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

NCT ID: NCT04231708

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-10-31

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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This study will use a double-blind, 10Hz left dlPFC rTMS (vs. sham) and pharmacological stressor (\[yohimbine + hydrocortisone\] vs. placebo) within-subject, randomized crossover design. Each participant will complete 4 sessions (stressor vs. placebo, crossed with rTMS vs. sham), each separated by at least 1 week. Participants will complete these 4 (2x2 within subject) test conditions in randomized order: sham rTMS/placebo stress, sham rTMS/active stress, active rTMS/ placebo stress, and active rTMS/active stress.

The PI will perform randomization using a Latin Square and will assign participants to conditions and prepare medication (stressor or placebo) for each participant's sessions. The PI will keep others blinded and will not be involved in study assessments.

Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double-blind, 10Hz left dlPFC rTMS (vs. sham) X pharmacological stressor (vs. placebo) within-subject, randomized crossover design.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Placebo (lactose) for pharmacological stressor, and sham for dlPFC rTMS

Study Groups

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placebo stressor, sham rTMS

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

lactose (inside capsule)

Sham rTMS

Intervention Type DEVICE

inactive stimulation over the left dlPFC

placebo stressor, active rTMS

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

Group Type EXPERIMENTAL

Active rTMS

Intervention Type DEVICE

10Hz rTMS over the left dlPFC

Placebo

Intervention Type DRUG

lactose (inside capsule)

active stressor, sham rTMS

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

Group Type EXPERIMENTAL

Yohimbine + Hydrocortisone

Intervention Type DRUG

Yohimbine (54mg bulk powder inside capsule) administered in combination with Hydrocortisone (20mg tablet inside capsule)

Sham rTMS

Intervention Type DEVICE

inactive stimulation over the left dlPFC

active stressor, active rTMS

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

Group Type EXPERIMENTAL

Yohimbine + Hydrocortisone

Intervention Type DRUG

Yohimbine (54mg bulk powder inside capsule) administered in combination with Hydrocortisone (20mg tablet inside capsule)

Active rTMS

Intervention Type DEVICE

10Hz rTMS over the left dlPFC

Interventions

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Yohimbine + Hydrocortisone

Yohimbine (54mg bulk powder inside capsule) administered in combination with Hydrocortisone (20mg tablet inside capsule)

Intervention Type DRUG

Active rTMS

10Hz rTMS over the left dlPFC

Intervention Type DEVICE

Placebo

lactose (inside capsule)

Intervention Type DRUG

Sham rTMS

inactive stimulation over the left dlPFC

Intervention Type DEVICE

Eligibility Criteria

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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; and
* Past-month participation in a research study.
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wayne State University

OTHER

Sponsor Role lead

Responsible Party

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Mark Greenwald, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tolan Park Medical Building

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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DL-STR-OUD

Identifier Type: -

Identifier Source: org_study_id