NCT04971681

Frontal-Striatal Reward Circuit Neuromodulation and Alcohol Self-Administration

Terminated NA Results posted Last updated 13 January 2025

What this trial tests

NA trial testing Low frequency repetitive transcranial magnetic stimulation (rTMS) in Alcohol Use Disorder in 9 participants. Terminated before completion.

Timeline

8 October 2021

Primary endpoint
25 April 2022

2 June 2022

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	9
Start date	8 October 2021
Primary completion	25 April 2022
Estimated completion	2 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Low frequency repetitive transcranial magnetic stimulation (rTMS)
• Sham

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

Indiana University

Who can join

Adults 21 to 35, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

T80 Primary · 90 min

The amount of time subjects take to self-administer enough alcohol to raise their breath alcohol concentration (BrAC) to 80 mg/dL

Group	Value	95% CI
Low Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)	61.5	± 9.4
Sham rTMS Stimulation	71.6	± 8.0

Alcohol Consumption (Drinks/Week) Secondary · 5 weeks

Alcohol consumption as measured by Time Line Follow Back (TLFB) comparing drinking baseline (5 weeks prior to study) with post-treatment during the 5-week follow-up period. The Timeline Follow-back (TLFB) is uses a calendar to assess a subject's retrospective estimates of their daily drinking.

Group	Value	95% CI
Low Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)	14.8	± 4.9
Sham rTMS Stimulation	7.8	± 3.5

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Trends of Brain Stimulation Research in Substance Use Disorder: A Review of ClinicalTrials.gov Registered Trials and Their Publications.
   Biswas T, Singh GK, Mishra P, Mishra BR, et al · · 2026 · cited 1× · PMID 39677515 · DOI 10.1177/02537176241300195