RECRUITING

A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use

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

The goal of this clinical trial is to compare buprenorphine formulations (sublingual buprenorphine versus long-acting injectable buprenorphine) for treating opioid use disorder among individuals who use fentanyl and/or other high potency synthetic opioids. Individuals aged 18-65 will be eligible for enrollment. The main questions it aims to answer are: Are there differences in frequency of drug use after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine? Are there differences in rates of sustained relapse after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine? Investigators also seek to understand and explore: How factors like body fat, body weight, and quantity of fentanyl use before treatment influence treatment outcomes. How blood levels of buprenorphine and its metabolite norbuprenorphine early on in treatment may influence treatment outcomes. How factors like craving and opioid withdrawal symptoms influence treatment outcomes. Participants will: Complete a brief overnight hospital stay in an inpatient research unit. This hospital stay will enable participants to start treatment with either sublingual buprenorphine or injectable buprenorphine. Provide blood and urine samples while on the inpatient unit and at follow up. Complete in-person follow up visits at 1-, 2-, 3- and 4-weeks after leaving the hospital to measure drug use, craving, withdrawal, quality of life, and physical health.

Official Title

A Randomized Controlled Trial Examining Extended-Release Injectable Buprenorphine in Those Who Use High Potency Synthetic Opioids

Quick Facts

Study Start:2025-09
Study Completion:2029-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06726200

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 to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18 to 65
  2. * Voluntarily seeking treatment for opioid use disorder (OUD)
  3. * Consistent use of fentanyl or other high potency synthetic opioids
  4. * Meets DSM-5 criteria for OUD with at least moderate severity
  5. * Able to provide written informed consent in English and willing to comply with study procedures
  1. * Meets DSM-5 criteria for another substance use disorder as the primary diagnosis
  2. * Has an active, unmanaged psychiatric condition that would make participation hazardous (e.g., acute, psychosis, current suicidality, current manic episode)
  3. * Has an active, unmanaged medical condition that would make participation hazardous or preclude use of buprenorphine or ancillary medications for withdrawal (e.g., unmanaged hypertension, unmanaged diabetes, clinically significant abnormality on ECG, acute hepatitis)
  4. * Buprenorphine or methadone treatment in the past 30 days
  5. * Known allergy, hypersensitivity or intolerance to buprenorphine
  6. * Pregnancy, lactation, or unwillingness to use adequate contraceptive methods
  7. * Current physiological dependence on sedative-hypnotics or alcohol that would require medically supervised detoxification
  8. * Liver function tests \> 2x the upper limit of normal
  9. * Use of medications or herbal products with known CYP3A4 inhibition or induction properties in the past 30 days

Contacts and Locations

Study Contact

Rachel Luba, PhD
CONTACT
646-774-8189
RRL2117@CUMC.Columbia.edu
John Mariani, MD
CONTACT
212-923-3031
Jmm2330@cumc.columbia.edu

Study Locations (Sites)

Substance Treatment and Research Service
New York, New York, 10019
United States

Collaborators and Investigators

Sponsor: Rachel R. Luba

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 Date2025-09
Study Completion Date2029-01-15

Study Record Updates

Study Start Date2025-09
Study Completion Date2029-01-15

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder