Insula deep rTMS and varenicline for smoking cessation: A randomized control trial study protocol

Area of Science:

• Neuroscience
• Addiction Medicine
• Clinical Trials

Background:

• Current smoking cessation therapies offer limited long-term abstinence success.
• The insular cortex is a key brain region implicated in nicotine addiction.
• Non-invasive brain stimulation techniques, like rTMS, can modulate brain activity.

Purpose of the Study:

• To evaluate the efficacy of deep insula rTMS combined with varenicline for smoking cessation.
• To determine if this combination therapy improves long-term abstinence rates compared to standard treatments.
• To assess the safety and tolerability of deep insula rTMS in smokers undergoing cessation treatment.

Main Methods:

• A randomized, double-blind, sham-controlled clinical trial involving 50 participants with nicotine dependence.
• Participants received either active or sham deep rTMS targeting the insula for 4 weeks, alongside open-label varenicline for 12 weeks.
• Primary outcome: 7-day point prevalence abstinence at 12 weeks. Secondary outcomes included various measures of nicotine dependence, withdrawal, urges, and abstinence at 4 weeks and 6 months.

Main Results:

• This section is to be filled once the trial results are available.
• The study is designed to provide novel insights into the effectiveness of the intervention.
• Data collection covers the treatment period and a 6-month follow-up.

Conclusions:

• This trial represents the first investigation into the impact of deep insula rTMS on smoking cessation in individuals using varenicline.
• Findings will clarify the potential of combining deep insula rTMS with varenicline to enhance smoking abstinence rates.
• The study utilizes a specific H-coil for insula targeting, differentiating it from previous studies.