Overview

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