Effects of Pharmacological Stress and rTMS on Executive Function in Opioid Use Disorder

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Wayne State University
Study ID
NCT04231708
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
21 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Yohimbine + Hydrocortisone — DRUG
    Yohimbine (54mg bulk powder inside capsule) administered in combination with Hydrocortisone (20mg tablet inside capsule)
  • Active rTMS — DEVICE
    10Hz rTMS over the left dlPFC
  • Placebo — DRUG
    lactose (inside capsule)
  • Sham rTMS — DEVICE
    inactive stimulation over the left dlPFC

Study Details

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.

Key Dates

Start date
Oct 31, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: placebo stressor, sham rTMS
    Placebo stressor (lactose) + sham (inactive) rTMS over the left dlPFC
  • Experimental: placebo stressor, active rTMS
    Placebo stressor (lactose) + active 10Hz rTMS over the left dlPFC
  • Experimental: active stressor, sham rTMS
    Stressor (yohimbine 54mg + hydrocortisone 20mg) + sham (inactive) rTMS over the left dlPFC
  • Experimental: active stressor, active rTMS
    Stressor (yohimbine 54mg + hydrocortisone 20mg) + active 10Hz rTMS over the left dlPFC

Primary Outcome Measure

Color-Word Stroop Task [ Time Frame: change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tolan Park Medical BuildingDetroitMichigan48201-

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By research site
Tolan Park Medical Building· Detroit, MI

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