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Real Time fMRI and Quitting Smoking

Primary Purpose

Nicotine Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Realtime biofeedback using fMRI
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Use Disorder focused on measuring nicotine treatment, real time fMRI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Real-time neurofeedback training group

No-feedback control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Smoking Lapse Paradigm
Time (sec) to first cigarette during a 50 minute monitored smoking lapse period in smoking laboratory

Secondary Outcome Measures

Cue induced brain signal change
Change in mean percent signal change for Cue minus Neutral contrasts in activated brain regions

Full Information

First Posted
September 26, 2017
Last Updated
April 15, 2019
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03302026
Brief Title
Real Time fMRI and Quitting Smoking
Official Title
A Proof-of-concept Study of Real-time fMRI Neurofeedback Training for Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Use Disorder
Keywords
nicotine treatment, real time fMRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
Treatment-seeking smokers complete an intake session and then be randomized to an active NFT group or a control group.
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real-time neurofeedback training group
Arm Type
Experimental
Arm Description
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.
Arm Title
No-feedback control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Realtime biofeedback using fMRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Smoking Lapse Paradigm
Description
Time (sec) to first cigarette during a 50 minute monitored smoking lapse period in smoking laboratory
Time Frame
Study session 3 (scan day 3)
Secondary Outcome Measure Information:
Title
Cue induced brain signal change
Description
Change in mean percent signal change for Cue minus Neutral contrasts in activated brain regions
Time Frame
Study session 3 (scan day 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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. Medical/Neuropsychiatric: 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. History of epilepsy or a seizure disorder; History of stroke; Self-reported brain (or CNS) or spinal tumor; Self-reported history of head trauma; Self-reported history or current diagnosis of psychosis. fMRI-Related: Self-reported use of pacemakers, certain metallic implants, or presence of metal in the eye as contraindicated for fMRI; Self-reported history of claustrophobia; Being left-handed; Color blindness; Weight greater than 250lbs at intake; Self-reported history of gunshot wounds; Any impairment preventing participants from using the response pad necessary for the computer tasks; Circumstances or conditions that may interfere with magnetic resonance imaging (MRI). General Exclusion: Any medical condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator; Enrollment or plans to enroll in another research study; Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Real Time fMRI and Quitting Smoking

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