tDCS to Decrease Opioid Relapse (UG3)

NCT03842137 | Completed Results DMC FDA Device

• 2 other identifiers: 1810-001UG3DA047793
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

In the current proposal, the 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. Participants with opioid dependence, in the first month of prescribed buprenorphine or methadone, will be assessed twice using electroencephalographic (EEG), once prior to tDCS+CCN priming and again at the completion of 5 sessions of tDCS+CCN priming (one week later). EEG will provide validation of expected changes in these networks following tDCS stimulation of the DLPFC.

Conditions

Opioid Dependence; Craving

Outcome Measures

Primary Outcomes (1)

• Opioid Craving

  Penn Alcohol Craving (Modified for Opioids). This is a 5-item measure, with each item scored 0 to 6. Items are summed for a total score from 0 to 30. Higher scores = more craving.

  2 week

Secondary Outcomes (1)

• EEG Theta Brainwave Activity

  2 weeks

Study Arms (2)

tDCS

ACTIVE COMPARATOR

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.

Device: tDCS

sham tDCS

SHAM COMPARATOR

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.

Device: sham tDCS

Interventions

tDCS DEVICE

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.

tDCS

sham tDCS DEVICE

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.

sham tDCS

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• current opioid dependence
• between 21-50 years of age
• recent initiation of buprenorphine or methadone (\<30 days)

You may not qualify if:

• current criteria for a DSM-V diagnosis of bipolar disorder, schizophrenia, schizo-affective, schizophreniform, or paranoid disorder
• current suicidality
• evidence of neurocognitive dysfunction
• contraindications for tDCS (e.g seizure disorder)
• probation/parole requirements or an upcoming move that might interfere with protocol participation
• planning to terminate buprenorphine in less than 3 months
• scalp lesions near the tDCS electrode sites

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Ana M. Abrantes, Ph.D.
• Organization: Butler Hospital

aabrantes@carene.org

401-455-6440

Study Officials

• Ana M Abrantes, Ph.D.

  Butler Hospital

  PRINCIPAL INVESTIGATOR

• Michael D Stein, M.D.

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: June 4, 2019
• Primary Completion: April 30, 2023
• Study Completion: August 31, 2023
• Last Updated: October 24, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-10

Locations

US (1)