Using Combined EEG and Non-invasive Brain Stimulation to Examine and Improve Reward Functioning in Opioid Use Disorder

NCT04432493 | Completed Results FDA Device

• 1 other identifier: Pro2018002739
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aims of this study are to identify impaired cognitive control in opioid use disorder (OUD) and subsequently to examine the effects of transcranial magnetic stimulation (TMS) on reward processing, as measured by the reward positivity (an electrophysiological signal) in people with OUD. To this end, the investigators will adopt a randomized sham-controlled trial to evaluate the efficacy of Ri-TMS on cognitive control in OUD. The investigators hypothesize that Ri-TMS will be successful in modulating the reward positivity in opioid users in the active TMS condition.

Conditions

Opioid-use Disorder

Keywords

Transcranial magnetic stimulation; Reward processing; Cognitive control

Outcome Measures

Primary Outcomes (1)

• Reward Positivity

  The reward positivity is an event-related brain potential, sensitive to reward feedback. The reward positivity will be measured during the t-maze task, where participants will receive feedback on choices (Reward, No-reward). Reward positivity amplitude will be determined by identifying the maximum absolute amplitude of the difference wave within a 200- to 400-ms window following feedback onset. The reward positivity will be evaluated along front-central electrodes (Fz, FCz, Cz).

  Day 0 (day of testing)

Study Arms (4)

Active TMS - OUD

EXPERIMENTAL

Participants in the opioid used disorder group (OUD) in the active condition will receive repetitive TMS (rTMS), delivered at 110% of participants' resting motor threshold at 10 Hz continuously over the predefined DLFPC target for a total of 2000 pulses

Device: Active repetitive transcranial magnetic stimulation (rTMS)

Sham TMS - OUD

PLACEBO COMPARATOR

Identical parameters will be applied to the opioid used disorder (OUD) SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation

Device: Sham repetitive transcranial magnetic stimulation (rTMS)

Active TMS - HC

ACTIVE COMPARATOR

Healthy Control (HC) participants in the active condition will receive repetitive TMS (rTMS), delivered at 110% of participants' resting motor threshold at 10 Hz continuously over the predefined DLFPC target for a total of 2000 pulses

Device: Active repetitive transcranial magnetic stimulation (rTMS)

Sham TMS - HC

SHAM COMPARATOR

Identical parameters will be applied to the healthy control (HC) SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation

Device: Sham repetitive transcranial magnetic stimulation (rTMS)

Interventions

Active repetitive transcranial magnetic stimulation (rTMS) DEVICE

rTMS will be used to stimulate neuronal activity of the dorsolateral prefrontal cortex (DLPFC). Participants will receive no more than 2000 pulses of rTMS at 110% of participants' resting motor threshold at 10 Hz continuously for the duration of the t-maze task.

Active TMS - HC; Active TMS - OUD

Sham repetitive transcranial magnetic stimulation (rTMS) DEVICE

Sham TMS will be used to mimic the auditory sensation of the Active rTMS condition. Protocols for the sham condition will be the same as the active condition, however the TMS coil will be flipped 180 degrees so that participants in this condition will not receive any active stimulation.

Sham TMS - HC; Sham TMS - OUD

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Native English speakers
• Males and Females aged 18-55 years old
• Ability to provide informed written or verbal consent
• Opioid dependent individuals (according to the Alcohol, Smoking and Substance Involvement Screening Test opioid dependence score), or
• Healthy controls with no history of significant substance use

You may not qualify if:

• Un-correctable visual impairment
• Uninterruptable central nervous system medication
• TMS contraindications (e.g., pregnancy, braces, history of seizures, metal implants).
• History of neurological or psychiatric illness
• Diagnosed learning disability
• History of significant head injury (loss of consciousness for more than five minutes)
• Substance abuse (Participants who score above 39.5 on the Global Continuum of Substance Risk scale of the Alcohol, Smoking and Substance Involvement Screening Test - controls only)
• Use of psychoactive or vasoactive medications

Sponsors & Collaborators

• Rutgers University: lead

Study Sites (1)

Rutgers University - Newark

Newark, New Jersey, 07102, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Travis Baker, PhD
• Organization: Rutgers University

travis.e.baker@rutgers.edu

18622503351

Study Officials

• Kathryn Biernacki, PhD

  Rutgers University - Newark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded as to TMS condition (active or sham)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 16, 2020
• Study Start: February 20, 2020
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: March 8, 2024
• Results First Posted: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)