Accelerated iTBS in Smoking Cessation

NCT05271175 | Completed Results FDA Device

• 1 other identifier: 08.2019CY
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence; Smoking Cessation

Outcome Measures

Primary Outcomes (27)

• Self-reported Nicotine Consumption

  Τhe number of cigarettes participants usually smoke before the treatment.

  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

  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

  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

  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

  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.

  Baseline

• Carbon Monoxide (CO)- Evaluated Nicotine Consumption

  The average of the four CO-levels, measured before each of the four sessions on Day 1.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  6 months follow up

Secondary Outcomes (10)

• Perceived Stress

  Baseline

• Perceived Stress

  End of the treatment (On the fifth day, after completing 20 TMS sessions)

• Perceived Stress

  1 week follow up

• Perceived Stress

  1 month follow up

• Perceived Stress

  6 months follow up

Study Arms (3)

Active TMS & Neutral videos

EXPERIMENTAL

Received active iTBS stimulation while watching neutral videos

Device: Active intermittent theta burst stimulation

Active TMS & Smoking videos

EXPERIMENTAL

Received active iTBS stimulation while watching smoking-related videos

Device: Active intermittent theta burst stimulation

Sham TMS & Smoking videos

SHAM COMPARATOR

Received sham stimulation while watching smoking-related videos

Device: Sham intermittent theta burst stimulation

Interventions

Active intermittent theta burst stimulation DEVICE

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.

Active TMS & Neutral videos; Active TMS & Smoking videos

Sham intermittent theta burst stimulation DEVICE

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.

Sham TMS & Smoking videos

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-70
• native or fluent Greek speaker.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cyprus rTMS Center: lead

Study Sites (1)

Cyprus rTMS

Larnaca, Cyprus

Location

Related Publications (1)

• 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.

  PMID: 35686190 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Results Point of Contact

• Title: Georgios Mikellides
• Organization: Cyprus rTMS

george.mikellides@gmail.com

0035799430330

Study Officials

• Alexander Sack

  Maastricht University, The Netherlands

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 8, 2022
• Study Start: April 19, 2019
• Primary Completion: September 7, 2020
• Study Completion: September 7, 2020
• Last Updated: September 26, 2022
• Results First Posted: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)