Using rTMS to Explore Neural Mechanisms of Stress-Induced Opioid Use

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will use a stress (vs. placebo) exposure model, paired with single-session sham vs. active rTMS at two distinct cortical locations (dlPFC vs. mPFC in parallel groups) to assess whether rTMS neuromodulation at these alternative loci differentially influence stress-reactivity and opioid reinforcement in non-treatment seeking participants with OUD. Stress-reactivity will be measured using cognitive, affective, behavioral and biological phenotypes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wayne State University
• Treatments: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Yohimbine

Criteria

Inclusion Criteria:

• Meet DSM-5 criteria for OUD

• Age 21-60 yr

• Right handed

• Males and non-pregnant/non-lactating females

• Cognitively intact (total IQ score >80 on Shipley Institute of Living Scale

• Screening cardiovascular indices within ranges for safe use of the pharmacological stressor: resting HR 50-90 bpm, systolic BP 90-140 mmHg, and diastolic BP 50-90 mmHg

• Use alcohol and/or marijuana <3 times/week; each "time" should consist of <1 marijuana "joint" equivalent and <3 alcoholic drinks.

Exclusion Criteria:

• Under influence of any substance during session

• Past 7-day use of illicit drugs other than opioids (except marijuana, which is legal in Michigan)

• Urinalysis positive for cocaine metabolites, benzodiazepines, barbiturates, amphetamines or pregnancy

• Medical conditions prohibiting use of rTMS (e.g. seizure history; based on rTMS screening questionnaire)

• Lifetime diagnosis of: psychotic disorder, bipolar disorder, generalized anxiety disorder, or obsessive compulsive disorder; major depression in the past 5 years; or potentially antisocial personality disorder (if the clinical psychologist judges such behaviors to be potentially disruptive or unsafe in our lab)

• Past-year SUD other than OUD

• Acute/unstable illness: conditions making it unsafe for participation (e.g. neurological, cardiovascular, pulmonary, or systemic diseases)

• Lactose intolerance (placebo dose)

• Any prohibited medications: medications that lower seizure threshold, psychiatric medications, prescription pain medications, or blood pressure medications

• Chronic head or neck pain

• Past-month participation in a research study