Real Time fMRI and Quitting Smoking

NCT03302026 | Completed

• 1 other identifier: 828012
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nicotine Use Disorder

Keywords

nicotine treatment; real time fMRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cue induced brain signal change

  Study session 3 (scan day 3)

Study Arms (2)

Real-time neurofeedback training group

EXPERIMENTAL

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

No-feedback control group

NO INTERVENTION

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.

Interventions

Realtime biofeedback using fMRI BEHAVIORAL

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.

Real-time neurofeedback training group

Eligibility Criteria

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

You may qualify if:

• 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;
• Planning to live in the area for at least the next month;
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form;
• Able to communicate fluently in English (speaking, writing, and reading).

You may not qualify if:

• Smoking Behavior:
• Use of chewing tobacco or snuff or cigars;
• Current enrollment or plans to enroll in another smoking cessation program or research study in the next month;
• Current or anticipated (within the next month) use of smoking cessation medications or nicotine replacement therapy (NRT);
• A baseline carbon monoxide (CO) reading less than 10ppm.
• Alcohol/Drugs:
• Current alcohol consumption that exceeds 25 standard drinks/week;
• 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:
• Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix, NRT);
• Anti-psychotic medications;
• Any medication that could compromise participant safety as determined by the Principal Investigator and/or Study Physician;
• Daily use of:
• Opiate-containing medications for chronic pain.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Treatment-seeking smokers complete an intake session and then be randomized to an active NFT group or a control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed study will evaluate the effects of rt-fMRI neurofeedback training on the ability to resist craving for cigarettes. The study will be conducted in two phases: a technical development phase and a proof-of-concept phase focused on efficacy. The technical development phase will be completed before beginning the proof-of-concept phase. Eligible consenting treatment-seeking smokers complete an intake session and then be randomized to an active NFT group or a control group. Both groups will complete three scanning sessions, followed by a smoking resist evaluation.

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 4, 2017
• Study Start: January 2, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 28, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)