Health TrialsbyHealthPanel

Buprenorphine for Individuals in Jail

ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFriends Research Institute, Inc.

About this trial

This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult male or female inmates at participating jail who are eligible for release within 120 days (sentenced and/or pretrial [note: individuals who might be sentenced to state/federal prison will be excluded]); Those individuals who are pre-trial and/or sentenced who are completing their sentence in the community (probation, parole, home detention, electronic monitoring, drug or other treatment court [or equivalent]) will be eligible to participate;

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 SL-B treatment as determined by medical evaluation;

Willingness to enroll in XR-B or SL-B treatment in jail and continue in the community;

Disqualifiers

Liver function test levels greater than 5 times normal (if we are unable to obtain labs, a determination by the study physician will be made to allow inclusion);

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • extended-release buprenorphine (XR-B)

    Drug

    buprenorphine

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: extended-release buprenorphine (XR-B)Experimental treatment 1 intervention
Group B: sublingual buprenorphine (SL-B)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

urine toxicology

positive urine drug screen for opioids

Time frame
12-months
2

days of opioid use

Number of days since last assessment

Time frame
12-months
3

time to opioid relapse

days from release from jail to first relapse event

Time frame
12-months

Secondary outcomes

1

retention in buprenorphine treatment

days receiving buprenorphine

Time frame
6-months
2

urine toxicology for other illicit substance use

positive urine drug screen

Time frame
12-months
3

days of illicit substance use

number of days since last assessment

Time frame
12-months
4

overdose events

fatal and non-fatal overdose events

Time frame
12-months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Friends Research Institute, Inc.

Lead sponsor

Source ClinicalTrials.gov
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