Health TrialsbyHealthPanel

RTMS Targets Neural Circuits for Smoking Cessation

ConditionsTobacco UseCigarette Smoking
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorMedical University of South Carolina

About this trial

Cigarette smoking is a significant public health concern. Transcranial magnetic stimulation (TMS) is a non-invasive form of brain stimulation that has already displayed remarkable potential for producing novel, non-pharmacological interventions for depression and cigarette smokers. In this study, investigators will use brain MRI to guide TMS therapy for smoking cessation.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Be between the ages of 22 and 70 years old.

Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level > 10 ppm indicative of recent smoking.

Have not received substance abuse treatment within the previous 30 days.

Meet the criteria for tobacco use disorder as determined by DSM-5.

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., presence of metal in the skull, orbital or intracranial cavity, or having claustrophobia).

Contraindication to rTMS.

History of autoimmune, endocrine, viral, or vascular disorders affecting the brain.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sham rTMS

    Device

    Two electrodes on the scalp will be connected to transcutaneous electrical nerve stimulation.

  • Active rTMS 10 Hz DLPFC

    Device

    10 Hz repetitive transcranial magnetic stimulation (rTMS) will be delivered over left dorsolateral prefrontal cortex (DLPFC).

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Sham rTMSSham comparator 1 intervention
Group B: Active rTMS 10 Hz DLPFCActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

4 week continue quit rate

Measured by self-report of smoking abstinence in the past 4 weeks and confirmed using urine cotinine measurement.

Time frame
20 weeks
2

Task-functional connectivity from functional magnetic resonance imaging (fMRI)

The strength of functional connectivity is used to present the brain activities. The fMRI scans will be measured before the first TMS, after 2 weeks TMS and after the last TMS treatment.

Time frame
4 week
3

Cigarette per day

Cigarette per day (CPD) is measured to index smoking reduction and cigarette consumption.

Time frame
20 weeks
4

Adverse Event

Participants will be asked about adverse events (AE) each visit during treatment. AEs will be measured each TMS treatment visit.

Time frame
4 weeks

Secondary outcomes

1

Craving for cigarettes

Measured with a visual analog scale (VAS). The VAS has 1-7 score. The minimum is 1 which means the lowest craving for smoking. The maximum value is 7 which is the highest craving for cigarettes. Participants will be asked to complete the scale each treatment visit.

Time frame
4 weeks
2

Prolonged abstinence rate from end of treatment (Week 4) to end of follow-up (Week 20).

Measured by self-report of smoking abstinence and confirmed using urine cotinine measurement.

Time frame
20 weeks

Other outcomes

Sponsors and contacts

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

Medical University of South Carolina

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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