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Active rTMS for Opioid Use Disorder

N/A
Waitlist Available
Led By Gregory Sahlem
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Age 18 or older; all genders included.
2. Intellectual level sufficient to provide informed consent and accurately complete assessment instruments (English speaking/writing).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights

Summary

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 50-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.

Eligible Conditions
  • Opioid Use Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with Relapse Free survival
Secondary study objectives
Number of participants with high ventral striatal reactivity using the Reassessment of Craving (ROC) task
Number of participants with low ventral striatal reactivity using the Reassessment of Craving (ROC) task

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active rTMSExperimental Treatment1 Intervention
A total of 50-sessions of standard iTBS (1800 pulses) will be delivered. rTMS-sessions will be ideally administered over 1-week (10-sessions-per-day, 50-minutes inter-session-interval, 5-days), but there will be flexibility in the delivery paradigm so long as participants complete all sessions of rTMS within 6 weeks and come in at least twice per week.
Group II: Sham rTMSPlacebo Group1 Intervention
Double-blind sham-rTMS in an identical fashion to the active-rTMS condition will be delivered.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active repetitive Transcranial Magnetic Stimulation (rTMS)
2015
N/A
~30

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,424 Previous Clinical Trials
3,066,555 Total Patients Enrolled
Stanford UniversityOTHER
2,447 Previous Clinical Trials
17,482,639 Total Patients Enrolled
Gregory SahlemPrincipal InvestigatorDuke University
2 Previous Clinical Trials
25 Total Patients Enrolled
~53 spots leftby Jul 2026