Nicotine Dependence, Smoking Cessation
Conditions
Brief 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.
Detailed description
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. Behavioral and psychological interventions, pharmacological interventions as well as nicotine replacement therapy are some of the most used interventions for smoking cessation with medium to low success rates. Nonetheless, in recent years there has been growing interest in new, alternative, and effective treatments for smoking cessation. Transcranial magnetic stimulation (TMS) is a novel, powerful, non-invasive brain stimulation therapy. TMS non-invasively (transcranially) delivers magnetic pulses to a brain region, inducing electric a current that can depolarize neurons and induce action potentials. 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. The investigators hypothesized that twenty sessions of accelerated theta burst simulation over the left DLPFC while exposed to smoking-related cues, would reduce cigarette consumption and cigarette cravings, accompanied by reduced stress and motivation to quit smoking, compared to both active and sham stimulation with neutral-cues. A total of 104 cigarettes smokers, who wanted to quit smoking, were enrolled and were randomly divided into the three experimental groups: the first group received active aiTBS stimulation while watching neutral videos, the second group received active aiTBS stimulation while watching smoking-related videos and the last group received sham stimulation while watching smoking-related videos. Primary and secondary measurements were performed at the baseline, during the treatment period, at one week, one month and six months post rTMS treatment.
Interventions
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.
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.
Sponsors
Cyprus rTMS Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. aged 18-70 2. native or fluent Greek speaker.
Exclusion criteria
1. mental objects or implants in the brain, skull or near head (e.g., pacemakers, metal plates) 2. past or current of diagnosis of neurological or psychiatric disorder 3. use of psychiatric medication 4. past or current drug or alcohol abuse, other than nicotine 5. use of IQOS (I Quit Original Smoking) or electronic cigarettes (e-cigarettes).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carbon Monoxide (CO)- Evaluated Nicotine Consumption | Baseline | CO level was measured using the piCO Smokerlyzer breath carbon monoxide meter device prior to the first rTMS session. |
| Momentary Craving | Baseline | The Visual Analogue Scale (VAS) is a psychometric measurement instrument that measures symptom severity on a continuous scale. The VAS can be quickly and repeatedly administered between tasks and it has been used extensively in smoking research with TMS. We used the VAS to assess smoking craving by asking participants to respond to the question How much do you want to smoke right now?, on a scale from 0 no craving to 100 most craving ever experienced by choosing a response on a visual scale given in front of them on a tablet. |
| General Craving | Baseline | Tobacco Craving Questionnaire-Short Form (TCQ-SF) is a self-report measure that assesses tobacco craving in four dimensions. Each factor scale contains three items. TCQ-SF items were rated on a Likert scale of 1 (strongly disagree) to 7 (strongly agree). Total scores vary from 12 to 84, by summing the 12 items and the scores for each factor scale vary from 3 to 21 by summing the three items in each factor scale. A high score indicates high tobacco craving. |
| Self-reported Nicotine Consumption | Baseline | Τhe number of cigarettes participants usually smoke before the treatment. |
| Nicotine Dependence | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motivation to Quit Smoking | Baseline | Participants were asked to estimate how motivated they were to quit smoking from 0% to 100%. Τhe possible answers were: 0%, 25%, 50%, 75% and 100%. Higher values reflect greater motivation to quit smoking. |
| Perceived Stress | Baseline | Perceived Stress Scale-4 (PSS-4) is a self-report measure that is used to assess psychological stress. PSS-4 items were rated on a Likert scale, ranging from 0 to 4, with those on the positive subscale scored in reverse and the total score was calculated as a sum of these items. The scores vary from 0-16, with a higher score indicating higher perceived stress. |
Countries
Cyprus
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active TMS & Neutral Videos Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: 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. | 29 |
| Active TMS & Smoking Videos Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: 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. | 30 |
| Sham TMS & Smoking Videos Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: 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. | 30 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| One Month Follow up | Lost to Follow-up | 12 | 7 | 9 |
| One Week Follow up | Lost to Follow-up | 10 | 7 | 5 |
| Six Months Follow up | Lost to Follow-up | 8 | 2 | 2 |
Baseline characteristics
| Characteristic | Active TMS & Smoking Videos | Active TMS & Neutral Videos | Sham TMS & Smoking Videos | Total |
|---|---|---|---|---|
| Age, Continuous | 42.93 years STANDARD_DEVIATION 14.42 | 46.52 years STANDARD_DEVIATION 13.05 | 47.43 years STANDARD_DEVIATION 12.72 | 45.62 years STANDARD_DEVIATION 13.42 |
| Cigarettes per day | 26.83 cigarettes/day STANDARD_DEVIATION 12.86 | 27.55 cigarettes/day STANDARD_DEVIATION 15.37 | 30.00 cigarettes/day STANDARD_DEVIATION 13.38 | 28.13 cigarettes/day STANDARD_DEVIATION 13.8 |
| Education | 14.43 years STANDARD_DEVIATION 3.77 | 14.07 years STANDARD_DEVIATION 3.95 | 13.60 years STANDARD_DEVIATION 3.27 | 14.03 years STANDARD_DEVIATION 3.65 |
| How many times quitted | 1.00 quit attempts STANDARD_DEVIATION 1.11 | 0.90 quit attempts STANDARD_DEVIATION 0.77 | 1.20 quit attempts STANDARD_DEVIATION 1.56 | 1.03 quit attempts STANDARD_DEVIATION 1.19 |
| If ever quitted No | 10 Participants | 9 Participants | 11 Participants | 30 Participants |
| If ever quitted Yes | 20 Participants | 20 Participants | 19 Participants | 59 Participants |
| Occupation Private employee | 19 Participants | 13 Participants | 22 Participants | 54 Participants |
| Occupation Public employee | 4 Participants | 7 Participants | 1 Participants | 12 Participants |
| Occupation Retired | 4 Participants | 2 Participants | 3 Participants | 9 Participants |
| Occupation Self-employed / freelancer | 1 Participants | 5 Participants | 4 Participants | 10 Participants |
| Occupation Student | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Occupation Unemployed | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 12 Participants | 29 Participants |
| Sex: Female, Male Male | 20 Participants | 22 Participants | 18 Participants | 60 Participants |
| Types of cigarettes Cigarillos | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Types of cigarettes Hand-rolled | 5 Participants | 10 Participants | 5 Participants | 20 Participants |
| Types of cigarettes Mixed | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Types of cigarettes Normal | 25 Participants | 16 Participants | 24 Participants | 65 Participants |
| Years of smoking | 23.13 years STANDARD_DEVIATION 13.58 | 23.18 years STANDARD_DEVIATION 9.82 | 28.73 years STANDARD_DEVIATION 12.21 | 25.06 years STANDARD_DEVIATION 12.17 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 11 / 29 | 5 / 30 | 7 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
The average of the four CO-levels, measured before each of the four sessions on Day 1.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 19.09 ppm | Standard Error 12.14 |
| Active TMS & Smoking Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 14.83 ppm | Standard Error 8.47 |
| Sham TMS & Smoking Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 17.77 ppm | Standard Error 7.88 |
Primary
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
CO level was measured using the piCO Smokerlyzer breath carbon monoxide meter device prior to the first rTMS session.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 23.64 ppm | Standard Deviation 14.68 |
| Active TMS & Smoking Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 17.24 ppm | Standard Deviation 10.17 |
| Sham TMS & Smoking Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 21.13 ppm | Standard Deviation 9.63 |
Primary
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
The average of the four CO-levels, measured before each of the four sessions on Day 5.
Time frame: Day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 8.98 ppm | Standard Deviation 9.68 |
| Active TMS & Smoking Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 8.03 ppm | Standard Deviation 7.27 |
| Sham TMS & Smoking Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 8.18 ppm | Standard Deviation 7.02 |
Primary
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
The average of the four CO-levels, measured before each of the four sessions on Day 4.
Time frame: Day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 8.35 ppm | Standard Deviation 8.44 |
| Active TMS & Smoking Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 8.58 ppm | Standard Deviation 6.65 |
| Sham TMS & Smoking Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 8.89 ppm | Standard Deviation 6.96 |
Primary
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
The average of the four CO-levels, measured before each of the four sessions on Day 3.
Time frame: Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 9.98 ppm | Standard Deviation 10.15 |
| Active TMS & Smoking Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 9.61 ppm | Standard Deviation 6.63 |
| Sham TMS & Smoking Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 8.85 ppm | Standard Deviation 6.58 |
Primary
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
The average of the four CO-levels, measured before each of the four sessions on Day 2.
Time frame: Day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 11.09 ppm | Standard Deviation 9.69 |
| Active TMS & Smoking Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 9.94 ppm | Standard Deviation 8.17 |
| Sham TMS & Smoking Videos | Carbon Monoxide (CO)- Evaluated Nicotine Consumption | 11.03 ppm | Standard Deviation 7.5 |
Primary
General Craving
Tobacco Craving Questionnaire-Short Form (TCQ-SF) is a self-report measure that assesses tobacco craving in four dimensions. Each factor scale contains three items. TCQ-SF items were rated on a Likert scale of 1 (strongly disagree) to 7 (strongly agree). Total scores vary from 12 to 84, by summing the 12 items and the scores for each factor scale vary from 3 to 21 by summing the three items in each factor scale. A high score indicates high tobacco craving.
Time frame: 1 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | General Craving | 37.06 Total score | Standard Deviation 17.94 |
| Active TMS & Smoking Videos | General Craving | 30.61 Total score | Standard Deviation 19.63 |
| Sham TMS & Smoking Videos | General Craving | 35.24 Total score | Standard Deviation 20.63 |
Primary
General Craving
Tobacco Craving Questionnaire-Short Form (TCQ-SF) is a self-report measure that assesses tobacco craving in four dimensions. Each factor scale contains three items. TCQ-SF items were rated on a Likert scale of 1 (strongly disagree) to 7 (strongly agree). Total scores vary from 12 to 84, by summing the 12 items and the scores for each factor scale vary from 3 to 21 by summing the three items in each factor scale. A high score indicates high tobacco craving.
Time frame: 6 months follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | General Craving | 51.52 Total score | Standard Deviation 19.5 |
| Active TMS & Smoking Videos | General Craving | 38.32 Total score | Standard Deviation 18.22 |
| Sham TMS & Smoking Videos | General Craving | 44.68 Total score | Standard Deviation 22.34 |
Primary
General Craving
Tobacco Craving Questionnaire-Short Form (TCQ-SF) is a self-report measure that assesses tobacco craving in four dimensions. Each factor scale contains three items. TCQ-SF items were rated on a Likert scale of 1 (strongly disagree) to 7 (strongly agree). Total scores vary from 12 to 84, by summing the 12 items and the scores for each factor scale vary from 3 to 21 by summing the three items in each factor scale. A high score indicates high tobacco craving.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | General Craving | 45.38 Total score | Standard Deviation 17.95 |
| Active TMS & Smoking Videos | General Craving | 52.03 Total score | Standard Deviation 16.2 |
| Sham TMS & Smoking Videos | General Craving | 43.83 Total score | Standard Deviation 17.25 |
Primary
General Craving
Tobacco Craving Questionnaire-Short Form (TCQ-SF) is a self-report measure that assesses tobacco craving in four dimensions. Each factor scale contains three items. TCQ-SF items were rated on a Likert scale of 1 (strongly disagree) to 7 (strongly agree). Total scores vary from 12 to 84, by summing the 12 items and the scores for each factor scale vary from 3 to 21 by summing the three items in each factor scale. A high score indicates high tobacco craving.
Time frame: End of the treatment (On the fifth day, after completing 20 TMS sessions)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | General Craving | 30.93 Total score | Standard Deviation 17.05 |
| Active TMS & Smoking Videos | General Craving | 31.97 Total score | Standard Deviation 14.61 |
| Sham TMS & Smoking Videos | General Craving | 28.63 Total score | Standard Deviation 13.1 |
Primary
General Craving
Tobacco Craving Questionnaire-Short Form (TCQ-SF) is a self-report measure that assesses tobacco craving in four dimensions. Each factor scale contains three items. TCQ-SF items were rated on a Likert scale of 1 (strongly disagree) to 7 (strongly agree). Total scores vary from 12 to 84, by summing the 12 items and the scores for each factor scale vary from 3 to 21 by summing the three items in each factor scale. A high score indicates high tobacco craving.
Time frame: 1 week follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | General Craving | 29.84 Total score | Standard Deviation 14.18 |
| Active TMS & Smoking Videos | General Craving | 32.17 Total score | Standard Deviation 21.57 |
| Sham TMS & Smoking Videos | General Craving | 27.28 Total score | Standard Deviation 14.82 |
Primary
Momentary Craving
The Visual Analogue Scale (VAS) is a psychometric measurement instrument that measures symptom severity on a continuous scale. The VAS can be quickly and repeatedly administered between tasks and it has been used extensively in smoking research with TMS. We used the VAS to assess smoking craving by asking participants to respond to the question How much do you want to smoke right now?, on a scale from 0 no craving to 100 most craving ever experienced by choosing a response on a visual scale given in front of them on a tablet. The average of the eight VAS scores, measured prior and post each of the four sessions on Day 4.
Time frame: Day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Momentary Craving | 9.16 score on a scale | Standard Deviation 13.12 |
| Active TMS & Smoking Videos | Momentary Craving | 20.14 score on a scale | Standard Deviation 18.41 |
| Sham TMS & Smoking Videos | Momentary Craving | 14.44 score on a scale | Standard Deviation 19.18 |
Primary
Momentary Craving
The Visual Analogue Scale (VAS) is a psychometric measurement instrument that measures symptom severity on a continuous scale. The VAS can be quickly and repeatedly administered between tasks and it has been used extensively in smoking research with TMS. We used the VAS to assess smoking craving by asking participants to respond to the question How much do you want to smoke right now?, on a scale from 0 no craving to 100 most craving ever experienced by choosing a response on a visual scale given in front of them on a tablet. The average of the eight VAS scores, measured prior and post each of the four sessions on Day 5.
Time frame: Day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Momentary Craving | 10.57 score on a scale | Standard Deviation 15.74 |
| Active TMS & Smoking Videos | Momentary Craving | 16.08 score on a scale | Standard Deviation 16.14 |
| Sham TMS & Smoking Videos | Momentary Craving | 10.46 score on a scale | Standard Deviation 13.13 |
Primary
Momentary Craving
The Visual Analogue Scale (VAS) is a psychometric measurement instrument that measures symptom severity on a continuous scale. The VAS can be quickly and repeatedly administered between tasks and it has been used extensively in smoking research with TMS. We used the VAS to assess smoking craving by asking participants to respond to the question How much do you want to smoke right now?, on a scale from 0 no craving to 100 most craving ever experienced by choosing a response on a visual scale given in front of them on a tablet.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Momentary Craving | 24.21 score on a scale | Standard Deviation 30.64 |
| Active TMS & Smoking Videos | Momentary Craving | 30.87 score on a scale | Standard Deviation 28.63 |
| Sham TMS & Smoking Videos | Momentary Craving | 25.70 score on a scale | Standard Deviation 30.42 |
Primary
Momentary Craving
The Visual Analogue Scale (VAS) is a psychometric measurement instrument that measures symptom severity on a continuous scale. The VAS can be quickly and repeatedly administered between tasks and it has been used extensively in smoking research with TMS. We used the VAS to assess smoking craving by asking participants to respond to the question How much do you want to smoke right now?, on a scale from 0 no craving to 100 most craving ever experienced by choosing a response on a visual scale given in front of them on a tablet. The average of the eight VAS scores, measured prior and post each of the four sessions on Day 1.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Momentary Craving | 24.55 score on a scale | Standard Deviation 20.66 |
| Active TMS & Smoking Videos | Momentary Craving | 33.13 score on a scale | Standard Deviation 22.12 |
| Sham TMS & Smoking Videos | Momentary Craving | 29.03 score on a scale | Standard Deviation 28.59 |
Primary
Momentary Craving
The Visual Analogue Scale (VAS) is a psychometric measurement instrument that measures symptom severity on a continuous scale. The VAS can be quickly and repeatedly administered between tasks and it has been used extensively in smoking research with TMS. We used the VAS to assess smoking craving by asking participants to respond to the question How much do you want to smoke right now?, on a scale from 0 no craving to 100 most craving ever experienced by choosing a response on a visual scale given in front of them on a tablet. The average of the eight VAS scores, measured prior and post each of the four sessions on Day 2.
Time frame: Day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Momentary Craving | 15.62 score on a scale | Standard Deviation 16.69 |
| Active TMS & Smoking Videos | Momentary Craving | 23.54 score on a scale | Standard Deviation 18.88 |
| Sham TMS & Smoking Videos | Momentary Craving | 21.87 score on a scale | Standard Deviation 24.12 |
Primary
Momentary Craving
The Visual Analogue Scale (VAS) is a psychometric measurement instrument that measures symptom severity on a continuous scale. The VAS can be quickly and repeatedly administered between tasks and it has been used extensively in smoking research with TMS. We used the VAS to assess smoking craving by asking participants to respond to the question How much do you want to smoke right now?, on a scale from 0 no craving to 100 most craving ever experienced by choosing a response on a visual scale given in front of them on a tablet. The average of the eight VAS scores, measured prior and post each of the four sessions on Day 3.
Time frame: Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Momentary Craving | 12.45 score on a scale | Standard Deviation 15.33 |
| Active TMS & Smoking Videos | Momentary Craving | 22.32 score on a scale | Standard Deviation 19.87 |
| Sham TMS & Smoking Videos | Momentary Craving | 17.48 score on a scale | Standard Deviation 21.78 |
Primary
Nicotine Dependence
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.
Time frame: 1 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Nicotine Dependence | 3.35 score on a scale | Standard Deviation 1.97 |
| Active TMS & Smoking Videos | Nicotine Dependence | 2.78 score on a scale | Standard Deviation 2.8 |
| Sham TMS & Smoking Videos | Nicotine Dependence | 3.38 score on a scale | Standard Deviation 2.84 |
Primary
Nicotine Dependence
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.
Time frame: 6 months follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Nicotine Dependence | 3.71 score on a scale | Standard Deviation 2.43 |
| Active TMS & Smoking Videos | Nicotine Dependence | 3.32 score on a scale | Standard Deviation 2.74 |
| Sham TMS & Smoking Videos | Nicotine Dependence | 3.96 score on a scale | Standard Deviation 2.57 |
Primary
Nicotine Dependence
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Nicotine Dependence | 5.86 score on a scale | Standard Deviation 2.26 |
| Active TMS & Smoking Videos | Nicotine Dependence | 6.03 score on a scale | Standard Deviation 2.37 |
| Sham TMS & Smoking Videos | Nicotine Dependence | 6.77 score on a scale | Standard Deviation 2.27 |
Primary
Nicotine Dependence
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.
Time frame: End of the treatment (On the fifth day, after completing 20 TMS sessions)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Nicotine Dependence | 2.31 score on a scale | Standard Deviation 2.62 |
| Active TMS & Smoking Videos | Nicotine Dependence | 2.03 score on a scale | Standard Deviation 2.08 |
| Sham TMS & Smoking Videos | Nicotine Dependence | 2.57 score on a scale | Standard Deviation 2.69 |
Primary
Nicotine Dependence
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.
Time frame: 1 week follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Nicotine Dependence | 1.79 score on a scale | Standard Deviation 1.55 |
| Active TMS & Smoking Videos | Nicotine Dependence | 2.04 score on a scale | Standard Deviation 2.49 |
| Sham TMS & Smoking Videos | Nicotine Dependence | 2.64 score on a scale | Standard Deviation 2.41 |
Primary
Self-reported Nicotine Consumption
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
Time frame: After 2nd treatment day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Self-reported Nicotine Consumption | 7.94 cigarettes/day | Standard Deviation 8.13 |
| Active TMS & Smoking Videos | Self-reported Nicotine Consumption | 7.07 cigarettes/day | Standard Deviation 6.43 |
| Sham TMS & Smoking Videos | Self-reported Nicotine Consumption | 9.38 cigarettes/day | Standard Deviation 7.9 |
Primary
Self-reported Nicotine Consumption
Τhe number of cigarettes participants usually smoke before the treatment.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Self-reported Nicotine Consumption | 27.55 cigarettes/day | Standard Error 15.37 |
| Active TMS & Smoking Videos | Self-reported Nicotine Consumption | 26.83 cigarettes/day | Standard Error 12.86 |
| Sham TMS & Smoking Videos | Self-reported Nicotine Consumption | 30.00 cigarettes/day | Standard Error 13.38 |
Primary
Self-reported Nicotine Consumption
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
Time frame: After 4th treatment day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Self-reported Nicotine Consumption | 5.27 cigarettes/day | Standard Deviation 7.51 |
| Active TMS & Smoking Videos | Self-reported Nicotine Consumption | 4.67 cigarettes/day | Standard Deviation 6.5 |
| Sham TMS & Smoking Videos | Self-reported Nicotine Consumption | 6.27 cigarettes/day | Standard Deviation 7.84 |
Primary
Self-reported Nicotine Consumption
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
Time frame: After 3rd treatment day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Self-reported Nicotine Consumption | 5.92 cigarettes/day | Standard Deviation 6.68 |
| Active TMS & Smoking Videos | Self-reported Nicotine Consumption | 7.79 cigarettes/day | Standard Deviation 8.61 |
| Sham TMS & Smoking Videos | Self-reported Nicotine Consumption | 8.20 cigarettes/day | Standard Deviation 7.8 |
Primary
Self-reported Nicotine Consumption
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
Time frame: After 1st treatment day
Population: Two participants from the Active TMS \& Neutral videos group and three participants from the Active TMS \& Smoking videos group were outliers and were therefore excluded from the analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Self-reported Nicotine Consumption | 8.72 cigarettes/day | Standard Deviation 8.97 |
| Active TMS & Smoking Videos | Self-reported Nicotine Consumption | 8.67 cigarettes/day | Standard Deviation 8.56 |
| Sham TMS & Smoking Videos | Self-reported Nicotine Consumption | 10.60 cigarettes/day | Standard Deviation 7.49 |
Secondary
Motivation to Quit Smoking
Participants were asked to estimate how motivated they were to quit smoking from 0% to 100%. Τhe possible answers were: 0%, 25%, 50%, 75% and 100%. Higher values reflect greater motivation to quit smoking.
Time frame: 6 months follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Motivation to Quit Smoking | 41.67 score on a scale | Standard Deviation 34.76 |
| Active TMS & Smoking Videos | Motivation to Quit Smoking | 67.86 score on a scale | Standard Deviation 32.53 |
| Sham TMS & Smoking Videos | Motivation to Quit Smoking | 52.68 score on a scale | Standard Deviation 34.92 |
Secondary
Motivation to Quit Smoking
Participants were asked to estimate how motivated they were to quit smoking from 0% to 100%. Τhe possible answers were: 0%, 25%, 50%, 75% and 100%. Higher values reflect greater motivation to quit smoking.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Motivation to Quit Smoking | 77.78 score on a scale | Standard Deviation 21.18 |
| Active TMS & Smoking Videos | Motivation to Quit Smoking | 82.41 score on a scale | Standard Deviation 18.1 |
| Sham TMS & Smoking Videos | Motivation to Quit Smoking | 80.83 score on a scale | Standard Deviation 20.43 |
Secondary
Motivation to Quit Smoking
Participants were asked to estimate how motivated they were to quit smoking from 0% to 100%. Τhe possible answers were: 0%, 25%, 50%, 75% and 100%. Higher values reflect greater motivation to quit smoking.
Time frame: End of the treatment (On the fifth day, after completing 20 TMS sessions)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Motivation to Quit Smoking | 82.41 score on a scale | Standard Deviation 20.59 |
| Active TMS & Smoking Videos | Motivation to Quit Smoking | 84.26 score on a scale | Standard Deviation 19.79 |
| Sham TMS & Smoking Videos | Motivation to Quit Smoking | 80.83 score on a scale | Standard Deviation 23.38 |
Secondary
Motivation to Quit Smoking
Participants were asked to estimate how motivated they were to quit smoking from 0% to 100%. Τhe possible answers were: 0%, 25%, 50%, 75% and 100%. Higher values reflect greater motivation to quit smoking.
Time frame: 1 week follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Motivation to Quit Smoking | 72.37 score on a scale | Standard Deviation 23.41 |
| Active TMS & Smoking Videos | Motivation to Quit Smoking | 77.17 score on a scale | Standard Deviation 30.07 |
| Sham TMS & Smoking Videos | Motivation to Quit Smoking | 75.00 score on a scale | Standard Deviation 27.95 |
Secondary
Motivation to Quit Smoking
Participants were asked to estimate how motivated they were to quit smoking from 0% to 100%. Τhe possible answers were: 0%, 25%, 50%, 75% and 100%. Higher values reflect greater motivation to quit smoking.
Time frame: 1 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Motivation to Quit Smoking | 47.06 score on a scale | Standard Deviation 31.72 |
| Active TMS & Smoking Videos | Motivation to Quit Smoking | 70.65 score on a scale | Standard Deviation 37.43 |
| Sham TMS & Smoking Videos | Motivation to Quit Smoking | 52.38 score on a scale | Standard Deviation 38.65 |
Secondary
Perceived Stress
Perceived Stress Scale-4 (PSS-4) is a self-report measure that is used to assess psychological stress. PSS-4 items were rated on a Likert scale, ranging from 0 to 4, with those on the positive subscale scored in reverse and the total score was calculated as a sum of these items. The scores vary from 0-16, with a higher score indicating higher perceived stress.
Time frame: 1 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Perceived Stress | 4.06 score on a scale | Standard Deviation 2.66 |
| Active TMS & Smoking Videos | Perceived Stress | 5.57 score on a scale | Standard Deviation 2.13 |
| Sham TMS & Smoking Videos | Perceived Stress | 3.52 score on a scale | Standard Deviation 2.48 |
Secondary
Perceived Stress
Perceived Stress Scale-4 (PSS-4) is a self-report measure that is used to assess psychological stress. PSS-4 items were rated on a Likert scale, ranging from 0 to 4, with those on the positive subscale scored in reverse and the total score was calculated as a sum of these items. The scores vary from 0-16, with a higher score indicating higher perceived stress.
Time frame: 1 week follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Perceived Stress | 4.42 score on a scale | Standard Deviation 2.59 |
| Active TMS & Smoking Videos | Perceived Stress | 6.00 score on a scale | Standard Deviation 2.66 |
| Sham TMS & Smoking Videos | Perceived Stress | 4.76 score on a scale | Standard Deviation 2.35 |
Secondary
Perceived Stress
Perceived Stress Scale-4 (PSS-4) is a self-report measure that is used to assess psychological stress. PSS-4 items were rated on a Likert scale, ranging from 0 to 4, with those on the positive subscale scored in reverse and the total score was calculated as a sum of these items. The scores vary from 0-16, with a higher score indicating higher perceived stress.
Time frame: 6 months follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Perceived Stress | 4.67 score on a scale | Standard Deviation 1.88 |
| Active TMS & Smoking Videos | Perceived Stress | 5.75 score on a scale | Standard Deviation 2.05 |
| Sham TMS & Smoking Videos | Perceived Stress | 4.75 score on a scale | Standard Deviation 2.52 |
Secondary
Perceived Stress
Perceived Stress Scale-4 (PSS-4) is a self-report measure that is used to assess psychological stress. PSS-4 items were rated on a Likert scale, ranging from 0 to 4, with those on the positive subscale scored in reverse and the total score was calculated as a sum of these items. The scores vary from 0-16, with a higher score indicating higher perceived stress.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Perceived Stress | 5.97 score on a scale | Standard Deviation 2.18 |
| Active TMS & Smoking Videos | Perceived Stress | 6.53 score on a scale | Standard Deviation 2.4 |
| Sham TMS & Smoking Videos | Perceived Stress | 5.60 score on a scale | Standard Deviation 1.98 |
Secondary
Perceived Stress
Perceived Stress Scale-4 (PSS-4) is a self-report measure that is used to assess psychological stress. PSS-4 items were rated on a Likert scale, ranging from 0 to 4, with those on the positive subscale scored in reverse and the total score was calculated as a sum of these items. The scores vary from 0-16, with a higher score indicating higher perceived stress.
Time frame: End of the treatment (On the fifth day, after completing 20 TMS sessions)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TMS & Neutral Videos | Perceived Stress | 5.21 score on a scale | Standard Deviation 2.47 |
| Active TMS & Smoking Videos | Perceived Stress | 5.90 score on a scale | Standard Deviation 2.34 |
| Sham TMS & Smoking Videos | Perceived Stress | 4.60 score on a scale | Standard Deviation 1.96 |