Overview

Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders

Status:
Recruiting

Trial end date:
2022-09-01

Target enrollment:
0

Participant gender:
All

Summary

Subjects in this study will be patients with opioid use disorders (OUDs) based on DSM-5 criteria recruited from the greater Atlanta metropolitan region. Recruitment will be from treatment programs in the greater Atlanta Metropolitan Region including the DeKalb Community Service Board residential, detoxification and other treatment programs which with over 30,000 patient visits per year represents the largest treatment program in one of two urban counties in greater Atlanta. This trial involves a second phase after completing an exploratory study in 20 patients with OUDs to assess different timing parameters of nVNS effects on sympathetic measures and symptoms of craving, as well as modelling to verify and iteratively refine the methods for vagal nerve stimulation. The investigators in this trial will then apply nVNS comparing active (N=10) to sham (N=10) in OUD patients recently started on medication, looking at opioid craving, brain functional response with HR-PET, and cardiovascular and inflammatory biomarker responses to imagery-induced opioid drug craving.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Emory University

Collaborators:

CUNY
Georgia Institute of Technology
National Institute on Drug Abuse (NIDA)

Criteria

Inclusion Criteria:

- Inclusion Criteria:

Subjects aged 18 and over who meet criteria for OUDs based on the Structured Clinical
Interview for DSM-5 (SCID) interview and are stable on medication treatment.

Exclusion Criteria:

1. Positive pregnancy test

2. Meningitis

3. Traumatic brain injury

4. Neurological disorder or organic mental disorder

5. History of loss of consciousness greater than one minute

6. Current pregnancy or breastfeeding for women

7. Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia,
based on the SCID

8. A history of serious medical or neurological illness, such as cardiovascular,
gastrointestinal, hepatic, renal, neurologic or other systemic illness

9. Evidence of a major medical or neurological illness that is based on the clinical
judgment of the study psychiatrist

10. Active implantable device (i.e. pacemaker)

11. Carotid atherosclerosis

12. Cervical vagotomy