Long-acting Naltrexone treatment for prisoners before release
Long-acting Naltrexone for Pre-release Prisoners: A Randomized Trial of Mobile Treatment
This study is testing if giving long-acting naltrexone shots to prisoners with opioid addiction before they are released helps them stick to treatment better and stay sober afterward.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Friends Research Institute, Inc. Academic / other |
| Locations | 1 site (Towson, Maryland) |
| Trial ID | NCT02867124 on ClinicalTrials.gov |
What this trial studies
This five-year study investigates the effectiveness of long-acting naltrexone (XR-NTX) treatment for opioid addiction in pre-release prisoners. Participants will be block randomized into two groups: one receiving XR-NTX injections in prison followed by community treatment at an opioid program, and the other receiving treatment at their place of residence. The study aims to determine if providing treatment in the community enhances adherence and overall efficacy. Conducted in five Maryland correctional facilities, the study targets inmates with a history of opioid use disorders who are preparing for release.
Who should consider this trial
Good fit: Ideal candidates are adult male or female inmates eligible for release within 30 days who have a history of opioid use disorder and are currently opioid-free.
Not a fit: Patients who are not opioid-dependent or those currently pursuing agonist treatments like methadone or buprenorphine may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could significantly improve adherence to opioid addiction treatment among recently released prisoners.
How similar studies have performed: Other studies have shown promise in using long-acting naltrexone for opioid addiction, but this specific approach of community-based treatment for pre-release prisoners is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Towson, Maryland
- Maryland Department of Public Safety and Correctional Services — Towson, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Michael S Gordon, DPA — Friends Research Institute, Inc.
- Study coordinator: Michael S Gordon, DPA
- Email: mgordon@friendsresearch.org
- Phone: 410-837-3977
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.