Ignite Creation Date:
2024-05-06 @ 1:39 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04083144
Status:
COMPLETED
Last Update Posted:
2023-04-05
First Post:
2019-09-06
Brief Title:
Deep rTMS and Varenicline for Smoking Cessation
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
Deep rTMS and Varenicline for Smoking Cessation A Pilot Study Exploring the Efficacy of a Combined Treatment Approach
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
This study will be a randomized double-blind sham-controlled clinical trial Nicotine dependent participants will be recruited and randomized tor receive either active or sham rTMS intervention for 4 weeks 5 sessionsweek All participants will receive an open-label treatment of varenicline for 12 weeks and weekly counselling sessions The aims of the study are
1 To examine the efficacy of bilateral deep rTMS to the insula on point prevalence smoking abstinence in smokers receiving varenicline treatment
2 To examine the efficacy of bilateral deep rTMS to the insula on other smoking outcomes such as craving cigarette smoking and dependence severity
3 To examine the effect of bilateral deep rTMS to the insula on abstinence at the end of rTMS treatment and at 6-month follow up
Abstinence will be measured by point prevalence at week 4 and 12 and prolonged continuous abstinence at week 26 This will be confirmed using plasma cotinine levels All other measures will be done using various questionnaires such as Fagerstrom Test of Nicotine Dependence FTND Timeline Follow-Back TLFB Minnesota Nicotine Withdrawal Scale MNWS and Tiffany Questionnaire of Smoking Urges T-QSU
1 To examine the efficacy of bilateral deep rTMS to the insula on point prevalence smoking abstinence in smokers receiving varenicline treatment
2 To examine the efficacy of bilateral deep rTMS to the insula on other smoking outcomes such as craving cigarette smoking and dependence severity
3 To examine the effect of bilateral deep rTMS to the insula on abstinence at the end of rTMS treatment and at 6-month follow up
Abstinence will be measured by point prevalence at week 4 and 12 and prolonged continuous abstinence at week 26 This will be confirmed using plasma cotinine levels All other measures will be done using various questionnaires such as Fagerstrom Test of Nicotine Dependence FTND Timeline Follow-Back TLFB Minnesota Nicotine Withdrawal Scale MNWS and Tiffany Questionnaire of Smoking Urges T-QSU
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None