N/A N=104 Randomized Double-blind Treatment

Accelerated iTBS in Smoking Cessation

Nicotine Dependence · Smoking Cessation

Bottom Line

View on ClinicalTrials.gov: NCT05271175 ↗

Enrolled (actual)

104

Serious AEs

0.0%

Results posted

Sep 2022

Primary outcome: Primary: Self-reported Nicotine Consumption — 27.55; 26.83; 30.00 cigarettes/day

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Active intermittent theta burst stimulation (Device); Sham intermittent theta burst stimulation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cyprus rTMS Center
Primary completion: Sep 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Self-reported Nicotine Consumption	5.27; 4.67; 6.27	—
PRIMARY Self-reported Nicotine Consumption	5.27; 4.67; 6.27	—
PRIMARY Self-reported Nicotine Consumption	5.27; 4.67; 6.27	—
PRIMARY Self-reported Nicotine Consumption	5.27; 4.67; 6.27	—
PRIMARY Self-reported Nicotine Consumption	5.27; 4.67; 6.27	—
PRIMARY Carbon Monoxide (CO)- Evaluated Nicotine Consumption	8.98; 8.03; 8.18	—
PRIMARY Carbon Monoxide (CO)- Evaluated Nicotine Consumption	8.98; 8.03; 8.18	—
PRIMARY Carbon Monoxide (CO)- Evaluated Nicotine Consumption	8.98; 8.03; 8.18	—
PRIMARY Carbon Monoxide (CO)- Evaluated Nicotine Consumption	8.98; 8.03; 8.18	—
PRIMARY Carbon Monoxide (CO)- Evaluated Nicotine Consumption	8.98; 8.03; 8.18	—
PRIMARY Carbon Monoxide (CO)- Evaluated Nicotine Consumption	8.98; 8.03; 8.18	—
PRIMARY Nicotine Dependence	3.71; 3.32; 3.96	—
PRIMARY Nicotine Dependence	3.71; 3.32; 3.96	—
PRIMARY Nicotine Dependence	3.71; 3.32; 3.96	—
PRIMARY Nicotine Dependence	3.71; 3.32; 3.96	—
PRIMARY Nicotine Dependence	3.71; 3.32; 3.96	—
PRIMARY Momentary Craving	10.57; 16.08; 10.46	—
PRIMARY Momentary Craving	10.57; 16.08; 10.46	—
PRIMARY Momentary Craving	10.57; 16.08; 10.46	—
PRIMARY Momentary Craving	10.57; 16.08; 10.46	—
PRIMARY Momentary Craving	10.57; 16.08; 10.46	—
PRIMARY Momentary Craving	10.57; 16.08; 10.46	—
PRIMARY General Craving	51.52; 38.32; 44.68	—
PRIMARY General Craving	51.52; 38.32; 44.68	—
PRIMARY General Craving	51.52; 38.32; 44.68	—
PRIMARY General Craving	51.52; 38.32; 44.68	—
PRIMARY General Craving	51.52; 38.32; 44.68	—
SECONDARY Perceived Stress	4.67; 5.75; 4.75	—
SECONDARY Perceived Stress	4.67; 5.75; 4.75	—
SECONDARY Perceived Stress	4.67; 5.75; 4.75	—
SECONDARY Perceived Stress	4.67; 5.75; 4.75	—
SECONDARY Perceived Stress	4.67; 5.75; 4.75	—
SECONDARY Motivation to Quit Smoking	41.67; 67.86; 52.68	—
SECONDARY Motivation to Quit Smoking	41.67; 67.86; 52.68	—
SECONDARY Motivation to Quit Smoking	41.67; 67.86; 52.68	—
SECONDARY Motivation to Quit Smoking	41.67; 67.86; 52.68	—
SECONDARY Motivation to Quit Smoking	41.67; 67.86; 52.68	—

Summary

Cigarette smoking is one of the foremost causes of preventable disease and premature death. In 2014, 68% of adult smokers wanted to quit smoking and in 2017, 55.1% of adult smokers had made a quit attempt. However, only a small percentage of adult smokers (7,4%) achieved to quit smoking. Transcranial magnetic stimulation (TMS) is a novel, powerful, non-invasive brain stimulation therapy. This study used Theta Burst Stimulation (TBS), a newer form of rTMS protocol that can be delivered in a shorter duration compared to the standard rTMS protocol, while delivering a comparable number of pulses. It is a tolerable, powerful, and useful tool in non-invasive brain stimulation therapies. This double-blind randomized control trial evaluated the efficacy of 4 iTBS sessions per day during 5 consecutive days over the left DLPFC in smoking cessation. Moreover, it investigated whether the exposure to smoking-related cues during the rTMS treatment, compared to neutral cues impact cigarette craving.

Eligibility Criteria

Inclusion Criteria

aged 18-70
native or fluent Greek speaker.

Exclusion Criteria

mental objects or implants in the brain, skull or near head (e.g., pacemakers, metal plates)
past or current of diagnosis of neurological or psychiatric disorder
use of psychiatric medication
past or current drug or alcohol abuse, other than nicotine
use of IQOS ("I Quit Original Smoking") or electronic cigarettes (e-cigarettes).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05271175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.