Stress Pharmacotherapy + rTMS for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Wayne State University

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This preliminary study is designed to evaluate mechanisms by which excitatory dorsolateral prefrontal cortex (dlPFC) repetitive transcranial magnetic stimulation (rTMS) (vs. sham) and pharmacological stress (vs. placebo) alter behavior in non-treatment seeking individuals with opioid use disorder (OUD). Specific Aims are to (1) Evaluate how stress impacts domains of behavior including (1a) executive function and (1b) opioid-seeking behavior; and (2) Determine whether rTMS stimulation attenuates (2a) executive dysfunction, (2b) stress-reactivity, and (2c) opioid-seeking in individuals with OUD not receiving treatment.

Eligibility Criteria

This trial is for right-handed individuals aged 21-60 with opioid use disorder who are not seeking treatment. They must have a stable heart rate and blood pressure, consume alcohol or marijuana minimally, and be cognitively intact. Exclusions include pregnancy, certain drug use, seizure history, unstable illnesses, lactose intolerance, recent participation in other studies, and specific mental health diagnoses.

Inclusion Criteria

Right handed

You have been diagnosed with opioid use disorder according to the DSM-5 guidelines.

I am between 21 and 60 years old.

See 4 more

Exclusion Criteria

You are not allowed to be under the influence of any drugs or alcohol during the session.

Past-month participation in a research study.

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

See 8 more

Treatment Details

Interventions

Active rTMS (Repetitive Transcranial Magnetic Stimulation)
Placebo (Placebo)
Sham rTMS (Repetitive Transcranial Magnetic Stimulation)
Yohimbine + Hydrocortisone (Pharmacological Stressor)

Trial OverviewThe study tests how rTMS (a non-invasive brain stimulation) versus sham (fake treatment) combined with pharmacological stress (using Yohimbine + Hydrocortisone vs placebo) affects executive function and opioid-seeking behavior in people with OUD. It aims to see if rTMS can reduce the negative effects of stress on behavior.

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: placebo stressor, active rTMSExperimental Treatment2 Interventions

Placebo stressor (lactose) + active 10Hz rTMS over the left dlPFC

Group II: active stressor, sham rTMSExperimental Treatment2 Interventions

Stressor (yohimbine 54mg + hydrocortisone 20mg) + sham (inactive) rTMS over the left dlPFC

Group III: active stressor, active rTMSExperimental Treatment2 Interventions

Stressor (yohimbine 54mg + hydrocortisone 20mg) + active 10Hz rTMS over the left dlPFC

Group IV: placebo stressor, sham rTMSPlacebo Group2 Interventions

Placebo stressor (lactose) + sham (inactive) rTMS over the left dlPFC