Health TrialsbyHealthPanel

Personalized Brain Stimulation to Help Veterans Quit Smoking

ConditionsTabacco Use DisorderrTMS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorVA Office of Research and Development

About this trial

Cigarette smoking is a significant public health concern for Veterans. Encouraging smoking cessation continues to be a top priority for the Veterans' Administration as Veterans who use tobacco experience negative health effects, including cancer, heart disease, and mental disorders. Despite the efficacy of current evidence-based pharmacotherapies and psychotherapies for smoking cessation, alternative treatments are critically needed. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive form of brain stimulation, US FDA-approved for smoking cessation. In this protocol, the investigators propose comparing the two rTMS protocols (standard TMS vs. precision TMS) to find a better treatment parameter for smoking cessation in Veterans. Identifying an efficacious rTMS protocol would benefit Veterans who want to quit smoking.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Veteran

Individuals who smoke 10 or more cigarettes per day and have a CO level > 10 ppm indicative of recent smoking

Those who have not received substance abuse treatment within the previous 30 days

Those who have been stable on psychotropic medications for at least three months

Disqualifiers

Current moderate to severe substance use of any psychoactive substances other than nicotine or caffeine, as defined by DSM-V criteria

Contraindications to MRI (e.g., metal in the skull, orbital or intracranial cavity, or claustrophobia)

Contraindications to rTMS (history of a seizure or epilepsy)

A history of autoimmune, endocrine, viral, or vascular disorders affecting the brain

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial Magnetic Stimulation

    Device

    The first group will receive 10 Hz DTMS (standard TMS) with a protocol of 3 seconds on, 15 seconds off, and a total of 1800 pulses/session, lasting 18 minutes, targeting the bilateral insula and lateral prefrontal cortex.

  • Personalized-image-guided and E-field-modeling dose rTMS (precision TMS)

    Device

    With a protocol of 5 seconds on, 10 seconds off, and a total of 3000 pulses/session, lasting 15 minutes, targeting the left DLPFC.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Deep rTMSActive comparator 1 intervention
Group B: Precision TMSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cigarettes per day (CPD)

The investigators will compare the reduction of cigarette consumption between the two treatment groups at the end of the 3-week Repetitive Transcranial Magnetic Stimulation (rTMS) treatment. A higher reduction of CPD means a better treatment result.

Time frame
The cigarettes per day will be measured up to 3 weeks for the outcome 1
2

Brain Imaging Outcomes - Cue Craving Scans

Functional magnetic resonance imaging (fMRI) scans of all Veterans to look at brain function connectivity. The investigators will compare the changes of brain activity between two treatment conditions.

Time frame
3-weeks

Secondary outcomes

1

7-day continuous quit rate (CQR)

Abstinence during a consecutive 7-day period in the treatment stage

Time frame
10 weeks
2

Likert Visual Analog Cue Craving Scale

Assess changes in subjective craving with each session. The visual analog cue craving scale from 0 to 7. 0 = minimum, 7 = maximum. A higher score means more craving (worse).

Time frame
10 weeks
3

Fagerstrom Test for Nicotine Dependence (FTND)

Standardized tool to assess intensity of physical addiction to nicotine.

Time frame
10 weeks
4

Minnesota Nicotine Withdrawal Scale-Revised

Self-report scale developed to evaluate the severity of nicotine withdrawal symptoms. self-report scale developed to evaluate the severity of nicotine withdrawal symptoms. It includes 15 items. Each item is from 0 to 4, total score, 0 = minimum, 60 = maximum. A higher score means worse.

Time frame
10 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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