Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534047
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-07
Brief Title:
Transcranial Magnetic Stimulation for Nicotine Dependence An Effectiveness-Implementation Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Integrating Transcranial Magnetic Stimulation as a Treatment for Nicotine Dependence in the Clinic A Pragmatic Hybrid Effectiveness-Implementation Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tobacco smoking is the leading preventable cause of morbidity and mortality worldwide However currently available treatments including standard pharmacotherapy and behavioural support are limited in their efficacy tolerability and acceptability by patients Additionally tobacco use is substantially higher in individuals with comorbid mental illness constituting a particularly vulnerable population As such the development of multiple evidence-based treatments for smoking cessation is of upmost importance
Repetitive transcranial magnetic stimulation rTMS is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue As it can modulate neural circuits implicated in neuropsychiatric disorders it is a promising brain-based approach in the treatment of substance use disorders Recently a deep TMS coil has been cleared by the Food and Drug Administration FDA as efficacious for tobacco use disorder representing the first rTMS indication for addictions Before adoption of this intervention into smoking cessation clinics it is important to investigate whether implementation of rTMS into clinical care is feasible acceptable and appropriate for patients receiving care for nicotine dependence
The objective of this study is to compare the effectiveness of rTMS versus treatment as usual for patients with psychiatric disorders seeking treatment for smoking cessation Also barriers to the implementation of rTMS in routine clinical care will be examined by speaking with patients and health care providers on their experience with rTMS
Repetitive transcranial magnetic stimulation rTMS is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue As it can modulate neural circuits implicated in neuropsychiatric disorders it is a promising brain-based approach in the treatment of substance use disorders Recently a deep TMS coil has been cleared by the Food and Drug Administration FDA as efficacious for tobacco use disorder representing the first rTMS indication for addictions Before adoption of this intervention into smoking cessation clinics it is important to investigate whether implementation of rTMS into clinical care is feasible acceptable and appropriate for patients receiving care for nicotine dependence
The objective of this study is to compare the effectiveness of rTMS versus treatment as usual for patients with psychiatric disorders seeking treatment for smoking cessation Also barriers to the implementation of rTMS in routine clinical care will be examined by speaking with patients and health care providers on their experience with rTMS
Detailed Description:
The objective is to pilot a pragmatic randomized comparative effectiveness trial of rTMS compared to treatment as usual TAU for smoking cessation in individuals with psychiatric comorbidities using a type 1 hybrid effectiveness-implementation design Participants will be included if they meet DSM-5 criteria for mood disorders anxiety disorders psychotic disorders posttraumatic stress disorder obsessive compulsive disorders or other substance use disorders Those that undergo rTMS treatment will be offered open-label rTMS treatment with the FDA and Health Canada approved Brainsway deep TMS dTMS coil which includes 3 weeks of daily on-site rTMS treatments followed by 3 weeks of weekly treatments Those that undergo TAU will receive nicotine replacement therapy and counselling through the supervision of a study physician
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None