Trial Outcomes & Findings for Deep rTMS and Varenicline for Smoking Cessation (NCT NCT04083144)
NCT ID: NCT04083144
Last Updated: 2024-11-04
Results Overview
Measured by self-report of smoking abstinence in the past 7 days and confirmed using plasma cotinine measurement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-11-04
Participant Flow
50 participants were enrolled, however, 8 of them were lost to follow up before randomization and therefore were not assigned to any group.
Participant milestones
| Measure |
Deep rTMS Active + Varenicline
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Varenicline: 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).
|
Deep rTMS Sham + Varenicline
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Sham): 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.
Varenicline: 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).
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
18
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Deep rTMS and Varenicline for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Deep rTMS Active + Varenicline
n=24 Participants
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Varenicline: 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).
|
Deep rTMS Sham + Varenicline
n=18 Participants
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Sham): 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.
Varenicline: 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).
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 12.5 • n=39 Participants
|
46.2 years
STANDARD_DEVIATION 12.9 • n=41 Participants
|
44.8 years
STANDARD_DEVIATION 13.16 • n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Education Level
Less than grade 8
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Education Level
Highschool
|
8 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Education Level
College/University/Grad School
|
15 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
|
Education Years
|
14.8 years
STANDARD_DEVIATION 3.6 • n=39 Participants
|
14.5 years
STANDARD_DEVIATION 2.8 • n=41 Participants
|
14.7 years
STANDARD_DEVIATION 3.05 • n=35 Participants
|
|
Employment Status
Employed
|
15 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
|
Employment Status
Unemployed
|
6 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Employment Status
Retired
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Housing
House
|
7 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Housing
Apartment
|
15 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
|
Housing
Condo
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Income
<19,999
|
7 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Income
20,000-49,999
|
9 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Income
50,000-74,999
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Income
>75,000
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Marital Status
Married/Common Law
|
6 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Marital Status
Separated/Divorced/Annulled
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Marital Status
Never Married
|
12 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Fagerström Test for Nicotine Dependence
|
5.6 Score out of 10
STANDARD_DEVIATION 1.5 • n=39 Participants
|
6.3 Score out of 10
STANDARD_DEVIATION 1.4 • n=41 Participants
|
5.9 Score out of 10
STANDARD_DEVIATION 1.47 • n=35 Participants
|
|
Mini-mental state examination
|
28.5 Score out of 30
STANDARD_DEVIATION 1.5 • n=39 Participants
|
28.4 Score out of 30
STANDARD_DEVIATION 1.5 • n=41 Participants
|
28.5 Score out of 30
STANDARD_DEVIATION 1.4 • n=35 Participants
|
|
Smoking Contemplation Ladder
|
9 Score out of 10
STANDARD_DEVIATION 1 • n=39 Participants
|
9 Score out of 10
STANDARD_DEVIATION 1 • n=41 Participants
|
9 Score out of 10
STANDARD_DEVIATION 1 • n=35 Participants
|
|
CO Measurement
|
24.7 ppm
STANDARD_DEVIATION 13.9 • n=39 Participants
|
24.3 ppm
STANDARD_DEVIATION 11.3 • n=41 Participants
|
24.5 ppm
STANDARD_DEVIATION 11.9 • n=35 Participants
|
|
Cigarettes/day
|
16.9 Cigarettes/day
STANDARD_DEVIATION 5.3 • n=39 Participants
|
19.4 Cigarettes/day
STANDARD_DEVIATION 1.3 • n=41 Participants
|
18.0 Cigarettes/day
STANDARD_DEVIATION 4.8 • n=35 Participants
|
|
Alcoholic Drinks/day
|
1.1 Drinks/day
STANDARD_DEVIATION 1.7 • n=39 Participants
|
1.3 Drinks/day
STANDARD_DEVIATION 1.6 • n=41 Participants
|
1.2 Drinks/day
STANDARD_DEVIATION 1.6 • n=35 Participants
|
|
Nicotine Metabolite Ratio
|
0.50 Ratio 0-1
STANDARD_DEVIATION 0.3 • n=39 Participants
|
0.55 Ratio 0-1
STANDARD_DEVIATION 0.22 • n=41 Participants
|
0.52 Ratio 0-1
STANDARD_DEVIATION 0.25 • n=35 Participants
|
PRIMARY outcome
Timeframe: 12 weeksMeasured by self-report of smoking abstinence in the past 7 days and confirmed using plasma cotinine measurement.
Outcome measures
| Measure |
Deep rTMS Active + Varenicline
n=17 Participants
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Varenicline: 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).
|
Deep rTMS Sham + Varenicline
n=15 Participants
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Sham): 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.
Varenicline: 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).
|
|---|---|---|
|
Point Prevalence Abstinence at the End of 12 Weeks
Abstinent
|
12 Participants
|
6 Participants
|
|
Point Prevalence Abstinence at the End of 12 Weeks
Non-abstinent
|
5 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 26 weeksThis will be used to assess physical dependence severity in participants. It is a 6 item scale and total scores can range from 0-10. A higher score indicates more severe nicotine dependence.
Outcome measures
| Measure |
Deep rTMS Active + Varenicline
n=24 Participants
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Varenicline: 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).
|
Deep rTMS Sham + Varenicline
n=18 Participants
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Sham): 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.
Varenicline: 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).
|
|---|---|---|
|
Fagerstrom Test For Nicotine Dependence (FTND) Score
|
0.636 score on a scale
Standard Error 0.447
|
1.468 score on a scale
Standard Error 0.47
|
SECONDARY outcome
Timeframe: 26 weeksThis will be used as a biological confirmation of recent smoking.
Outcome measures
| Measure |
Deep rTMS Active + Varenicline
n=24 Participants
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Varenicline: 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).
|
Deep rTMS Sham + Varenicline
n=18 Participants
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Sham): 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.
Varenicline: 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).
|
|---|---|---|
|
Expired CO Measurements
|
8.457 ppm
Standard Error 2.5
|
8.124 ppm
Standard Error 2.624
|
SECONDARY outcome
Timeframe: 26 weeksSelf-reported measure of cigarette consumption.
Outcome measures
| Measure |
Deep rTMS Active + Varenicline
n=24 Participants
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Varenicline: 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).
|
Deep rTMS Sham + Varenicline
n=18 Participants
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Sham): 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.
Varenicline: 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).
|
|---|---|---|
|
Cigarettes Per Day (TLFB)
|
3.877 cigarettes/day
Standard Error 1.179
|
4.29 cigarettes/day
Standard Error 1.265
|
SECONDARY outcome
Timeframe: 26 weeksThis will be used to assess withdrawal symptoms. It is an 8 item scale and total scores range from 0 to 24. A higher score indicates more severe nicotine withdrawal.
Outcome measures
| Measure |
Deep rTMS Active + Varenicline
n=24 Participants
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Varenicline: 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).
|
Deep rTMS Sham + Varenicline
n=18 Participants
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Sham): 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.
Varenicline: 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).
|
|---|---|---|
|
Minnesota Nicotine Withdrawal Scale (MNWS) Score
|
8.291 score on a scale
Standard Error 1.922
|
9.372 score on a scale
Standard Error 2.107
|
SECONDARY outcome
Timeframe: 26 weeksThis will be used to assess symptoms of craving/urges for tobacco. It is a 32 item scale and total scores range from 0 to 224. A higher score indicates more severe smoking craving/urges.
Outcome measures
| Measure |
Deep rTMS Active + Varenicline
n=24 Participants
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Varenicline: 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).
|
Deep rTMS Sham + Varenicline
n=18 Participants
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Sham): 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.
Varenicline: 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).
|
|---|---|---|
|
Tiffany Questionnaire for Smoking Urges (T-QSU) Score
|
61.683 score on a scale
Standard Error 9.624
|
73.236 score on a scale
Standard Error 10.311
|
SECONDARY outcome
Timeframe: 4 weeksMeasured by self-report of smoking abstinence in the past 7 days and confirmed using plasma cotinine measurement.
Outcome measures
| Measure |
Deep rTMS Active + Varenicline
n=18 Participants
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Varenicline: 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).
|
Deep rTMS Sham + Varenicline
n=16 Participants
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Sham): 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.
Varenicline: 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).
|
|---|---|---|
|
Point Prevalence Abstinence at the End of 4 Weeks
Abstinent
|
11 Participants
|
9 Participants
|
|
Point Prevalence Abstinence at the End of 4 Weeks
Non-abstinent
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 26 weeksMeasured by self-report of smoking abstinence since the last visit and confirmed using plasma cotinine measurement.
Outcome measures
| Measure |
Deep rTMS Active + Varenicline
n=16 Participants
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Varenicline: 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).
|
Deep rTMS Sham + Varenicline
n=15 Participants
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Sham): 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.
Varenicline: 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).
|
|---|---|---|
|
Prolonged Abstinence From End of Treatment (Week 12) to End of Follow up (Week 26)
Abstinent
|
5 Participants
|
4 Participants
|
|
Prolonged Abstinence From End of Treatment (Week 12) to End of Follow up (Week 26)
Non-abstinent
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 26 weeksMeasured by self-report of smoking abstinence since the last visit and confirmed using plasma cotinine measurement.
Outcome measures
| Measure |
Deep rTMS Active + Varenicline
n=16 Participants
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Varenicline: 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).
|
Deep rTMS Sham + Varenicline
n=15 Participants
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Sham): 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.
Varenicline: 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).
|
|---|---|---|
|
Prolonged Abstinence With 2-week Grace Period at End of Follow up (Week 26)
Non-abstinent
|
11 Participants
|
11 Participants
|
|
Prolonged Abstinence With 2-week Grace Period at End of Follow up (Week 26)
Abstinent
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 26 weeksMeasured by self-report of smoking abstinence since the last visit and confirmed using plasma cotinine measurement.
Outcome measures
| Measure |
Deep rTMS Active + Varenicline
n=16 Participants
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Varenicline: 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).
|
Deep rTMS Sham + Varenicline
n=15 Participants
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Sham): 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.
Varenicline: 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).
|
|---|---|---|
|
Continuous Abstinence at 6 Months
Abstinent
|
5 Participants
|
4 Participants
|
|
Continuous Abstinence at 6 Months
Non-abstinent
|
11 Participants
|
11 Participants
|
Adverse Events
Deep rTMS Active + Varenicline
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Deep rTMS Sham + Varenicline
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Deep rTMS Active + Varenicline
n=24 participants at risk
Participants undergoing deep rTMS (active) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Active): Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
Varenicline: 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).
|
Deep rTMS Sham + Varenicline
n=18 participants at risk
Participants undergoing deep rTMS (sham) for 4 weeks (5 sessions/week) along with 12 weeks of varenicline.
Deep Repetitive Transcranial Magnetic Stimulation (Sham): 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.
Varenicline: 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).
|
|---|---|---|
|
Nervous system disorders
Nausea
|
33.3%
8/24 • Number of events 8 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
Nervous system disorders
Headache
|
16.7%
4/24 • Number of events 4 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
33.3%
6/18 • Number of events 6 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
Product Issues
Vivid Dreams
|
16.7%
4/24 • Number of events 4 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
Product Issues
Sleep Disturbances
|
8.3%
2/24 • Number of events 2 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
Product Issues
Diarrhea
|
8.3%
2/24 • Number of events 2 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
Product Issues
Fatigue
|
12.5%
3/24 • Number of events 3 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
Product Issues
Contispation/bloating
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
2/24 • Number of events 2 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
Psychiatric disorders
Low Mood
|
8.3%
2/24 • Number of events 2 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
Nervous system disorders
Dizzy
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Leg pain/leg cramp
|
8.3%
2/24 • Number of events 2 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
Product Issues
Nightmare
|
8.3%
2/24 • Number of events 2 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
0.00%
0/18 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Fever
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
0.00%
0/18 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Sore Throat
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
0.00%
0/18 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Runny Nose
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
0.00%
0/18 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Trouble Concentrating
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
0.00%
0/18 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Sweating
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
0.00%
0/18 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Chest Pain
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
0.00%
0/18 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Chills
|
0.00%
0/24 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Irritability
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
0.00%
0/18 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Joint Stiffness
|
0.00%
0/24 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Muscle Cramp
|
0.00%
0/24 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Phosphene
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
0.00%
0/18 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Face twitching
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
0.00%
0/18 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
Gastrointestinal disorders
Acid Reflux
|
0.00%
0/24 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Amoeba
|
0.00%
0/24 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Poor Memory
|
0.00%
0/24 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Dry Skin
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
0.00%
0/18 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
|
General disorders
Fentanyl Overdose
|
4.2%
1/24 • Number of events 1 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
0.00%
0/18 • Adverse events were collected from the start of the study until end of study involvement (i.e., 6 months)
|
Additional Information
Dr. Bernard Le Foll
Centre for Addiction and Mental Health
Phone: 4165358501
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place