Accelerated rTMS for the Reduction of Nicotine Craving

NCT03352609 | Terminated Results FDA Device

• 1 other identifier: 00070449
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Use Disorder; Nicotine Dependence

Keywords

TMS; rTMS; Transcranial Magnetic Stimulation; Smoking; Nicotine

Outcome Measures

Primary Outcomes (2)

• 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.

  1 day (single visit)

• 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.

  During the one day visit

Secondary Outcomes (1)

• Reduce in Self Reported Smoking

  1 week and 2 weeks after rTMS

Study Arms (2)

Active rTMS

EXPERIMENTAL

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.

Device: Active rTMS with MagVenture MagPro double blind rTMS system

Sham

SHAM COMPARATOR

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

Device: Sham rTMS

Interventions

Active rTMS with MagVenture MagPro double blind rTMS system DEVICE

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.

Active rTMS

Sham rTMS DEVICE

Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads

Sham

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

MUSC Institute of Psychiatry

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Dr Friedrich
• Organization: MUSC

friedric@musc.edu

843-792-9888

Study Officials

• David Friedrich, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized double blind control using a sham rTMS system
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Model Details: Randomized, double blind, control

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 24, 2017
• Study Start: January 1, 2018
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: October 15, 2019
• Results First Posted: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)