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Accelerated rTMS for the Reduction of Nicotine Craving

Primary Purpose

Nicotine Use Disorder, Nicotine Dependence

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active rTMS with MagVenture MagPro double blind rTMS system
Sham rTMS
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Use Disorder focused on measuring TMS, rTMS, Transcranial Magnetic Stimulation, Smoking, Nicotine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Outpatient Adults aged 18-70
  • Cigarette Smokers smoking at least 1 pack (20 cigarettes a day) with current smoking status confirmed by exhaled CO reading of >10ppm day of visit.
  • Ability to provide informed consent

Exclusion Criteria

  • Current treatment with varenicline or bupropion
  • Currently making a smoking quit attempt (not currently smoking).
  • Current treatment with an antidepressant, anti-convulsant, anxiolytic, antipsychotic or mood stabilizer.
  • Current episode of major depression determined by MINI interview.
  • Current or past history of schizophrenia, schizoaffective disorder, anorexia nervosa, bulimia or bipolar disorder as determined by MINI.
  • Current daily consumption of alcohol or current alcohol use disorder.
  • Current substance use disorder except for nicotine or cannabis use disorder.
  • Currently pregnant or lactating.
  • Contraindications to rTMS including history of seizure, metal implanted above the neck, pacemaker or any brain lesion.
  • Unstable medical conditions
  • Suicidal ideation or history of suicide attempt within the last six months.
  • Inability or unwillingness of subject or legal guardian/representative to give informed consent

Sites / Locations

  • MUSC Institute of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active rTMS

Sham

Arm Description

5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.

5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.

Outcomes

Primary Outcome Measures

Tolerability Measured by Percent of Participants Completing the rTMS Course
Percent of participants completing the 5 session rTMS course. Hypothesize >75% of participants will complete the 5 treatments.
Decrease in Cue Induced Nicotine Craving
Nicotine craving evaluated using Questionnaire on Smoking Urges- Brief (QSU-B) questions modified to a 0-100 analog rating. Higher scores meaning a higher level of craving.

Secondary Outcome Measures

Reduce in Self Reported Smoking
An exploratory outcome will be the determination if participants receiving active rTMS report decreased levels of smoking 1 week and 2 weeks after rTMS course.

Full Information

First Posted
November 8, 2017
Last Updated
October 14, 2019
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03352609
Brief Title
Accelerated rTMS for the Reduction of Nicotine Craving
Official Title
Accelerated Repetitive Transcranial Magnetic Stimulation (rTMS) of the Dorsolateral Prefrontal Cortex for the Reduction of Craving in Nicotine Dependent Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Investigator completing residency program and leaving for a new job
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
December 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose if this study is to determine if five treatments of repetitive transcranial magnetic stimulation (rTMS) can reduce craving for cigarettes in smokers. rTMS uses magnetic pulses to stimulate the brain and is currently approved for the treatment of major depressive disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Use Disorder, Nicotine Dependence
Keywords
TMS, rTMS, Transcranial Magnetic Stimulation, Smoking, Nicotine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double blind, control
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomized double blind control using a sham rTMS system
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active rTMS
Arm Type
Experimental
Arm Description
5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.
Intervention Type
Device
Intervention Name(s)
Active rTMS with MagVenture MagPro double blind rTMS system
Intervention Description
5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Intervention Description
Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads
Primary Outcome Measure Information:
Title
Tolerability Measured by Percent of Participants Completing the rTMS Course
Description
Percent of participants completing the 5 session rTMS course. Hypothesize >75% of participants will complete the 5 treatments.
Time Frame
1 day (single visit)
Title
Decrease in Cue Induced Nicotine Craving
Description
Nicotine craving evaluated using Questionnaire on Smoking Urges- Brief (QSU-B) questions modified to a 0-100 analog rating. Higher scores meaning a higher level of craving.
Time Frame
During the one day visit
Secondary Outcome Measure Information:
Title
Reduce in Self Reported Smoking
Description
An exploratory outcome will be the determination if participants receiving active rTMS report decreased levels of smoking 1 week and 2 weeks after rTMS course.
Time Frame
1 week and 2 weeks after rTMS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatient Adults aged 18-70 Cigarette Smokers smoking at least 1 pack (20 cigarettes a day) with current smoking status confirmed by exhaled CO reading of >10ppm day of visit. Ability to provide informed consent Exclusion Criteria Current treatment with varenicline or bupropion Currently making a smoking quit attempt (not currently smoking). Current treatment with an antidepressant, anti-convulsant, anxiolytic, antipsychotic or mood stabilizer. Current episode of major depression determined by MINI interview. Current or past history of schizophrenia, schizoaffective disorder, anorexia nervosa, bulimia or bipolar disorder as determined by MINI. Current daily consumption of alcohol or current alcohol use disorder. Current substance use disorder except for nicotine or cannabis use disorder. Currently pregnant or lactating. Contraindications to rTMS including history of seizure, metal implanted above the neck, pacemaker or any brain lesion. Unstable medical conditions Suicidal ideation or history of suicide attempt within the last six months. Inability or unwillingness of subject or legal guardian/representative to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Friedrich, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUSC Institute of Psychiatry
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Accelerated rTMS for the Reduction of Nicotine Craving

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