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Table 1 CSP#2014: VA-BRAVE eligibility criteria

From: Rationale, design and methods of VA-BRAVE: a randomized comparative effectiveness trial of two formulations of buprenorphine for treatment of opioid use disorder in veterans

Inclusion criteria

Exclusion criteria

Use of opioids within 30 days prior to consent or within 30 days prior to entry into a supervised setting

Meets DSM-5 criteria for moderate to severe OUD

Referred to/seeking treatment for OUD

New episode of care, defined as requiring induction on buprenorphine OR taking a form of prescribed medication treatment for OUD continuously for < 30 days prior to consent

Veterans < 18 years of age

Females unwilling to practice an effective method of birth control for the duration of the study

History of significant adverse effects from buprenorphine and/or naloxone

Recent suicidal or homicidal ideation or psychosis that requires hospitalization

Unable or unwilling to provide consent

Meets criteria for current DSM-5 sedative hypnotic use disorder

Pending felony charges

Conditions which, in the judgement of the Local Site Investigator, make it unlikely the patient can participate in or complete the 52-week active phase of the study, including current moderate-to-severe COVID-19 symptoms with a risk of intubation or critical illness

Is actively participating in another interventional clinical trial for which a waiver of dual-enrollment with VA-BRAVE has not been obtained