Long-acting Naltrexone for Pre-release Prisoners

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication.Following initial screening, informed consent, and medical examination, pre-release prisoners at each facility will be block randomized (N=240) within gender to either: Condition 1. XR-NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at an opioid treatment program; or Condition

2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at the patient's place of residence.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Friends Research Institute, Inc.
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Analgesics, Opioid; Naltrexone

Criteria

Inclusion Criteria:

• Adult male or female inmate at MTC, BPRU, JPRU, BCCC, or MCIW and be eligible for release within 30 days

• History of opiate disorder [meeting DSM-V criteria of dependence at the time of incarceration]

• Suitability for XR-NTX treatment as determined by medical evaluation

• Currently opioid-free by history, with negative urine for all opioids and no signs of opiate withdrawal

• Willingness to enroll in XR-NTX treatment in prison [not currently in or planning to pursue agonist (methadone, buprenorphine) treatment at release]

• Planning to live in Baltimore City or County.

• Inmates not meeting the opioid-dependence criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration

Exclusion Criteria:

• Liver function test levels greater than three times normal

• Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease). Adequately treated medical conditions are acceptable

• Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania). Adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed

• History of allergic reaction to XR-NTX

• Current chronic pain diagnosis for which opioids are prescribed

• Creatinine above normal limits

• Pregnancy (for women)

• Breast-feeding (for women)

• Suicidal ideation (within the past 6-months)

• Body Mass Index (BMI) > 40

• Unadjudicated charges that may result in transfer to another facility and/or additional prison time.