Long-acting Naltrexone for Pre-release Prisoners
Completed · Phase 3
Conditions studied: Opiate Addiction
In brief
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.
Key facts
- Study ID
- NCT02867124
- Run by
- Friends Research Institute, Inc.
- People needed
- 240
- Starts
- 2017-01-01
- Expected to finish
- 2026-01-01
- Last updated by the study team
- 2026-02-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Maryland Department of Public Safety and Correctional Services — Towson, Maryland, United States
Full record on ClinicalTrials.gov
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