An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder

This is an open-label, uncontrolled pilot study. Outpatients seeking treatment for Opiate Use
Disorder (OUD) will be screened, and those eligible who are positive for fentanyl analogues
at screening will be consented and inducted onto sublingual buprenorphine (target dose 16mg
to 24mg). On the fourth day after starting the buprenorphine induction, participants will
receive sublocade (BXR) 300mg by subcutaneious injection. Participants will be seen twice per
week for urine collection for toxicology and research assessments and will have Medication
Management counseling weekly during one of these visits. BXR will be administered monthly and
dosing will be according to the FDA prescribing instructions of 300mg for the second dose and
100mg for the third.

Inclusion Criteria:

- Individuals between the ages of 18-65

- Voluntarily seeking treatment for opioid use

- Meets current DSM-5 criteria for Opioid Use Disorder (OUD) as a primary diagnosis,
with at least moderate severity

- Test positive for Highly Potent Synthetic Opioids (HPSO) use

- Able to provide informed consent and comply with study procedures

Exclusion Criteria:

- Meets DSM-5 criteria for substance use disorder other than opioid as the primary
diagnosis

- Having a comorbid psychiatric diagnosis that might interfere with participation or
make participation hazardous, such as an active psychotic disorder or current suicide
risk

- Methadone maintenance treatment

- Buprenorphine maintenance treatment

- Known history of allergy, intolerance, or hypersensitivity to candidate medication
(buprenorphine)

- Pregnancy, lactation, or failure to use adequate contraceptive methods in female
patients, male participants are required to use adequate forms of birth control as the
exposure to Sublocade on sperm and subsequent fetal development are not known.

- Unstable medical conditions, which might make participation hazardous such as
uncontrolled hypertension (blood pressure >150/100), acute hepatitis, uncontrolled
diabetes, or elevated liver function tests (AST and ALT >3 times the upper limit of
normal

- Legally mandated to substance use disorder treatment

- Current physiological dependence on alcohol or sedative-hypnotics that would require a
medically supervised detoxification-other substance use diagnoses are not exclusionary

- Individuals, who in the clinicians judgment, have a history of failed trial of
buprenorphine or sublocade (e.g. history of severe opioid intoxication or overdoses
despite adequate adherence to buprenorphine or sublocade), or other features of the
history that strongly suggest the patient is not a good candidate for outpatient
treatment with buprenorphine.