RECRUITING

OUD (Opioid Use Disorder) Target Trial

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

In this research study the investigators will work with 80-participants with opioid use disorder who are starting treatment with the medication buprenorphine and are trying to quit using opioids. The investigators are trying to learn two things: 1. Can an MRI brain marker be used to predict which participants will be successful in quitting opioids with buprenorphine? 2. Does adjunctive treatment with repetitive Transcranial Magnetic Stimulation (rTMS) help people quit using opioids more than a sham (placebo) version of rTMS? In order to complete the study the investigators will ask participants to: * Complete an MRI within 5-days of starting buprenorphine and again after they are on a full stable dose 1-3 weeks later. * Undergo study-treatment with 30-sessions of either real or placebo rTMS in as little as 1-week (10-sessions-per-day for five days) or as long as over 6-weeks. * Meet with the investigators once per week over the following 12-weeks to see if the participants have been able to quit using opioids over that time.

Official Title

The Development and Validation of Neural Targets in Opioid Use Disorder

Quick Facts

Study Start:2024-12-31
Study Completion:2026-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06585709

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. Age 18 or older; all genders included.
  2. 2. Intellectual level sufficient to provide informed consent and accurately complete assessment instruments (English speaking/writing).
  3. 3. Meet DSM-5 criteria for moderate or severe OUD. Individuals may also meet criteria for another substance use disorder (with the exception of alcohol or sedative/hypnotic); but must identify opioids as their primary substance.
  4. 4. Starting buprenorphine and planning on opioid abstinence
  1. 1. Pregnant, breast-feeding, or planning on getting pregnant.
  2. 2. Alcohol or sedative/hypnotic use disorders (seizure risk).
  3. 3. History of/or current psychotic disorder (e.g. schizophrenia).
  4. 4. Current or lifetime bipolar disorder.
  5. 5. Unstable Axis-I condition requiring starting a new medication.
  6. 6. Active suicidal ideation / suicide attempt within 90 days.
  7. 7. History of/or current dementia or other cognitive impairment.
  8. 8. Contraindications to receiving rTMS or undergoing MRI (implanted ferromagnetic metal, history of or high risk of seizure, implanted device).
  9. 9. Unstable general medical conditions.

Contacts and Locations

Study Contact

Gregory Sahlem
CONTACT
(984) 340-0761
quitopioids@duke.edu

Principal Investigator

Gregory Sahlem
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Duke University

  • Gregory Sahlem, PRINCIPAL_INVESTIGATOR, Duke University

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 Date2024-12-31
Study Completion Date2026-10-31

Study Record Updates

Study Start Date2024-12-31
Study Completion Date2026-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder