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Investigating a personalized smoking cessation treatment based on neurocognitive profile: an innovative deep cTBS study

Investigating a personalized smoking cessation treatment based on neurocognitive profile: an innovative deep cTBS study - Insula inhibition for smoking cessation

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57086
Enrollment
112
Registered
2024-10-22
Start date
2026-01-19
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

smoking addiction Tobacco use disorder

Interventions

Participants are randomized to 1 of 3 conditions
1) active cTBS of the left insula, 2) active cTBS of the right insula, or 3) sham stimulation of the left or right insula. All participants will receive additional motivational interviewing.

Sponsors

Universiteiten
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Age 25-55 years Smoking at least 10 filter cigarettes per day Smoking for at least 10 years Fagerstrom Test for Nicotine Dependence score of at least 3 Primarily smoking filter cigarettes and nog any other form of tobacco Desire to quit smoking Having at least one quit attempt using an evidence-based treatment

Exclusion criteria

Exclusion criteria: Previous experience with TMS Primarily smoking tobacco products other than filter cigarettes, such as shag, cigars, e-cigarettes and cannabis Currently undergoing other treatment to quit smoking Current diagnosis or last year treatment for a psychiatric disorder Suffering from a neurological disorder Heavy use or possible dependence on alcohol Heavy use or possible dependence on substances other than tobacco TMS and MRI contraindications, including: o Cardiac demand pacemakers, implanted defibrillators, or other electronic implants. o History of seizure or heat convulsion. o History of epilepsy or seizure in first degree relatives; Receiving or requiring antiepileptic drugs. o History of head injury. o History of metal implants in the head (except dental fillings). o Known history of any metallic particles in the eye, implanted cardiac pacemakers or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps. o Hearing loss or history of hearing loss. o Known history of cochlear implants o Known or possible pregnancy o Systemic and metabolic disorders. o Any known factor that lowers the threshold for epileptic seizures (e.g. psychotropic medications, sleep deprivation, caffeine, substance abuse, etc.). o Irremovable prosthesis. o Irremovable piercings. o Irremovable medicine patches o IUDs placed within 6 weeks or material other than copper. o Irremovable dentures. o Implanted lenses in the eye. o Bone screws or plates. o Metal particles in the eye or they body. o Tinnitus o Inadequate communication with the patient

Design outcomes

Primary

MeasureTime frame
Days untill relapse, number of smoked cigarettes and craving

Secondary

MeasureTime frame
Abstinence (yes/no), number of abstinent days, degree of tobacco dependence, withdrawal symptoms, cognitive control, craving, goal-directed behavior, neurobiological measures (brain network activity, brain activity involved in cognitive control and craving, dACC glutamate concentrations), craving after cTBS session.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026