RECRUITING

Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This pilot trial will explore the feasibility, acceptability, and effectiveness of the most recently approved formulation of injectable extended-release buprenorphine (XR-BUP) for treatment of opioid use disorder (OUD) in rural settings. We will randomize 144 eligible individuals with moderate to severe OUD in a 2:1 ratio to one of two medication conditions: (1) XR-BUP (128mg target), administered every 4 weeks or (2) SL-BUP (16mg-24 mg/day target).Participants will receive study medication treatment for the 14 week-intervention period, including an initial \~2-week period of induction/stabilization. The study will use a mixed-methods approach (participant assessments, study medication records, qualitative interviews) for assessing feasibility and acceptability, and results will include patient outcome data on the comparative effectiveness of XR-BUP versus SL-BUP for patients with OUD in rural settings.

Official Title

Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings

Quick Facts

Study Start:2024-10-14
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06023459

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be ≥18 years of age
  2. 2. Meet DSM-5 criteria for moderate to severe OUD or be on buprenorphine medication for OUD
  3. 3. Be interested in receiving buprenorphine treatment for OUD
  4. 4. Be willing to be randomized to either SL-BUP or XR-BUP
  5. 5. Be willing to comply with all study procedures
  6. 6. Be in good general health, as determined by the study Medical Clinician based on medical/psychiatric histories and physical exam, to permit treatment in an outpatient setting
  7. 7. If female of childbearing potential, be willing to practice an effective method of birth control for the duration of participation in the study intervention and agree to study-administered pregnancy testing during their participation in the study
  8. 8. Be able to speak English sufficiently to understand the study procedures
  9. 9. Be willing and able to provide written informed consent to participate in the study
  1. 1. Have evidence of a serious psychiatric disorder as assessed by the study Medical Clinician that would make participation difficult or unsafe (e.g., active psychosis, severe depression, or mania)
  2. 2. Have suicidal or homicidal ideation or behavior that requires immediate attention
  3. 3. Have a medical condition or serious medical illness that, in the opinion of the study Medical Clinician, would make study participation medically unsafe
  4. 4. Have been in treatment with naltrexone within 28 days of consent
  5. 5. Have been in methadone maintenance treatment within 28 days of consent
  6. 6. Be taking medication or require any medication that, in the judgment of the study Medical Clinician, could interact adversely with study medication
  7. 7. Have known allergy or sensitivity to SL-BUP or XR-BUP formulations or their components
  8. 8. Be currently incarcerated or have pending legal action that could preclude participation in study activities
  9. 9. Have other situation that might prevent the participant from remaining in the area for the duration of the study (e.g., planned move)
  10. 10. Have a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use, as determined by the study Medical Clinician, that would require a different level of care and preclude safe participation in the study
  11. 11. Be currently pregnant or breastfeeding or planning on conception

Contacts and Locations

Study Contact

Megan Black, MPH
CONTACT
310-985-3696
MBlack@mednet.ucla.edu
Cynthia Boubion, BA
CONTACT
CBoubion@mednet.ucla.edu

Principal Investigator

Yih-Ing Hser, PhD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Larissa Mooney, MD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

AppleGate Recovery El Dorado
El Dorado, Arkansas, 71730
United States
Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital
Garberville, California, 95542
United States
Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness
Gibson City, Illinois, 60936
United States
Penobscot Community Health Care Inc. - Seaport Community Health Center
Belfast, Maine, 04915
United States
Oregon Health & Science University Primary Care Clinic, Scappoose
Scappoose, Oregon, 97056
United States
Providence Northeast Washington Medical Group
Colville, Washington, 99114
United States
New Beginnings Recovery Clinic & Behavioral Health Center
New Martinsville, West Virginia, 26155
United States

Collaborators and Investigators

Sponsor: Yih-Ing Hser

  • Yih-Ing Hser, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles
  • Larissa Mooney, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-14
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2024-10-14
Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

  • Opioid Use Disorder
  • Opioid Medication Assisted Treatment
  • Buprenorphine
  • Comparative Effectiveness Research

Additional Relevant MeSH Terms

  • Opioid-Related Disorders
  • Substance-Related Disorders
  • Narcotic-Related Disorders