EXHIT ENTRE Comparative Effectiveness Trial (NCT04345718) | Clinical Trial Compass
CompletedPhase 2/3
EXHIT ENTRE Comparative Effectiveness Trial
United States344 participantsStarted 2021-08-09
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Hospitalized.
✓. At least 18 years of age.
✓. Meet Diagnostic and Statistical Manual (DSM-5) criteria for moderate or severe OUD.
✓. Willing to initiate MOUD, including buprenorphine.
✓. Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.
Exclusion criteria
✕. Anticipated length of stay less than 24-hours as determined by the ACS
✕. 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:
✕. Disabling terminal diagnosis for which discharge from hospital is not anticipated.
✕. Disabling terminal diagnosis for which hospice care is being sought.
What they're measuring
1
The proportion of participants engaged in OUD care on the 34th day following hospital discharge.
. Severe alcohol or benzodiazepine use disorder that is anticipated to require complex medical detoxification which cannot be completed prior to randomization.
✕. 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.
✕. Liver enzyme tests (Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT)) more than 5 times upper limit of normal or chronic decompensated liver disease.