Clinical trial NCT06494904: Standard Versus High Dose ED-Initiated Buprenorphine Induction
Official title: ED-Initiated Standard Versus High Dose Buprenorphine Induction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Opioid Use Disorder
Keywords: Buprenorphine
Substance use disorder treatment
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Drug Abuse Treatment Clinical Trials Network
name: The Emmes Company, LLC
name: National Institute on Drug Abuse (NIDA)
name: Alameda Health System
First posted: 2024-07-10
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multisite double-blind, double-dummy, randomized clinical trial enrolling ED patients with untreated moderate to severe opioid use disorder (OUD) to compare Standard Dose Induction (SDI) and High Dose Induction (HDI) on rates of participation in OUD treatment within 10 days post randomization, and opioid withdrawal symptoms, opioid craving, and use of illicit and non-prescribed drugs.

Detailed description: This study will recruit, train, and provide resources to approximately 4 ED systems throughout the U.S. to recruit ED patients presenting with OUD not receiving medications for opioid use disorder (MOUD) as part of an RCT to compare SDI (Zubsolv 5.7/1.4 mg buprenorphine/naloxone\* plus 2 placebo tablets) with HDI (three Zubsolv 5.7/1.4 mg\* buprenorphine/naloxone tablets) to evaluate rate of participation in OUD treatment within 10 days post-randomization and differences in outcomes of tolerability, opioid withdrawal symptoms, craving, and use of illicit drugs.

Eligibility criteria: Inclusion Criteria:

All patients enrolled into the study must:

1. Be 18-65 years of age.
2. Be treated in the ED during study screening hours.
3. Meet DSM-5 diagnostic criteria for moderate to severe OUD.
4. Have a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment).
5. Have a urine toxicology test that is positive for opioids.
6. Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

All patients enrolled into the study must not:

1. Have a medical or psychiatric condition that requires hospitalization at the time of index ED visit.
2. Have a known hypersensitivity reaction to buprenorphine/naloxone
3. Be actively suicidal or severely cognitively impaired precluding informed consent.
4. Require ongoing prescription for opioid analgesics.
5. Have a physical exam or reported history consistent with severe liver failure
6. Have a positive urine test for methadone and reported use in the past 72 hours
7. Be a prisoner or in police custody at the time of index ED visit.
8. Be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments)
9. Have prior enrollment in the current study.
10. Receiving MOUD treatment within the past 7 days.
11. Be pregnant as determined by human gonadotropin (hCG) testing at the index ED visit
12. Have a respiratory rate \<8 or oxygen saturation \<93%
13. Be a participant in any other clinical trial in which medications are being delivered or the use of an investigational drug or device within the last 30 days

Primary outcomes:
measure: Engagement in Treatment (10)
timeFrame: Within 10 days after study randomization
Secondary outcomes:
measure: Craving
timeFrame: Measured daily for 10 days post randomization
measure: Withdrawal
timeFrame: Measured daily for 10 days post randomization
measure: Substance Use
timeFrame: Measured daily for 10 days post randomization
measure: Engagement in Treatment (30)
timeFrame: Within 30 days after randomization
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Highland Hospital
state: California
city: San Leandro
country: United States
facility: San Leandro Hospital
state: California
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
affiliation: Yale University
name: Gail D'Onofrio, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Kathryn Hawk
role: PRINCIPAL_INVESTIGATOR
References: