Real Time fMRI and Quitting Smoking

Nicotine Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302026
• Other study ID #: 828012
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: March 28, 2019

Study information

• Verified date: April 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 28, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Use Disorder
• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)