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Stress Pharmacotherapy + rTMS for Opioid Use Disorder

Phase 2

Waitlist Available

Research Sponsored by Wayne State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 21-60 yr

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

Must not have

Medical conditions prohibiting use of rTMS (e.g. seizure history; based on rTMS screening questionnaire)

Any prohibited medications: medications that lower seizure threshold, psychiatric medications, prescription pain medications, or blood pressure medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)

Summary

This trial is designed to see if stress impacts domains of behavior in individuals with opioid use disorder, and whether transcranial magnetic stimulation (TMS) can help attenuate negative effects of stress.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects may include discomfort at the rTMS application site on the scalp, headache or lightheadedness post-treatment. The pharmacological stress might cause increased heart rate or anxiety temporarily.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 60 years old.

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My heart rate and blood pressure are within safe ranges.

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I am a male or a female not currently pregnant or breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have medical conditions that prevent me from using rTMS.

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I am not taking medications that lower seizure threshold, psychiatric drugs, prescription painkillers, or blood pressure medications.

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I have ongoing pain in my head or neck.

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I do not have any severe illnesses that would make it unsafe for me to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) for reporting.