rTMS of Limbic Circuitry in Stress Modulation in Healthy Volunteers

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will be conducted with healthy male and female participants. Aim 1 will determine during sham repetitive transcranial magnetic stimulation (rTMS) how a drug stressor combination (yohimbine + hydrocortisone) relative to placebo alters : (1a) impulsivity; (1b) mood; and (1c) physiology. Aim 2 will determine whether active rTMS over the medial prefrontal cortex alters the effects of stress-exposure on (2a) decision-making, (2b) mood, and (2c) biomarkers of stress.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• 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 must be within ranges that allow for safe use of 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 (excluding marijuana) based on Timeline Followback interview

• Urine positive for opioids, cocaine metabolites, benzodiazepines, barbiturates, amphetamines or pregnancy

• Medical conditions prohibiting use of rTMS (e.g. seizure history; using validated rTMS screening instrument)

• Lifetime diagnosis of: psychotic disorder, bipolar disorder, generalized anxiety disorder, obsessive compulsive disorder, or major depression that is not substance-induced

• Past-year substance use disorder

• Medical 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

• Taken part in any research studies in the past month