N/A
Completed N=42
Deep rTMS and Varenicline for Smoking Cessation
Source: ClinicalTrials.gov NCT04083144 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Point Prevalence Abstinence at the End of 12 Weeks — 12; 6; 5; 9 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Point Prevalence Abstinence at the End of 12 Weeks |
12; 6; 5; 9 | — |
| SECONDARY Fagerstrom Test For Nicotine Dependence (FTND) Score |
0.636; 1.468 | 0.98 |
| SECONDARY Expired CO Measurements |
8.457; 8.124 | 0.76 |
| SECONDARY Cigarettes Per Day (TLFB) |
3.877; 4.29 | 0.98 |
| SECONDARY Minnesota Nicotine Withdrawal Scale (MNWS) Score |
8.291; 9.372 | 0.24 |
| SECONDARY Tiffany Questionnaire for Smoking Urges (T-QSU) Score |
61.683; 73.236 | 0.26 |
| SECONDARY Point Prevalence Abstinence at the End of 4 Weeks |
11; 9; 7; 7 | — |
| SECONDARY Prolonged Abstinence From End of Treatment (Week 12) to End of Follow up (Week 26) |
5; 4; 11; 11 | — |
| SECONDARY Prolonged Abstinence With 2-week Grace Period at End of Follow up (Week 26) |
5; 4; 11; 11 | — |
| SECONDARY Continuous Abstinence at 6 Months |
5; 4; 11; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-65;
- Nicotine dependent as assessed by Diagnostic and Statistical Manual of Mental Disorders (DSM-V);
- Reported daily cigarette consumption ≥ 10 and expired carbon monoxide (CO) measurement of ≥ 10 ppm;
- Fagerstrom Test of Nicotine Dependence (FTND) ≥ 4;
- Reported motivation to quit within 30 days as assessed using the Contemplation Ladder score of ≥ 7.
Exclusion Criteria
- Reported smoking abstinence in the 3 months preceding screening visit;
- Current use of other smoking cessation aids;
- Allergy and/or contraindication to varenicline or rTMS;
- Pregnancy, trying to become pregnant or breastfeeding;
- Current or recent history of cardiovascular or cerebrovascular disease and/or current hypertension;
- Current or historical evidence of suicidal behavior;
- Serious current or personal history of medical condition/disease (neurological disorders, brain lesions, multiple sclerosis, head trauma, loss of consciousness, hearing loss, etc.);
- Current, personal history or family history of seizures;
- Cognitive impairment as defined as a Mini Mental State Examination (MMSE) score <24;
- Concomitant use of medication that lowers seizure threshold
Data sourced from ClinicalTrials.gov (NCT04083144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.