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Frontal-Striatal Reward Circuit Neuromodulation and Alcohol Self-Administration

NCT04971681 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-01-13

Study results available
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Summary

This will be a single site randomized, 2-session, within-subject cross-over design pilot study. 20 enrolled (of 30 consented) subjects reporting varying levels of binge and high intensity drinking, defined as at least 2 episodes of drinking 4 (for women) or 5 (for men) drinks on an occasion over the last 5 weeks, (unless determined by PI that drinking history meets study objectives), will be enrolled. Subjects will be randomized to undergo one session of repetitive transcranial magnetic stimulation (rTMS) or sham immediately followed by the investigators rate control intravenous (IV) alcohol self-administration (ASA) paradigm. Subjects will then return 7-14 days later and undergo the same sequence of events with the opposite intervention (i.e. rTMS or sham) from session 1.

Conditions

Interventions

DEVICE

Low frequency repetitive transcranial magnetic stimulation (rTMS)

Subjects will receive one session of low frequency repetitive transcranial magnetic stimulation (rTMS) targeting the medial prefrontal cortex (mPFC), within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 110% of motor threshold (MT), for a total of 1200 pulses

DEVICE

Sham

The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Indiana University

    lead OTHER

Principal Investigators

  • Susan Conroy, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2022-04-25
Completion
2022-06-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04971681 on ClinicalTrials.gov