Enhancing Relapse Prevention for Smoking Cessation With Repetitive Transcranial Magnetic Stimulation

NCT02822703 | Completed

• 2 other identifiers: 639308R21CA178813
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Tobacco use is one of the most significant cancer control and public health challenges in the US today. Half of all smokers in the US will attempt to quit tobacco each year, but fully 95% of those who attempt to quit will reverse this decision within 12 months and choose the transient, albeit immediately rewarding activity of smoking at the cost of much larger long-term rewards such as future health and long life. This project seeks to improve scientific knowledge of these decision-making processes and potentially improve the treatment of tobacco dependence by examining the feasibility of using a brain stimulation technique, repetitive Transcranial Magnetic Stimulation or rTMS to improve the efficacy of an existing evidence-based relapse prevention intervention. rTMS is an FDA-cleared treatment for medication resistant depression and is being examined as a treatment for a variety of other disorders. This study will utilize an intensity and duration of rTMS that is well within the safety parameters and similar in location and intensity to that used in previous studies with smokers to reduce cigarette consumption.

Conditions

Smoking Cessation

Keywords

smoking cessation; tobacco use disorder; delay discounting; repetitive transcranial magnetic stimulation; relapse prevention

Outcome Measures

Primary Outcomes (1)

• Latency to relapse

  Abstinence will be assessed with latency to relapse (days from Quit Date to relapse or 7 consecutive days of smoking after a 24 hour quit attempt)

  3.5 months following scheduled quit date

Study Arms (2)

Active 20Hz

EXPERIMENTAL

The rTMS device used in this study is the Mastim Super Rapid2 Stimulator with a 70mm Double Air Film Coil. Guidelines indicate that the maximum safe duration of a single train of 20Hz at 110% of the Motor Threshold (MT) is 1.6 seconds. In this study, the stimulator and the coils will be used to stimulate neurons in the left dorsolateral prefrontal cortex (DLPFC), the same location in the brain as that stimulated in the studies supporting the efficacy of this treatment in depression, in order to examine the feasibility of testing this intervention for efficacy in the treatment of tobacco dependence.

Device: rTMS Active 20Hz

Sham

SHAM COMPARATOR

The rTMS sham coil used in this study is manufactured by Magstim and currently classified as an investigational device. There is no intention to treat or prevent a disease and/or alter a function in the body with the sham stimulation provided by the sham coil. In this project, the sham coil will be placed in the same location in the brain as that stimulated in the studies supporting the efficacy of this treatment for depression.

Device: rTMS Sham

Interventions

rTMS Active 20Hz DEVICE

Active stimulation will be delivered with 70mm Double Air Film Coils. Participants will attend eight 20Hz sessions within two weeks of the scheduled quit date. Participants will receive 20Hz at 110% of the MT for 1 second, less than the limits indicated in the guidelines. These stimulation parameters have been utilized with no serious adverse events in previous studies to decrease delay discounting among smokers and non-smokers. These parameters are similar to or less intense than those utilized in other smoking cessation studies. All participants will receive rTMS over the same area of the DLPFC (6cm anterior to the MT area) while reading relapse prevention booklets supervised by the study coordinator.

Active 20Hz

rTMS Sham DEVICE

The sham stimulation uses a similar 70mm Double Air Film Coil to look and sound like the active coil, but the magnetic field produced by the sham coil is markedly attenuated (only 5% of stimulator output setting: that is 2.25% of the maximum stimulator output (5% of 45% = 2.25%) and biologically inactive. Participants in this condition will attend eight sham sessions within two weeks of their scheduled quit date. During these sessions, they will also read relapse prevention booklets supervised by the study coordinator. The sham coil is not intended to and does not produce a stimulation effect so there is no proposed biologic mechanism of action.

Sham

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Are fluent in English and be able to read English at the 8th grade level
• Pass the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TASS)
• Report smoking 5-20 cigarettes daily
• Intend to quit smoking in the next 30 days
• Report a motivation level to quit of ≥7 (scale 0-10)
• Pass a urine drug screen for drugs of abuse (marijuana, cocaine, opioids, amphetamines, etc.)
• No plans to move from the area NYC area in the next 4 months and have a consistent, reliable method of communication so that study staff can successfully contact them

You may not qualify if:

• self-reported claustrophobia
• personal history of epilepsy
• use of anticonvulsant medication
• head injury, aneurysm, stroke, or previous cranial neurosurgery
• diagnosis of major depressive disorder, bipolar disorder, a schizophrenia-spectrum disorder, tinnitus, or migraines
• metal implants in the head, neck, or cochlea; a pacemaker
• currently taking medications that lower seizure threshold (i.e., such as tricyclic antidepressants or bupropion)
• known pre-existing noise induced hearing loss or concurrent treatment of ototoxic medications (i.e., Aminoglycosides, Cisplatine)
• currently using medications for tobacco cessation (i.e., nicotine replacement, bupropion, varenicline, etc.)
• pregnant or planning to become pregnant in the next 12 weeks
• current regular use of forms of tobacco other than cigarettes

Sponsors & Collaborators

• The City College of New York: lead
• National Cancer Institute (NCI): collaborator
• Virginia Tech Carilion School of Medicine and Research Institute: collaborator

Study Sites (1)

The City College of New York

New York, New York, 10031, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

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

Study Officials

• Christine E Sheffer, PhD

  CCNY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Medical Professor

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 4, 2016
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 4, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)