Effects of Smoking Environments on Brain Reactivity (CameraCue3)

December 22, 2020 updated by: Duke University
The goal of this study is to evaluate correlations between brain reactivity (as assessed via functional magnetic resonance imaging (fMRI) following 24-h abstinence) and the amount of smoking in a specific location. The investigators will use ecological momentary assessment (EMA) to ask smokers to rate their exposure to, and smoking in, specific personal smoking environment cues (PSEs) over the course of 2 weeks before quitting smoking and 2 weeks after quitting smoking. The investigators propose to identify 48 regular cigarette smokers who will complete 8 visits (1 screening visit, 1 training visit, 1 camera turn-in visit, 1 fMRI session and 4 post-quit medication check sessions). Multiple methods will be used to test hypotheses about brain functioning during cue-reactivity (CR). The investigators will examine correlation between brain responses to smoking environments (minus non-smoking environments) and smoking cessation outcomes (i.e. days to lapse, days to relapse). Our EMA+Global Positioning System (GPS) analysis will primarily focus on locations where smokers smoke before and after quitting smoking. The investigators will evaluate whether EMA-assessed smoking intensity values are correlated with brain responses to these personal smoking environments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. generally healthy [(i.e. ambulatory, not currently sick)]
  2. between the ages of 18 and 65
  3. smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year
  4. an expired carbon monoxide (CO) concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine >1000 ng/mL (NicAlert = 6).
  5. interest in quitting smoking within the timeframe of the experiment.
  6. ability to identify 4 personal smoking and 4 personal non-smoking places.
  7. right handed as measured by a three-item scale used in our laboratory
  8. own a smartphone

Exclusion Criteria:

  1. immediate or no desire to quit smoking;
  2. inability to attend all required experimental sessions;
  3. use of other tobacco products or e-cigarettes more than 9 days in the past 30 days;
  4. current alcohol or drug abuse;
  5. positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and Phencyclidine(PCP)

    1. marijuana will be tested for but will not be exclusionary;
    2. participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded;
    3. participants failing the toxicology screen will be allowed to re-screen once;
  6. current use of nicotine replacement therapy or other smoking cessation treatment;
  7. screening systolic BP greater than 140 (participants failing for blood pressure will be allowed to rescreen once)
  8. screening diastolic BP greater than 90 (participants failing for blood pressure will be allowed to rescreen once)
  9. screening heart rate greater than 100 (participants failing for heart rate will be allowed to rescreen once)
  10. presence of conditions contraindicated for nicotine replacement therapy (e.g., skin allergies)
  11. report of significant health problems including but not restricted to (e.g. chronic hypertension, emphysema, seizure disorder, history of significant heart problems, heart disease, heart attack in the past 90 days, irregular heartbeat)
  12. medical condition that may contraindicate participation in the opinion of the investigator and study physician.
  13. current major psychiatric disease such as schizophrenia or schizoaffective disorder
  14. currently pregnant, breast feeding or likely to become pregnant;
  15. a quit attempt resulting in greater than 3 days of abstinence in the past 30 days
  16. presence of conditions that would make MRI unsafe (e.g., pacemaker)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Nicotine Replacement Therapy
Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking.
Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal Change in Functional Magnetic Resonance Imaging (fMRI) Contrast of Parameter Estimate (COPE) Between Personal Environment Pictures Relative to Non-Personal Environment Pictures
Time Frame: 4 weeks

Using fMRI the investigators examined brain function during cue-reactivity. During the scan, participants viewed pictures of personal and non-personal environments.

Contrast of parameter estimate (COPE) values for the difference between personal smoking environment pictures and non-personal smoking environment pictures were extracted from anatomically defined brain regions using FSL's featquery for analysis.

4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Quit Craving as Measured by (Ecological Momentary Assessment) EMA Questionnaire
Time Frame: 2 weeks after quitting smoking
EMA will be used to evaluate craving daily for 2 weeks after quitting. Subjects will rate their craving on a single item (How strong is your current urge to smoke?) using a scale from 1 "very slightly or not at all" to 5 "extremely".
2 weeks after quitting smoking
Number of Participants Experiencing Relapse
Time Frame: Weeks 1, 3, 6, and 10 weeks after quitting.
Relapse defined as 7 consecutive days smoking at least 1 cigarette per day. Individuals lost to contact are presumed to have relapsed following their last visit.
Weeks 1, 3, 6, and 10 weeks after quitting.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 5, 2018

Primary Completion (ACTUAL)

October 16, 2019

Study Completion (ACTUAL)

December 23, 2019

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

January 29, 2018

First Posted (ACTUAL)

February 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2021

Last Update Submitted That Met QC Criteria

December 22, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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