At a glance
ClinicalIndex Comparison Record- ✓Age 18-65 years
- ✓Nicotine dependence as defined by DSM-V criteria
- ✓Daily cigarette consumption ≥10 cigarettes per day with exhaled CO ≥10 ppm
- ✓Fagerstrom Test of Nicotine Dependence score ≥4
- ✕Smoking abstinence for ≥3 months prior to screening
- ✕Current use of other smoking cessation medications or aids
- ✕Allergy or contraindication to varenicline or rTMS
- ✕Pregnancy, attempting pregnancy, or breastfeeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Deep rTMS and Varenicline for Smoking Cessation: A Pilot Study Exploring the Efficacy of a Combined Treatment Approach
In Brief
A clinical study evaluating Deep Repetitive Transcranial Magnetic Stimulation (Active), Deep Repetitive Transcranial Magnetic Stimulation (Sham), and 1 other intervention for Tobacco Use Disorder and Smoking Cessation. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The purpose of this study is to investigate the effect of deep repetitive transcranial magnetic stimulation (rTMS) using the insula H-coil on smoking outcomes in smokers receiving varenicline. It is hypothesized that active deep rTMS will improve abstinence rates, attenuate craving and reduce cigarette consumption and dependence severity.
Study Details
Timeline
Interventions
Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Sham deep rTMS using the H-coil. The sham coil is built into the same helmet as the active coil. It mimics the active coil with regards to acoustics and scalp sensations.
12 week course treatment of varenicline (0.5 mg/1 mg) using the standard dosage schedule for smoking cessation (Day 1-3: 0.5 mg daily; day 4-7: 0.5 mg twice a day; day 8-end of treatment: 1 mg twice a day).