EXHIT ENTRE Comparative Effectiveness Trial (EXHITENTRE)

Gavin Bart

Status and phase: Completed; Phase 3; Phase 2

Conditions: Substance Use Disorder; Opioid Use Disorder, Moderate; Opioid Use Disorder, Severe

Treatments: Drug: Treatment as Usual; Drug: Extended Release Buprenorphine

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04345718

5UG1DA040316-05 (U.S. NIH Grant/Contract)

NIDA CTN 0098A

Details and patient eligibility

About

This study is a multi-site open-label randomized comparative effectiveness trial of a 28-day formulation of extended-release buprenorphine (XR-BUP) versus treatment as usual (TAU) for hospitalized patients with a moderate or severe opioid use disorder (OUD) seen by an addiction consultation service (ACS) and agreeing to initiate a medication for OUD (MOUD). Participants will be randomly assigned to XR-BUP or TAU to be received within 72 hours of anticipated hospital discharge. Follow up will occur at approximately 34, 90, and 180 days following hospital discharge.

Full description

The study will randomize approximately 314 hospitalized men and women ages 18 years and older with opioid use disorder (OUD) moderate or severe and who have not been taking prescribed medication for OUD (MOUD) for 14 days or more prior to hospitalization. Eligibility will be determined over one or more assessments during the index hospitalization. Once eligibility has been determined, participants will be randomized 1:1 to either a single injection of extended-release buprenorphine or TAU, which will include methadone, sublingual buprenorphine, or naltrexone. Connection to OUD care and ongoing MOUD following hospitalization will be per community standard. Participants will be assessed for engagement in OUD treatment by the presence of a legitimately prescribed MOUD on day 34 following hospital discharge. Further outcomes will be assessed at 90 and 180 days following hospital discharge.

Enrollment: 344 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Hospitalized.
2. At least 18 years of age.
3. Meet Diagnostic and Statistical Manual (DSM-5) criteria for moderate or severe OUD.
4. Willing to initiate MOUD, including buprenorphine.
5. Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.

Exclusion criteria

1. Anticipated length of stay less than 24-hours as determined by the ACS

2. Affected by a serious medical, psychiatric, or substance use disorder that, in the opinion of the study physician, would make it unsafe to participate in the study or may prevent collection of study data. This may include:

   1. Disabling terminal diagnosis for which discharge from hospital is not anticipated.
   2. Disabling terminal diagnosis for which hospice care is being sought.
   3. Severe alcohol or benzodiazepine use disorder that is anticipated to require complex medical detoxification which cannot be completed prior to randomization.

3. Taking a long-acting opioid other than buprenorphine (e.g., methadone, extended-release oxycodone, extended-release morphine) in the three consecutive days prior to randomization.

4. Liver enzyme tests (Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT)) more than 5 times upper limit of normal or chronic decompensated liver disease.

5. Currently pregnant.

6. Known allergy to buprenorphine or components of Atrigel delivery system.

7. Receipt of MOUD in the 14 days prior to hospitalization as maintenance treatment; however, patients may have received MOUD for withdrawal management during or prior to hospitalization at the time of enrollment.

8. Are currently in jail, prison or other overnight facility as required by court of law and/or is considered a prisoner under local law or is under current terms of civil commitment or guardianship.

9. Previously randomized as a participant in the study - individuals may only be enrolled and randomized once.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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344 participants in 2 patient groups

Interventional

Experimental group

Description:

Single subcutaneous injection of a 28-day formulation of extended-release buprenorphine within 72 hours of anticipated hospital discharge.

Treatment:

Drug: Extended Release Buprenorphine

Treatment as Usual

Active Comparator group

Description:

Community standard of care that includes initiation of either methadone, sublingual (SL) buprenorphine, or naltrexone prior to hospital discharge.

Treatment:

Drug: Treatment as Usual