RECRUITING

Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose

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 investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg). The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), improved treatment response based on use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (exploratory outcome).

Official Title

Randomized Clinical Trial of a 16 Mg Vs. 24 Mg Maintenance Daily Dose of Buprenorphine to Increase Retention in Treatment Among People with Opioid Use Disorder

Quick Facts

Study Start:2025-01-06
Study Completion:2028-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06316830

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. * English-speaking
  2. * Age 18 years-old or older
  3. * Identified by the treating physician as having moderate to severe opioid use disorder (OUD)
  4. * Initiating or continuing buprenorphine for treatment of opioid use disorder
  5. * History of fentanyl use (confirmed by fentanyl positive urine drug screen (UDS) at intake OR if on buprenorphine maintenance treatment fentanyl plus a positive UDS within the last month OR self- reported ongoing fentanyl use during treatment)
  1. * Previous enrollment in the trial
  2. * Incarcerated or in police custody\*
  3. * Pregnant
  4. * Live outside of Rhode Island (RI)
  5. * Unable to provide informed consent
  6. * Allergy to Buprenorphine
  7. * Concomitant medication use deemed to present potential for serious medication interaction by the treating clinician \*Participants that become incarcerated/or in police custody during the study will be withdrawn.

Contacts and Locations

Study Contact

Alyssa Peachey, MHA
CONTACT
401-808-6950
alyssa_peachey@brown.edu
Rachel Wightman, MD
CONTACT
rachel_wightman@brown.edu

Study Locations (Sites)

Brown University
Providence, Rhode Island, 02912
United States

Collaborators and Investigators

Sponsor: Rhode Island Hospital

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 Date2025-01-06
Study Completion Date2028-04-30

Study Record Updates

Study Start Date2025-01-06
Study Completion Date2028-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder