Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail (NCT04408313) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail
United States240 participantsStarted 2020-10-28
Plain-language summary
The proposed study is a Type 1 hybrid effectiveness-implementation trial. Individuals with opioid use disorder in county jails throughout the state of Maryland will be randomly assigned within gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a community treatment program. Arm 2. XR-NTX (n=120). One injection of XR-NTX in jail, followed by 6 monthly injections post-release at a community treatment program.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Adult male or female inmates at participating jails who are eligible for release within 120 days
* History of opioid use disorder (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration)
* Suitability for XR-B and/or XR-NTX treatment as determined by medical evaluation
* Willingness to enroll in XR-B or XR-NTX treatment in jail
* Planning to live in one of the 7 participating counties and/or surrounding counties
Exclusion Criteria:
* Liver function test levels greater than 4 times normal;
* Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; moderate to severe renal impairment; adequately treated medical conditions are acceptable);
* Conditions or medications that may predispose to QTc prolongation (personal or family history of long QT syndrome, hypokalemia, medications that prolong QTc interval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrythmics, antipsychotics and antidepressant)
* 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 naltrexone and/or buprenorphine;
* Cu…