Using brain stimulation to reduce opioid relapse

tDCS to Decrease Opioid Relapse (UH3)

This study is testing if a brain stimulation technique can help people who are trying to overcome opioid addiction by reducing cravings and preventing relapse while they are on treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 21 Years to 60 Years
• Sex: All
• Sponsor: Butler Hospital (other)
• Locations: 1 site (Providence, Rhode Island)
• Trial ID: NCT06432465 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of transcranial direct current stimulation (tDCS) on opioid-dependent individuals who have recently started treatment with buprenorphine or methadone. Participants will be randomly assigned to receive either active tDCS combined with cognitive control network priming or a sham treatment over five sessions. The study aims to assess long-term neurobehavioral outcomes, including rates of opioid relapse and craving, using electroencephalographic (EEG) measurements at multiple time points. The goal is to understand how tDCS can influence brain activity related to craving and cognitive control in this population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-60 who are currently opioid dependent and have recently initiated treatment with buprenorphine or methadone.

Not a fit: Patients with severe psychiatric disorders, significant neurocognitive dysfunction, or other contraindications to tDCS may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of relapse in patients with opioid use disorder.

How similar studies have performed: Previous studies have shown promise in using brain stimulation techniques for addiction treatment, but this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. current opioid dependence
2. between 21-60 years of age
3. recent initiation of buprenorphine or methadone (≤30days)
4. enrolled in Butler Hospital's Alcohol and Drug Inpatient Unit, Alcohol and Drug Partial Hospital Treatment Program, Intensive Outpatient Services, or Outpatient Services at Butler Hospital OR receive opioid-treatment services in the community.

Exclusion Criteria:

1. current diagnosis of organic brain disorder (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis, intracranial mass/infection, hydrocephalus)
2. bipolar, schizophrenia, schizoaffective, or schizophreniform disorder, or current psychosis associated with any disorder
3. current suicidality
4. evidence of significant neurocognitive dysfunction
5. conditions associated with heightened tDCS risks, e.g., seizure disorder, nonremovable intracranial metal objects (other than dental fillings and dental implants), skin disease or active lesions on the scalp, migraine/other headache disorder with significant active symptoms, traumatic brain injury or skull fracture within the past year, any implanted medical devices or device components that can interact with electromagnetic fields or are controlled by physiological signals
6. probation/parole requirements or an upcoming move that might interfere with protocol participation
7. planning to terminate buprenorphine or methadone in less than 3 months
8. current pregnancy or plan to become pregnant in the next month.

Where this trial is running

Providence, Rhode Island

• Butler Hospital — Providence, Rhode Island, United States (RECRUITING)

Study contacts

• Principal investigator: Abrantes Abrantes, Ph.D. — Butler Hospital
• Study coordinator: Ana M Abrantes, Ph.D.

Conditions: Opioid Use Disorder, opioid craving, buprenorphine, methadone, EEG, transcranial direct current stimulation