## Protocol Section
### Identification Module
**NCT ID:** NCT06432465

**Brief Title:** tDCS to Decrease Opioid Relapse (UH3)

**Official Title:** tDCS to Decrease Opioid Relapse (UH3)

#### Organization Study ID Info
**ID:** 1317333
#### Organization
**Class:** OTHER
**Full Name:** Butler Hospital
#### Secondary ID Infos
**ID:** 4UH3DA047793
**Link:** https://reporter.nih.gov/quickSearch/4UH3DA047793
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-17

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute on Drug Abuse (NIDA)

#### Lead Sponsor

**Class:** OTHER

**Name:** Butler Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

**Detailed Description:** Investigators will perform an RCT in 100 opioid dependent participants who recently initiated buprenorphine or methadone. Participants will be randomized to receive five sessions of tDCS+CCN priming stimulation vs. sham tDCS+CCN priming. Participants will be assessed three times using electroencephalographic (EEG), once prior to tDCS+CCN priming, right after the completion of 5 sessions of tDCS+CCN priming (one week later), and again 10 weeks later.

This phase will address long-term (3- and 6-month) neurobehavioral outcomes, including opioid relapse, craving, and sustained EEG changes during a paradigm that challenges networks associated with craving (CR) and cognitive control (CCN). During the 24 weeks of buprenorphine or methadone maintenance treatment, the investigators will examine our primary clinical outcome, relapse (opioid use on \>4 days per month and having an opioid positive urine screen), as well as days of opioid use.

### Conditions Module

**Conditions:**

- Opioid Use Disorder

**Keywords:**

- opioid craving

- buprenorphine

- methadone

- EEG

- transcranial direct current stimulation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: tDCS

**Label:** tDCS

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Device: tDCS

**Label:** sham tDCS

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- sham tDCS

- tDCS

**Description:** 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 via two saline-soaked surface sponge electrodes and a battery-driven, constant current stimulator (NeuroConn DC Stimulator Plus). This 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.

**Name:** tDCS

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Penn Alcohol Craving (Modified for Opioids) (scoring: 0 - 30, higher scores = more craving)

Penn Alcohol Craving (Modified for Opioids) (scoring: 0 - 30, higher scores = more craving)

Penn Alcohol Craving (Modified for Opioids) (scoring: 0-30, higher scores = more craving)

**Measure:** Changes in opioid craving

**Time Frame:** 2 weeks

**Description:** frontal theta activity during working memory

**Measure:** change in EEG oscillatory targets

**Time Frame:** 2 weeks

**Description:** Timeline followback interview and urine toxicology

**Measure:** lower rates of opioid relapse

**Time Frame:** 24 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

(a) current opioid dependence, (b) between 21-60 years of age, (c) recent initiation of buprenorphine or methadone (≤30days), and (d) 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:

(a) current diagnosis of organic brain disorder (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis, intracranial mass/infection, hydrocephalus), (b) bipolar, schizophrenia, schizoaffective, or schizophreniform disorder, or current psychosis associated with any disorder, (c) current suicidality, (d) evidence of significant neurocognitive dysfunction, (e) 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, (f) probation/parole requirements or an upcoming move that might interfere with protocol participation, (g) planning to terminate buprenorphine or methadone in less than 3 months, (h) current pregnancy or plan to become pregnant in the next month.

**Maximum Age:** 60 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ana_abrantes@brown.edu

**Name:** Ana M Abrantes, Ph.D.

**Phone:** 4014556440

**Role:** CONTACT

**Contact 2:**

**Email:** jdesaulniers@butler.org

**Name:** Julie A Desaulniers, M.S.

**Phone:** 4014556219

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Providence

**Contacts:**

***Contact 1:***

- **Email:** ana_abrantes@brown.edu

- **Name:** Ana M Abrantes, Ph.D.

- **Phone:** 401-455-6440

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ana M. Abrantes, Ph.D.

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Michael Stein, M.D.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Butler Hospital

**State:** Rhode Island

**Status:** RECRUITING

**Zip:** 02906

#### Overall Officials

**Official 1:**

**Affiliation:** Butler Hospital

**Name:** Abrantes Abrantes, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Boston University

**Name:** Michael Stein, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000079524

- Term: Narcotic-Related Disorders

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12244

- Name: Opioid-Related Disorders

- Relevance: HIGH

- As Found: Opioid Use Disorder

- ID: M2057

- Name: Narcotic-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009293

- Term: Opioid-Related Disorders

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: NarcAntag

- Name: Narcotic Antagonists

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnTuAg

- Name: Antitussive Agents

- Abbrev: Resp

- Name: Respiratory System Agents

### Intervention Browse Module - Browse Leaves

- ID: M5317

- Name: Buprenorphine

- Relevance: LOW

- As Found: Unknown

- ID: M11671

- Name: Methadone

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
