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Accelerated iTBS in Smoking Cessation
NA trial testing Active intermittent theta burst stimulation in Nicotine Dependence in 104 participants. Completed in 7 September 2020.
| Lead sponsor | Cyprus rTMS Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 104 |
| Start date | 19 April 2019 |
| Primary completion | 7 September 2020 |
| Estimated completion | 7 September 2020 |
| Sites | 1 location across Cyprus |
Cyprus rTMS Center
Adults 18 to 70, any sex, with Nicotine Dependence or Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Τhe number of cigarettes participants usually smoke before the treatment.
| Group | Value | 95% CI |
|---|---|---|
| Active TMS & Neutral Videos | 27.55 | ± 15.37 |
| Active TMS & Smoking Videos | 26.83 | ± 12.86 |
| Sham TMS & Smoking Videos | 30.00 | ± 13.38 |
Participants were required to record the number of cigarettes smoked after the completion of the 1st day of treatment until before the first session on the second day of treatment. Participants were asked not to smoke during the breaks of the 4 daily rTMS sessions
| Group | Value | 95% CI |
|---|---|---|
| Active TMS & Neutral Videos | 8.72 | ± 8.97 |
| Active TMS & Smoking Videos | 8.67 | ± 8.56 |
| Sham TMS & Smoking Videos | 10.60 | ± 7.49 |
Participants were required to record the number of cigarettes smoked after the completion of the 2nd day of treatment until before the first session on the 3rd day of treatment. Participants were asked not to smoke during the breaks of the 4 daily rTMS sessions
| Group | Value | 95% CI |
|---|---|---|
| Active TMS & Neutral Videos | 7.94 | ± 8.13 |
| Active TMS & Smoking Videos | 7.07 | ± 6.43 |
| Sham TMS & Smoking Videos | 9.38 | ± 7.90 |
Participants were required to record the number of cigarettes smoked after the completion of the 3rd day of treatment until before the first session on the 4th day of treatment. Participants were asked not to smoke during the breaks of the 4 daily rTMS sessions
| Group | Value | 95% CI |
|---|---|---|
| Active TMS & Neutral Videos | 5.92 | ± 6.68 |
| Active TMS & Smoking Videos | 7.79 | ± 8.61 |
| Sham TMS & Smoking Videos | 8.20 | ± 7.80 |
Participants were required to record the number of cigarettes smoked after the completion of the 4th day of treatment until before the first session on the 5th day of treatment . Participants were asked not to smoke during the breaks of the 4 daily rTMS sessions
| Group | Value | 95% CI |
|---|---|---|
| Active TMS & Neutral Videos | 5.27 | ± 7.51 |
| Active TMS & Smoking Videos | 4.67 | ± 6.50 |
| Sham TMS & Smoking Videos | 6.27 | ± 7.84 |
CO level was measured using the piCO Smokerlyzer breath carbon monoxide meter device prior to the first rTMS session.
| Group | Value | 95% CI |
|---|---|---|
| Active TMS & Neutral Videos | 23.64 | ± 14.68 |
| Active TMS & Smoking Videos | 17.24 | ± 10.17 |
| Sham TMS & Smoking Videos | 21.13 | ± 9.63 |
The average of the four CO-levels, measured before each of the four sessions on Day 1.
| Group | Value | 95% CI |
|---|---|---|
| Active TMS & Neutral Videos | 19.09 | ± 12.14 |
| Active TMS & Smoking Videos | 14.83 | ± 8.47 |
| Sham TMS & Smoking Videos | 17.77 | ± 7.88 |
The average of the four CO-levels, measured before each of the four sessions on Day 2.
| Group | Value | 95% CI |
|---|---|---|
| Active TMS & Neutral Videos | 11.09 | ± 9.69 |
| Active TMS & Smoking Videos | 9.94 | ± 8.17 |
| Sham TMS & Smoking Videos | 11.03 | ± 7.50 |
The average of the four CO-levels, measured before each of the four sessions on Day 3.
| Group | Value | 95% CI |
|---|---|---|
| Active TMS & Neutral Videos | 9.98 | ± 10.15 |
| Active TMS & Smoking Videos | 9.61 | ± 6.63 |
| Sham TMS & Smoking Videos | 8.85 | ± 6.58 |
The average of the four CO-levels, measured before each of the four sessions on Day 4.
| Group | Value | 95% CI |
|---|---|---|
| Active TMS & Neutral Videos | 8.35 | ± 8.44 |
| Active TMS & Smoking Videos | 8.58 | ± 6.65 |
| Sham TMS & Smoking Videos | 8.89 | ± 6.96 |
The average of the four CO-levels, measured before each of the four sessions on Day 5.
| Group | Value | 95% CI |
|---|---|---|
| Active TMS & Neutral Videos | 8.98 | ± 9.68 |
| Active TMS & Smoking Videos | 8.03 | ± 7.27 |
| Sham TMS & Smoking Videos | 8.18 | ± 7.02 |
Fagerström test for Nicotine Dependence (FTND) is a short, self-report measure that assesses nicotine dependence. It contains six questions, and the total score is calculated as a sum of these six questions. The scores vary from 0 to 10, with lower scores indicating lower dependence on nicotine.
| Group | Value | 95% CI |
|---|---|---|
| Active TMS & Neutral Videos | 5.86 | ± 2.26 |
| Active TMS & Smoking Videos | 6.03 | ± 2.37 |
| Sham TMS & Smoking Videos | 6.77 | ± 2.27 |
Time frame: 1 week. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Active TMS & Neutral Videos | Active TMS & Smoking Videos | Sham TMS & Smoking Videos |
|---|---|---|---|---|
| Mild headache | General disorders | — | — | — |
| Sleepiness | General disorders | — | — | — |
| Insomnia | General disorders | — | — | — |
| Nausea | General disorders | — | — | — |
| Numbness on stimulation site | General disorders | — | — | — |
| Tension | General disorders | — | — | — |
| Lightheadedness | General disorders | — | — | — |
| Coghiness | General disorders | — | — | — |
| Numbness on stimulation site & Forgetfulness | General disorders | — | — | — |
| Numbness on stimulation site & Sleepiness | General disorders | — | — | — |
| Mild headache & Sleepiness | General disorders | — | — | — |
Data from ClinicalTrials.gov NCT05271175 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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