NCT04432064

Temporal Interference Neurostimulation and Addiction

Terminated NA Results posted Last updated 24 June 2025

What this trial tests

NA trial testing Active TI-NDBS in Nicotine Use Disorder in 10 participants. Terminated before completion.

Timeline

6 July 2020

Primary endpoint
21 April 2022

21 April 2022

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	10
Start date	6 July 2020
Primary completion	21 April 2022
Estimated completion	21 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Active TI-NDBS
• Sham TI-NDBS
• tDCS — full drug profile →

Conditions studied

• Nicotine Use Disorder — all drugs for Nicotine Use Disorder →
• Substance Use Disorders — all drugs for Substance Use Disorders →

Sponsor

Indiana University

Who can join

Adults 18 to 50, any sex, with Nicotine Use Disorder or Substance Use Disorders. 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.

Change in Nicotine Craving Primary · Each subject was asked to report their craving during the day of the session, before and after the stimulation. Approximately one hour elapsed between before and after nicotine craving measurements. The session was carried out during the daytime.

The investigators predict that TI-NDBS will outperform sham stimulation at an overall change in smoking and cigarette craving, which in turn will outperform sham stimulation. The investigators will sum the total inhaled nicotine vapor volume in liters over the 60 minute session and perform pairwise t-tests to determine if total drug intake is lower with TI-NDBS vs tDCS. Also, the investigators will average the self reported craving levels on a Likert scale across each subject during the 60 minute session, and the investigators will perform pairwise tests to determine if stimulation lowers self

Group	Value	95% CI
Phase 3 Active TI-NDBS	4.25	± 1.71

Adverse events — posted to ClinicalTrials.gov

Time frame: The total duration of collecting information about adverse events across subjects was 1 year, 5 months. Each individual subject was monitored for adverse events over a one day period.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 3 Active TI-NDBS

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (1 terms — click to expand)

Reaction	System	Phase 3 Active TI-NDBS
Unpleasant sensation	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT04432064 adverse events section.

Sponsor's own description

This project aims to develop a line of research using new non-invasive neurostimulation technology to treat adults with opioid use disorders (OUDs). In the short term, the investigators aim to identify novel target brain regions for neurostimulation treatment and characterize their effects behaviorally and neurally. In the longer term, investigators aim to use these preliminary data to justify NIH sponsored clinical trials to apply transcranial direct current stimulation and non-invasive deep brain stimulation to these areas to partially or completely disrupt addiction.

Publications & conference data

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

1. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
   Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991