Long-acting Naltrexone for Pre-release Prisoners

Launched by FRIENDS RESEARCH INSTITUTE, INC. · Aug 10, 2016

Keywords

ClinConnect Summary

This clinical trial is studying how well a medication called long-acting Naltrexone (XR-NTX) can help people who are about to be released from prison and have struggled with opioid addiction. The goal is to see if giving patients their injections of XR-NTX at home, rather than at a treatment center, will help them stick to their treatment plan better and improve their recovery. The study will involve 240 adult participants who are currently in several correctional facilities and will be randomly assigned to either receive their injections at a treatment facility or at their home after they are released.

To be eligible for this trial, participants must be adults who are set to be released from prison within 30 days and have a history of opioid dependence. They should be opioid-free at the time of screening and willing to participate in the treatment program. Participants can expect to receive one injection while still in prison, followed by six monthly injections after their release. It’s important to know that certain health conditions, such as severe liver issues or untreated mental health problems, will prevent someone from joining the study, as the safety of participants is a top priority.

Gender

ALL

Eligibility 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.