Transcranial Magnetic Stimulation for Nicotine Dependence: An Effectiveness-Implementation Trial

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 1, 2024

Primary Completion Date

August 1, 2026

Study Completion Date

September 1, 2026

Conditions
Tobacco Use DisorderPsychiatric DisorderNicotine Dependence
Interventions
DEVICE

Brainsway H4 deep Repetitive Transcranial Magnetic Stimulation (rTMS) coil

"An rTMS treatment course consisting of daily treatment, 5 days per week, for 3 weeks, followed by once weekly treatments for 3 weeks, for a total of 18 treatment sessions over 6 weeks.~Sixty trains of 30 pulses each (total 1,800 pulses) will be applied at 10 Hz, for 3 second trains, with a 15 second inter-train interval, for approximately 18 minutes of treatment time.~At each rTMS treatment session, prior to stimulation, participants will undergo a smoking craving provocation procedure where they will be asked to close their eyes and imagine one of their triggers for 30 seconds. Following this they will watch a presentation of smoking pictures for 2 minutes and 30 seconds. Thus, the entire craving provocation procedure will be 3 minutes prior to stimulation start.~Brief behavioural support will be available to the participant on a weekly basis by a trained research staff member."

DRUG

Nicotine replacement

"Each participant will receive individualized NRT treatment through the advice of their study physician for 6 weeks. The study physician, in discussion with the participant, will decide the type, dosage, and combination of NRT to provide to the participant.~NRT provided can include:~* Patch (7mg, 14mg, and 21mg)~* Gum (2mg)~* Lozenge (2mg)~* Inhaler (10mg; 4mg of nicotine delivered)"

All Listed Sponsors
lead

Centre for Addiction and Mental Health

OTHER

NCT06534047 - Transcranial Magnetic Stimulation for Nicotine Dependence: An Effectiveness-Implementation Trial | Biotech Hunter | Biotech Hunter