Clinical trial NCT05271175: Accelerated iTBS in Smoking Cessation
Official title: Accelerated Intermittent Theta Burst Stimulation in Smoking Cessation: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Smoking Cessation
Lead sponsor: Cyprus rTMS Center
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Self-reported Nicotine Consumption
timeFrame: Baseline
measure: Self-reported Nicotine Consumption
timeFrame: After 1st treatment day
measure: Self-reported Nicotine Consumption
timeFrame: After 2nd treatment day
measure: Self-reported Nicotine Consumption
timeFrame: After 3rd treatment day
measure: Self-reported Nicotine Consumption
timeFrame: After 4th treatment day
measure: Carbon Monoxide (CO)- Evaluated Nicotine Consumption
timeFrame: Baseline
measure: Carbon Monoxide (CO)- Evaluated Nicotine Consumption
timeFrame: Day 1
measure: Carbon Monoxide (CO)- Evaluated Nicotine Consumption
timeFrame: Day 2
measure: Carbon Monoxide (CO)- Evaluated Nicotine Consumption
timeFrame: Day 3
measure: Carbon Monoxide (CO)- Evaluated Nicotine Consumption
timeFrame: Day 4
measure: Carbon Monoxide (CO)- Evaluated Nicotine Consumption
timeFrame: Day 5
measure: Nicotine Dependence
timeFrame: Baseline
measure: Nicotine Dependence
timeFrame: End of the treatment (On the fifth day, after completing 20 TMS sessions)
measure: Nicotine Dependence
timeFrame: 1 week follow up
measure: Nicotine Dependence
timeFrame: 1 month follow up
measure: Nicotine Dependence
timeFrame: 6 months follow up
measure: Momentary Craving
timeFrame: Baseline
measure: Momentary Craving
timeFrame: Day 1
measure: Momentary Craving
timeFrame: Day 2
measure: Momentary Craving
timeFrame: Day 3
measure: Momentary Craving
timeFrame: Day 4
measure: Momentary Craving
timeFrame: Day 5
measure: General Craving
timeFrame: Baseline
measure: General Craving
timeFrame: End of the treatment (On the fifth day, after completing 20 TMS sessions)
measure: General Craving
timeFrame: 1 week follow up
measure: General Craving
timeFrame: 1 month follow up
measure: General Craving
timeFrame: 6 months follow up
Secondary outcomes:
measure: Perceived Stress
timeFrame: Baseline
measure: Perceived Stress
timeFrame: End of the treatment (On the fifth day, after completing 20 TMS sessions)
measure: Perceived Stress
timeFrame: 1 week follow up
measure: Perceived Stress
timeFrame: 1 month follow up
measure: Perceived Stress
timeFrame: 6 months follow up
measure: Motivation to Quit Smoking
timeFrame: Baseline
measure: Motivation to Quit Smoking
timeFrame: End of the treatment (On the fifth day, after completing 20 TMS sessions)
measure: Motivation to Quit Smoking
timeFrame: 1 week follow up
measure: Motivation to Quit Smoking
timeFrame: 1 month follow up
measure: Motivation to Quit Smoking
timeFrame: 6 months follow up
Other outcomes:
Locations:
city: Larnaca
country: Cyprus
facility: Cyprus rTMS
Study officials:
affiliation: Maastricht University, The Netherlands
name: Alexander Sack
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.