CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 104 enrolled
Drug / intervention
Active intermittent theta burst stimulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05271175
NCT05271175N/ACompleted

Accelerated Intermittent Theta Burst Stimulation in Smoking Cessation: A Randomized Controlled Study

Cyprus rTMS Center·interventional·Posted Mar 8, 2022·Updated Sep 26, 2022

In Brief

A clinical study evaluating Active intermittent theta burst stimulation and Sham intermittent theta burst stimulation for Nicotine Dependence and Smoking Cessation. Completed, enrolled 104 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCyprus
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 8, 2022
Enrollment StartApr 19, 2019
Primary CompletionSep 7, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.3 years ago

Interventions

Active intermittent theta burst stimulationdevice

An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.

Sham intermittent theta burst stimulationdevice

An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.