tDCS to Decrease Opioid Relapse (UH3)

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Butler Hospital
Study ID
NCT06432465
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
21 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • active tDCS — DEVICE
    The anode will be placed over the right DLPFC (F4 on the EEG 10-20 system) and the cathode over the left DLPFC65 (F3) using 25cm2 sponges at an intensity of 2mA. Stimulation will be delivered for 20 minutes via two saline-soaked surface sponge electrodes and a battery-driven, constant current stimulator (NeuroConn DC Stimulator Plus).
  • sham tDCS — DEVICE
    Same device and procedures as active tDCS with the exception that the device includes a study mode, in which subject-specific codes are entered to deliver active or sham stimulation, keeping the administrator blinded. Sham stimulation will use a method in which stimulation will be ramped up and back down over a 30-second period at the beginning and end of sham tDCS.

Study Details

Investigators will measure behavioral and brain responses following transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (DLPFC) (anode on right DLPFC, cathode on the left DLPFC) delivered during cognitive control network (CCN) priming. In Phase I, the EEG provided validation of expected changes in these networks following tDCS stimulation of the DLPFC. In this current phase (II), the investigators will perform a larger randomized clinical trial (RCT) (active vs. sham control) to address long-term neurobehavioral outcomes, including opioid relapse, craving, and sustained EEG changes.

Key Dates

Start date
Apr 17, 2024
Status verified
Dec 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: active tDCS
    Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
  • Sham Comparator: sham tDCS
    Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.

Primary Outcome Measure

Opioid Craving [ Time Frame: 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Butler HospitalProvidenceRhode Island02906
Ana M Abrantes, Ph.D.
[email protected]
401-455-6440
Ana M. Abrantes, Ph.D. (PRINCIPAL_INVESTIGATOR)
Michael Stein, M.D. (PRINCIPAL_INVESTIGATOR)

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Butler Hospital· Providence, RI

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