Opioid Use Disorder
Conditions
Keywords
Buprenorphine, Substance use disorder 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.
Interventions
DRUGBuprenorphine
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.
Sponsors
Yale University
National Drug Abuse Treatment Clinical Trials Network
The Emmes Company, LLC
National Institute on Drug Abuse (NIDA)
Alameda Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
This study is a multi-site double-blind, double-dummy randomized clinical trial. Only the DSC staff overseeing the random assignment schedule, a few designated CCC staff, and the central research staff preparing the study medication will be unblinded; all other study personnel and participants will remain blinded to treatment arm until the nationwide completion of the trial and the database is formally locked. Detailed information on the study procedures regarding the double-blinding will be contained in a standalone Blinding Management Plan and Study Site Blinding Plan. A DSMB will review study data throughout the course of the trial in a blinded fashion (e.g., masked treatment assignments), however they can request to be unblinded at any time.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engagement in Treatment (10) | Within 10 days after study randomization | The proportion of patients in each of the two study arms participating in OUD treatment within 10 days after the study randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Craving | Measured daily for 10 days post randomization | 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). |
| Withdrawal | Measured daily for 10 days post randomization | 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). |
| Substance Use | Measured daily for 10 days post randomization | 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 |
| Engagement in Treatment (30) | Within 30 days after randomization | The proportion of patients in each of the two study arms participating in OUD treatment |
Countries
United States
Contacts
CONTACTGail D'Onofrio, MD, MS
CONTACTKathryn Hawk, MD, MHS
PRINCIPAL_INVESTIGATORGail D'Onofrio, MD, MS
Yale University
PRINCIPAL_INVESTIGATORKathryn Hawk
Yale University
Outcome results
None listed