Who is eligible for clinical trial NCT04231708?

Participants must meet protocol criteria for Opioid Use Disorder. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04231708 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-12-26

Effects of Pharmacological Stress and rTMS on Executive Function in Opioid Use Disorder (NCT04231708)

🟡 Not Yet Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Wayne State University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (12 items).

Location: Tolan Park Medical Building — Detroit, Michigan

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Tolan Park Medical Building — Detroit, Michigan

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗