Nicotine DependenceNCT05271175
Accelerated iTBS in Smoking Cessation
A study testing Active intermittent theta burst stimulation in people with Nicotine Dependence and Smoking Cessation, run by Cyprus rTMS Center at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Smoking Cessation
- What is being tested?
- Active intermittent theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteCyprus
- Study dates
- 19 Apr 2019to 7 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18-70
- native or fluent Greek speaker.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accelerated Intermittent Theta Burst Stimulation in Smoking Cessation: A Randomized Controlled Study
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.
Read the 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.
- Conditions
- Nicotine Dependence, Smoking Cessation
- Being tested
- Active intermittent theta burst stimulation, Sham intermittent theta burst stimulation
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Active TMS & Neutral videos | Experimental | Received active iTBS stimulation while watching neutral videos Receives: Device: Active intermittent theta burst stimulation |
| Active TMS & Smoking videos | Experimental | Received active iTBS stimulation while watching smoking-related videos Receives: Device: Active intermittent theta burst stimulation |
| Sham TMS & Smoking videos | Sham comparator | Received sham stimulation while watching smoking-related videos Receives: Device: Sham intermittent theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Nicotine Consumption
Τhe number of cigarettes participants usually smoke before the treatment.
Measured: Baseline
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
Measured: After 1st treatment day
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
Measured: After 2nd treatment day
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
Measured: After 3rd treatment day
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
Measured: After 4th treatment day
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.
Measured: Baseline
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
The average of the four CO-levels, measured before each of the four sessions on Day 1.
Measured: Day 1
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
The average of the four CO-levels, measured before each of the four sessions on Day 2.
Measured: Day 2
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
The average of the four CO-levels, measured before each of the four sessions on Day 3.
Measured: Day 3
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
The average of the four CO-levels, measured before each of the four sessions on Day 4.
Measured: Day 4
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
The average of the four CO-levels, measured before each of the four sessions on Day 5.
Measured: Day 5
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.
Measured: Baseline
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.
Measured: End of the treatment (On the fifth day, after completing 20 TMS sessions)
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.
Measured: 1 week follow up
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.
Measured: 1 month follow up
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.
Measured: 6 months follow up
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.
Measured: Baseline
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.
Measured: Day 1
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.
Measured: Day 2
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.
Measured: Day 3
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.
Measured: Day 4
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.
Measured: Day 5
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.
Measured: Baseline
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.
Measured: End of the treatment (On the fifth day, after completing 20 TMS sessions)
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.
Measured: 1 week follow up
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.
Measured: 1 month follow up
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.
Measured: 6 months follow up
Secondary outcomes (10)
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.
Measured: Baseline
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.
Measured: End of the treatment (On the fifth day, after completing 20 TMS sessions)
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.
Measured: 1 week follow up
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.
Measured: 1 month follow up
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.
Measured: 6 months follow up
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.
Measured: Baseline
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.
Measured: End of the treatment (On the fifth day, after completing 20 TMS sessions)
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.
Measured: 1 week follow up
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.
Measured: 1 month follow up
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.
Measured: 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start19 Apr 2019
- Primary completion7 Sep 2020
- Study completion7 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyprus rTMS Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Sack, Principal investigator, Maastricht University, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271175
- Sponsor's protocol ID
- 08.2019CY
- Status last verified
- Sep 2022
- First submitted
- 4 Feb 2022
- Last updated
- 26 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mikellides G, Michael P, Psalta L, Stefani A, Schuhmann T, Sack AT. Accelerated Intermittent Theta Burst Stimulation in Smoking Cessation: Placebo Effects Equal to Active Stimulation When Using Advanced Placebo Coil Technology. Front Psychiatry. 2022 May 24;13:892075. doi: 10.3389/fpsyt.2022.892075. eCollection 2022.
PubMed 35686190
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Intermittent Theta Burst Stimulation in Smoking Cessation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05271175
- Acronym / sponsor ID
- 08.2019CY
- Conditions
- Nicotine Dependence, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Cyprus rTMS CenterUniversity, hospital or other
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 7 Sep 2020 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Posted 13 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active TMS & Neutral videos | Experimental | Device: Active intermittent theta burst stimulationReceived active iTBS stimulation while watching neutral videos |
| Active TMS & Smoking videos | Experimental | Device: Active intermittent theta burst stimulationReceived active iTBS stimulation while watching smoking-related videos |
| Sham TMS & Smoking videos | Sham comparator | Device: Sham intermittent theta burst stimulationReceived sham stimulation while watching smoking-related videos |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18-70
- native or fluent Greek speaker.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active intermittent theta burst stimulationAn 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. | Device | Active TMS & Neutral videos, Active TMS & Smoking videos |
| Sham intermittent theta burst stimulationAn 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. | Device | Sham TMS & Smoking videos |
Primary outcome
Self-reported Nicotine Consumption
Time frame: Baseline
Τhe number of cigarettes participants usually smoke before the treatment.
Self-reported Nicotine Consumption
Time frame: After 1st treatment day
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
Self-reported Nicotine Consumption
Time frame: After 2nd treatment day
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
Self-reported Nicotine Consumption
Time frame: After 3rd treatment day
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
Self-reported Nicotine Consumption
Time frame: After 4th treatment day
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
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
Time frame: Baseline
CO level was measured using the piCO Smokerlyzer breath carbon monoxide meter device prior to the first rTMS session.
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
Time frame: Day 1
The average of the four CO-levels, measured before each of the four sessions on Day 1.
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
Time frame: Day 2
The average of the four CO-levels, measured before each of the four sessions on Day 2.
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
Time frame: Day 3
The average of the four CO-levels, measured before each of the four sessions on Day 3.
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
Time frame: Day 4
The average of the four CO-levels, measured before each of the four sessions on Day 4.
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
Time frame: Day 5
The average of the four CO-levels, measured before each of the four sessions on Day 5.
Nicotine Dependence
Time frame: 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.
Nicotine Dependence
Time frame: End of the treatment (On the fifth day, after completing 20 TMS sessions)
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.
Nicotine Dependence
Time frame: 1 week follow up
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.
Nicotine Dependence
Time frame: 1 month follow up
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.
Nicotine Dependence
Time frame: 6 months follow up
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.
Momentary Craving
Time frame: 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.
Momentary Craving
Time frame: Day 1
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.
Momentary Craving
Time frame: Day 2
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.
Momentary Craving
Time frame: Day 3
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.
Momentary Craving
Time frame: Day 4
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.
Momentary Craving
Time frame: Day 5
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.
General Craving
Time frame: 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.
General Craving
Time frame: End of the treatment (On the fifth day, after completing 20 TMS sessions)
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.
General Craving
Time frame: 1 week follow up
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.
General Craving
Time frame: 1 month follow up
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.
General Craving
Time frame: 6 months follow up
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.
10 secondary outcomes
Perceived Stress
Time frame: Baseline
Perceived Stress
Time frame: End of the treatment (On the fifth day, after completing 20 TMS sessions)
Perceived Stress
Time frame: 1 week follow up
Perceived Stress
Time frame: 1 month follow up
Perceived Stress
Time frame: 6 months follow up
Motivation to Quit Smoking
Time frame: Baseline
Motivation to Quit Smoking
Time frame: End of the treatment (On the fifth day, after completing 20 TMS sessions)
Motivation to Quit Smoking
Time frame: 1 week follow up
Motivation to Quit Smoking
Time frame: 1 month follow up
Motivation to Quit Smoking
Time frame: 6 months follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35686190Mikellides G, Michael P, Psalta L, Stefani A, Schuhmann T, Sack AT. Accelerated Intermittent Theta Burst Stimulation in Smoking Cessation: Placebo Effects Equal to Active Stimulation When Using Advanced Placebo Coil Technology. Front Psychiatry. 2022 May 24;13:892075. doi: 10.3389/fpsyt.2022.892075. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Sack principal investigator
Maastricht University, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active intermittent theta burst stimulation in people with Nicotine Dependence and Smoking Cessation, run by Cyprus rTMS Center at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Nicotine Consumption (time frame: Baseline). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05271175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.