N/A
N=81
Using Combined EEG and Non-invasive Brain Stimulation to Examine and Improve Reward Functioning in Opioid Use Disorder
Opioid-use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04432493 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Reward Positivity — -5.2; -2.3; -4.4; -4.6 μV (microvolts)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active repetitive transcranial magnetic stimulation (rTMS) (Device); Sham repetitive transcranial magnetic stimulation (rTMS) (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers University
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reward Positivity |
-5.2; -2.3; -4.4; -4.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04432493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.