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Neural Mechanisms Associated With Risk of Smoking Relapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837510
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
This study will examine how abstinence-induced brain changes contribute to smoking cessation outcomes in treatment-seeking smokers.

Condition or disease Intervention/treatment Phase
Nicotine Addiction Behavioral: Standard smoking cessation counseling Not Applicable

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. To improve quit rates significantly, a more refined mechanistic understanding is needed. Neuroimaging can identify mechanisms underlying behavior change beyond self-report and behavioral measures. Functional magnetic resonance imaging (fMRI) studies show that brief (e.g., 24 hr.) abstinence from smoking produces working memory deficits associated with reduced neural activity in cognitive control circuits and weakened resting state functional connectivity. Neural reactivity to smoking cues also increases risk of relapse, and psychological stress can enhance neural responses to smoking cues and increase smoking intensity. This study will examine how abstinence-induced brain changes contribute to clinical outcomes in treatment-seeking smokers. Using a validated fMRI abstinence challenge paradigm, 200 treatment-seeking smokers will complete two 1-hour pre-treatment fMRI scans: after smoking satiety and after 24 hours of confirmed abstinence. The investigators will examine brain responses during performance of tasks probing working memory, cue reactivity, and stress response as well as resting state functional connectivity. Participants will then set a target quit date, receive smoking cessation counseling, and be monitored for 6 months to assess time to relapse using a validated smoking relapse protocol.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neural Mechanisms Associated With Risk of Smoking Relapse
Actual Study Start Date : May 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Standard smoking cessation counseling
Participants will receive a standard treatment program consisting of smoking cessation counseling.
Behavioral: Standard smoking cessation counseling
Participants will discuss reasons for quitting, the model of smoking as a learned habit, triggers for smoking, and trigger management; receive brief training in how to manage withdrawal symptoms and relapse prevention counseling and receive the NCI Clearing the Air self-help smoking cessation booklet. The target quit date (TQD) session will be scheduled to occur up to 2 weeks following the pre-quit session. Participants will then meet with a smoking cessation counselor for a 15 minute booster counseling session. During the first week following TQD there will be two monitoring visits to closely monitor abstinence. Weekly thereafter for four weeks, participants will attend a brief booster counseling session.




Primary Outcome Measures :
  1. Days to relapse [ Time Frame: 6 months after target quit date ]
    The primary outcome will be the number of days to relapse following the target quit date. Relapse will be confirmed using a conventional SRNT guideline criterion of either a positive biochemical verification of smoking or 7 consecutive days of smoking based on self-report (it is very unlikely that a subject would meet the latter criterion without also meeting the former, given the long half-life of cotinine). The days to relapse will be based upon time from target quit date to the first day of the relapse period. Self-reported daily smoking data will be collected using a validated timeline follow-back method. Self-reported abstinence will be biochemically verified on a weekly basis using urine cotinine (<100ng/ml) and a CO reading of ≤5PPM. Drop-outs will be considered relapsers following the last date of abstinence data provided.


Secondary Outcome Measures :
  1. Mood [ Time Frame: Target Quit Date through 6-month follow-up ]
    The Positive and Negative Affect Schedule (PANAS), a 20-item Likert-format self-report measure, will be used to assess Positive Affect (PA; 10 items, e.g., enthusiastic, strong) and Negative Affect (NA; 10 items, e.g., distressed, upset), two dominant and generally orthogonal dimensions of affect. This measure will be administered at all study visits

  2. Nicotine withdrawal [ Time Frame: Target Quit Date through 6-month follow-up ]
    The Revised Minnesota Nicotine Withdrawal Scale (MNWS-R) is a fifteen-item self-report measure where participants rate their feelings of withdrawal on a scale of 0 (none) to 4 (severe). This measure will be administered at all study visits.

  3. Smoking Urges/Craving [ Time Frame: Target Quit Date through 6-month follow-up ]
    The 10-item brief QSU-B questionnaire on smoking urges will be administered at the same time points to assess cravings to smoke. The QSU-B contains 2 subscales (anticipation of reward, relief from negative affect).

  4. Stress/Anxiety [ Time Frame: 1-2 weeks following intake session ]
    Anxiety will be measured at intake and at both fMRI scanning sessions using the State-Trait Anxiety Index, which has been used as a covariate in fMRI studies of stress response.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible participants will be:

  1. Treatment-seeking smokers between the ages of 18 and 65, reporting consumption of at least 5 cigarettes per day for at least the past 6 months;
  2. Planning to live in the area for at least the next 3 months;
  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:

Subjects who present and/or self-report with the following criteria at any point during study participation will not be eligible to participate in the study:

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 3 months;
  3. Current or anticipated (within the next 3 months) use of smoking cessation medications or nicotine replacement therapy (NRT);
  4. A baseline carbon monoxide (CO) reading less than or equal to 8ppm.

Alcohol/Drugs:

  1. Diagnosis or treatment for alcohol or drug abuse in the past two years as reported during phone screen (e.g., alcohol, opioids, cocaine, or stimulants);
  2. Current alcohol consumption that exceeds 25 standard drinks/week;
  3. 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.

  4. A positive urine drug screen for cocaine, opiates, PCP, benzodiazepines, methadone, MDMA, amphetamine, methamphetamine, tri-cyclic antidepressants and/or barbiturates at any session;

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. Anti-depressants (tricyclics, SSRI's, selective and nonselective MAOIs, Wellbutrin/Zyban);
  4. Anti-anxiety agents;
  5. Anti-panic agents;
  6. Prescription (e.g., Provigil, Ritalin) or over-the-counter stimulants;
  7. Prescription sleep aids (e.g., Ambien, Lunesta) if used more than 2x/week. If participants report use less than twice a week, they will just be asked to refrain from use during imaging portion of the study.
  8. Any medication that could compromise participant safety as determined by the Principal Investigator and/or Study Physician;

    Daily use of:

  9. 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 both fMRI scan visits (3 urine pregnancy tests in total).
  2. History of epilepsy or a seizure disorder;
  3. History of stroke;
  4. Self-reported brain or spinal tumor;
  5. Self-reported history or current diagnosis of psychosis, bipolar disorder, schizophrenia, current major depression (subjects with a history of major depression but in remission for past 6 months are eligible), or any Axis 1 disorder.

fMRI-Related:

  1. Self-reported history of head trauma;
  2. Self-reported brain (or CNS) or spinal tumor;
  3. Self-reported use of pacemakers, certain metallic implants, or presence of metal in the eye as contraindicated for fMRI;
  4. Self-reported history of claustrophobia;
  5. Being left-handed;
  6. Color blindness;
  7. Weight greater than 299lbs;
  8. Self-reported history of gunshot wounds;
  9. Any impairment preventing participants from using the response pad necessary for the cognitive testing;
  10. 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. Low or borderline intellectual functioning - determined by a score of less than 85 on the Shipley Institute of Living Scale (SILS) (administered at Intake Visit);
  3. Enrollment or plans to enroll in another research study;
  4. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837510


Contacts
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Contact: Mary Falcone, Ph.D. 215-746-3782 mfalc@mail.med.upenn.edu
Contact: Leah Bernardo, B.A. 215-746-7162 lleah@mail.med.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Falcone, Ph.D.    215-746-3782    mfalc@mail.med.upenn.edu   
Contact: Leah Bernardo, B.A.    215-746-7162    lleah@mail.med.upenn.edu   
Sub-Investigator: Caryn Lerman, Ph.D.         
Principal Investigator: James Loughead, Ph.D.         
Sub-Investigator: Rebecca Ashare, Ph.D.         
Sub-Investigator: Taki Shinohara, Ph.D.         
Sub-Investigator: John Detre, M.D.         
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: James Loughead, Ph.D. University of Pennsylvania
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02837510    
Other Study ID Numbers: 824061
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Recurrence
Behavior, Addictive
Disease Attributes
Pathologic Processes
Compulsive Behavior
Impulsive Behavior