rTMS-concurrent Behavioral Priming for Reducing Smoking Cravings

Summary

The objective of this pilot clinical trial is to test the effects of different types of thinking strategies at the time of repetitive Transcranial Magnetic Stimulation (rTMS), applied to the left Dorsolateral Prefrontal Cortex (DLPFC), on smoking craving and brain activity. Participants will be individuals with moderate to high smoking dependence (smoking at least 8 cigarettes a day) who have no intention of quitting in the next 3 months and are eligible to have rTMS and functional magnetic resonance imaging (fMRI). The main objectives of the trial are:

1. To compare the craving-reducing effects of "upregulation" and "downregulation" of craving while looking at pictures related to cigarette smoking during rTMS versus no regulation of craving while looking at neutral pictures unrelated to smoking. 'Upregulation" is thinking about the immediate positive experience of smoking. "Downregulation" is thinking about the long-term negative consequences of smoking.
2. To examine changes in brain activity that accompany craving reductions produced by rTMS paired with upregulation and downregulation of craving while looking at pictures related to cigarette smoking versus no regulation of craving while looking at neutral pictures unrelated to smoking.

Following screening for eligibility, participants will be trained on how to do upregulation and downregulation of craving. The participants will then participate in 3 testing sessions. In each session, the participants will receive rTMS at 20Hz in 50 trains (2000 pulses total), followed immediately by fMRI. Sessions will take place 1-2 weeks apart and will differ in the type of thinking strategy participants will use while looking at pictures during the rTMS:

* upregulation of craving while viewing smoking-related images
* downregulation of craving while viewing smoking-related images
* no regulation of craving while viewing neutral smoking-unrelated images

The order of sessions will be randomized across participants.

Conditions

• Smoking Reduction
• Smoking Behaviors

Interventions

DEVICE

Repetitive transcranial magnetic stimulation (rTMS)

rTMS: rTMS is a form of non-invasive brain modulation. High-frequency rTMS will be administered. Pulses will be delivered at the frequency of 20Hz, in 50 trains of 40 pulses, 2000 pulses in total. Behavioral priming with regulation of craving: During rTMS, participants will look at pictures either related or unrelated to smoking. When looking at pictures related to smoking, participants will either upregulate cravings by thinking about the immediate positive experience of smoking or downregulate cravings by thinking about long-term negative consequences of smoking. When looking at neutral pictures unrelated to smoking, participants will not regulate their cravings.

Sponsors & Collaborators

• West Virginia University

  lead OTHER

Principal Investigators

• Mariya V Cherkasova, PhD · West Virginia University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-16

Primary Completion

2026-05-31

Completion

2026-05-31

FDA Device

Yes

Countries

• United States

Study Locations