were more likely to receive the first dose if it was offered BR rather than AR, but there was no significant difference in relapse between groups by month 3. However, the lower-than-planned number of participants and high proportion of missing data make this finding inconclusive. Developing methods to improve adherence AR is an important and major challenge for incarcerated people who express interest in XR-NTX treatment. LIMITATIONS: The study limitations included smaller-than-planned sample size; unexpected loss of randomly assigned participants before initiation of treatment; high rates of dropout and large amounts of missing data after initiation of treatment; and reliance on self-reports from an untested phone-based interview for the primary outcome.

Notes:

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