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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
360
All patients will receive 3 pills and will be observed for 2 hours post-study medication administration with repeated COWS at approximately hours 1 and 2. All participants will be given a referral for ongoing MOUD and will be discharged with a prescription for 16 mg daily of buprenorphine daily.
Highland Hospital
Oakland, California, United States
RECRUITINGSan Leandro Hospital
San Leandro, California, United States
RECRUITINGMaine Medical Center
Portland, Maine, United States
Engagement in Treatment (10)
The proportion of patients in each of the two study arms participating in OUD treatment within 10 days after the study randomization
Time frame: Within 10 days after study randomization
Craving
The maximum intensity of opioid cravings during the preceding 24 hours assessed daily for 10 days post randomization using a numerical rating scale (0 to 10).
Time frame: Measured daily for 10 days post randomization
Withdrawal
The maximum intensity of opioid withdrawal symptoms during the preceding 24 hours assessed daily for 10 days post randomization using a numerical rating scale (0 to 10).
Time frame: Measured daily for 10 days post randomization
Substance Use
The number of days with illicit opioid and other substance use based on self-reported data obtained daily during the first 10 days post randomization
Time frame: Measured daily for 10 days post randomization
Engagement in Treatment (30)
The proportion of patients in each of the two study arms participating in OUD treatment
Time frame: Within 30 days after randomization
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Cooper University Hospital
Camden, New Jersey, United States
RECRUITINGUniversity of Utah Hospital
Salt Lake City, Utah, United States
RECRUITING