NCT03352609

Accelerated rTMS for the Reduction of Nicotine Craving

Terminated NA Results posted Last updated 15 October 2019

What this trial tests

NA trial testing Active rTMS with MagVenture MagPro double blind rTMS system in Nicotine Use Disorder in 5 participants. Terminated before completion.

Timeline

1 January 2018

Primary endpoint
12 December 2018

12 December 2018

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	5
Start date	1 January 2018
Primary completion	12 December 2018
Estimated completion	12 December 2018
Sites	1 location across United States

Drugs / interventions tested

• Active rTMS with MagVenture MagPro double blind rTMS system
• Sham rTMS

Conditions studied

• Nicotine Use Disorder — all drugs for Nicotine Use Disorder →
• Nicotine Dependence — all drugs for Nicotine Dependence →

Sponsor

Medical University of South Carolina

Who can join

Adults 18 to 70, any sex, with Nicotine Use Disorder or Nicotine Dependence. 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.

Tolerability Measured by Percent of Participants Completing the rTMS Course Primary · 1 day (single visit)

Percent of participants completing the 5 session rTMS course. Hypothesize \>75% of participants will complete the 5 treatments.

Group	Value	95% CI
Active rTMS	2
Sham	3

Decrease in Cue Induced Nicotine Craving Primary · During the one day visit

Nicotine craving evaluated using Questionnaire on Smoking Urges- Brief (QSU-B) questions modified to a 0-100 analog rating. Higher scores meaning a higher level of craving.

Group	Value	95% CI
Active rTMS	-4.65	-10 – 0.7
Sham	-7.6	-21.3 – 3.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Single visit of approximately 6 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active rTMS

Serious: 0/2 (0%)

Deaths: 0/2

Sham

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (2 terms — click to expand)

Reaction	System	Active rTMS	Sham
Slight scalp discomfort	Skin and subcutaneous tissue disorders	—	—
Mild Nausea	General disorders	—	—

Data from ClinicalTrials.gov NCT03352609 adverse events section.

Sponsor's own description

The purpose if this study is to determine if five treatments of repetitive transcranial magnetic stimulation (rTMS) can reduce craving for cigarettes in smokers. rTMS uses magnetic pulses to stimulate the brain and is currently approved for the treatment of major depressive disorder.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tolerability and feasibility of accelerated repetitive transcranial stimulation for reduction of nicotine craving.
   Friedrich D, Li X, Hartwell KJ, Short EB, et al · · 2019 · cited 2× · PMID 31253502 · DOI 10.1016/j.brs.2019.06.023
2. 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