Opioid Use Disorder
Conditions
Brief 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 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.
Interventions
Active rTMS will be delivered with a MagVenture MagPro X100 rTMS device with a Cool-B65-AP coil. rTMS will be applied to a personalized treatment target within the Left-Dorsolateral Prefrontal Cortex using a Localite Neuronavigation device.
Sham rTMS in an identical fashion to the active-rTMS condition will be delivered via the built-in e-sham system in the MagVenture device.
DIAGNOSTIC_TESTHigh Ventral Striatal Reactivity
We will test for ventral striatal reactivity using a Reassessment of Craving MRI task and define high ventral striatal reactivity as having \>mean voxels in the ventral striatum activate
DIAGNOSTIC_TESTLow Ventral Striatal Reactivity
We will test for ventral striatal reactivity using a Reassessment of Craving MRI task and define low ventral striatal reactivity as having \<mean voxels in the ventral striatum activate
Sponsors
Stanford University
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older; all genders included. 2. Intellectual level sufficient to provide informed consent and accurately complete assessment instruments (English speaking/writing). 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. Starting buprenorphine and planning on opioid abstinence
Exclusion criteria
1. Pregnant, breast-feeding, or planning on getting pregnant. 2. Alcohol or sedative/hypnotic use disorders (seizure risk). 3. History of/or current psychotic disorder (e.g. schizophrenia). 4. Current or lifetime bipolar disorder. 5. Unstable Axis-I condition requiring starting a new medication. 6. Active suicidal ideation / suicide attempt within 90 days. 7. History of/or current dementia or other cognitive impairment. 8. Contraindications to receiving rTMS or undergoing MRI (implanted ferromagnetic metal, history of or high risk of seizure, implanted device). 9. Unstable general medical conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Relapse Free survival | Up to 12 weeks | The number of participants who have not met relapse criteria in the 12-week follow-up phase. Relapse is defined as a) any opioid use in 4 consecutive weeks, or b) any opioid use on 7 consecutive days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weeks of opioid abstinance | 12-weeks | Number of weeks in the 12-week follow-up period that the participant is abstinent from opioids based on self-report and a negative urine drug test |
Countries
United States
Contacts
Primary ContactGregory Sahlem
Outcome results
None listed