Enhancing Relapse Prevention for Smoking Cessation With Repetitive Transcranial Magnetic Stimulation

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

Interventions

DEVICE

rTMS Active 20Hz

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.

DEVICE

rTMS Sham

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Virginia Tech Carilion School of Medicine and Research Institute

  collaborator OTHER

• The City College of New York

  lead OTHER

Principal Investigators

• Christine E Sheffer, PhD · CCNY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2016-06-30

Completion

2016-06-30

Countries

• United States

Study Locations