Real Time fMRI and Quitting Smoking

A Proof-of-concept Study of Real-time fMRI Neurofeedback Training for Smoking Cessation

This study will examine how real-time functional magnetic resonance imaging (rt-fMRI) feedback can be used to modulate brain activation in the context of smoking cues in order to resist craving. Participants will complete a total of three fMRI scanning sessions with a cue suppression task with or without neurofeedback training (NFT). Participants will be randomized to an active group (active NFT) or a control group (no NFT) during the scanning sessions. At the end of the third session, all participants will complete a validated smoking lapse laboratory paradigm to evaluate effects of NFT on smoking behavior.

Study Overview

• Status: Completed
• Conditions: Nicotine Use Disorder
• Intervention / Treatment: Behavioral: Realtime biofeedback using fMRI

Detailed Description

Smoking is the greatest preventable cause of mortality and a significant economic burden. Even with the best available treatments, most smokers relapse within days or weeks after a quit attempt. Nicotine replacement therapy, the most widely used pharmacotherapy, yields end of treatment quit rates of <25% suggesting that managing nicotine withdrawal is not sufficient. A smoker's response to smoking cues is one factor that increases risk of relapse. This study will examine how real-time functional magnetic resonance imaging (rt-fMRI) feedback can be used to modulate brain activation in the context of smoking cues in order to resist craving. First, we will conduct a pilot study in 12 smokers for technical development and to evaluate the feasibility of the proposed study procedures. Participants will complete a total of three fMRI scanning sessions with a cue suppression task with or without neurofeedback training (NFT). Participants will be randomized to an active group (active NFT) or a control group (no NFT) during the scanning sessions. At the end of the third session, all participants will complete a validated smoking lapse laboratory paradigm to evaluate effects of NFT on smoking behavior. Upon successful completion of the technical development phase, we will proceed to a proof-of-concept phase, which will recruit 72 smokers to evaluate the efficacy of NFT for smoking behavior.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Treatment-seeking smokers between the ages of 18 and 65, reporting consumption of at least 10 cigarettes per day for at least the past 6 months;
2. Planning to live in the area for at least the next month;
3. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form;
4. Able to communicate fluently in English (speaking, writing, and reading).

Exclusion Criteria:

Smoking Behavior:

1. Use of chewing tobacco or snuff or cigars;
2. Current enrollment or plans to enroll in another smoking cessation program or research study in the next month;
3. Current or anticipated (within the next month) use of smoking cessation medications or nicotine replacement therapy (NRT);
4. A baseline carbon monoxide (CO) reading less than 10ppm.

Alcohol/Drugs:

1. Current alcohol consumption that exceeds 25 standard drinks/week;
2. Positive breath alcohol concentration test (BrAC greater than or equal to 0.01) at intake; a. Participants testing positive for breath alcohol with a reading equal to or greater than .08 (the legal driving limit) or who are visibly impaired will be instructed not to drive themselves home after the appointment. If a participant needs to use a phone to call for a safe ride home, an office telephone will be made available to the participant.

Medication:

Current use or recent discontinuation (within the past 30 days at the time of Intake) of:

1. Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix, NRT);
2. Anti-psychotic medications;

3. Any medication that could compromise participant safety as determined by the Principal Investigator and/or Study Physician;

   Daily use of:

4. Opiate-containing medications for chronic pain.

Medical/Neuropsychiatric:

1. Women who are pregnant, planning a pregnancy, and/or breast feeding. All female subjects of childbearing potential will undergo a urine pregnancy test at Intake and at each scan session.
2. History of epilepsy or a seizure disorder;
3. History of stroke;
4. Self-reported brain (or CNS) or spinal tumor;
5. Self-reported history of head trauma;
6. Self-reported history or current diagnosis of psychosis.

fMRI-Related:

1. Self-reported use of pacemakers, certain metallic implants, or presence of metal in the eye as contraindicated for fMRI;
2. Self-reported history of claustrophobia;
3. Being left-handed;
4. Color blindness;
5. Weight greater than 250lbs at intake;
6. Self-reported history of gunshot wounds;
7. Any impairment preventing participants from using the response pad necessary for the computer tasks;
8. Circumstances or conditions that may interfere with magnetic resonance imaging (MRI).

General Exclusion:

1. Any medical condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator;
2. Enrollment or plans to enroll in another research study;
3. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real-time neurofeedback training group; We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. In this arm, participants will complete four sessions: an intake session and 3 neurofeedback scanning visits. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm. Secondary outcomes include changes in brain activity in areas related to craving and self-control, and self-reported craving for cigarettes.	Behavioral: Realtime biofeedback using fMRI; Real-time fMRI (rt-fMRI) allows for rapid analysis of brain activation while an individual is actively performing a task, and can be used to provide real-time neurofeedback to individuals during fMRI scanning. Using neurofeedback, individuals can learn to modulate activity in specific regions of the brain. We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. Participants will complete four sessions: an intake session and 3 scanning visits. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm.
No Intervention: No-feedback control group; We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. In the control group arm, participants will complete four sessions: an intake session and 3 scanning visits with no neurofeeback. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm. Secondary outcomes include changes in brain activity in areas related to craving and self-control, and self-reported craving for cigarettes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Lapse Paradigm	Time (sec) to first cigarette during a 50 minute monitored smoking lapse period in smoking laboratory	Study session 3 (scan day 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cue induced brain signal change	Change in mean percent signal change for Cue minus Neutral contrasts in activated brain regions	Study session 3 (scan day 3)

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 28, 2019

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (Actual): October 4, 2017

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: nicotine treatment; real time fMRI
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 828012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No