Accelerated iTBS in Smoking Cessation

NCT ID: NCT05271175

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-19
• Study Completion Date: 2020-09-07

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.

Conditions

Nicotine Dependence; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active TMS & Neutral videos

Received active iTBS stimulation while watching neutral videos

Group Type: EXPERIMENTAL

Active intermittent theta burst stimulation

Intervention Type: 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 & Smoking videos

Received active iTBS stimulation while watching smoking-related videos

Group Type: EXPERIMENTAL

Active intermittent theta burst stimulation

Intervention Type: 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.

Sham TMS & Smoking videos

Received sham stimulation while watching smoking-related videos

Group Type: SHAM_COMPARATOR

Sham intermittent theta burst stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cyprus rTMS Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Sack

Role: PRINCIPAL_INVESTIGATOR

Maastricht University, The Netherlands

Locations

Cyprus rTMS

Larnaca, , Cyprus

Countries

Cyprus

References

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.

Reference Type: DERIVED

PMID: 35686190 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

08.2019CY

Identifier Type: -

Identifier Source: org_study_id