Overview

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

Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wayne State University
Treatments:
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Yohimbine
Criteria
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.