ClinicalTrials.gg
CompletedNCT03421210CameraCue3Updated Jan 19, 2021Results posted

Effects of Smoking Environments on Brain Reactivity

A Phase 4 interventional study of Nicotine patch in Cigarette Smoking, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-19.

Sponsored by Duke University · Phase 4, Interventional, and Basic science

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Phase
Phase 4
Study type
Interventional
Enrollment
88
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 11 studies testing Nicotine Patch in Cigarette Smoking — 2 open to participants now, 3 under way, 2 of them phase 3. Nicotine Patch · Cigarette Smoking.

Enrollment
8th of 11
88 · median 97
Started
2018
with 2 others
Phase 4
2 of 11
1 open now
Registered
4th of 11
by date
Lead sponsor
5 of 11
Duke University

Among the 11 studies testing Nicotine Patch in Cigarette Smoking, this one is the 8th largest by enrollment, is one of 3 that started in 2018, is one of 2 in phase 4, and was the 4th registered.

Cigarette Smoking

475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.

Browse Cigarette Smoking studies →

Open to participants now

2 of the 11 studies testing Nicotine Patch in Cigarette Smoking are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

About Nicotine Patch

Nicotine Patch: first FDA approval 1991 (NICODERM CQ). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 61 Cigarette Smoking studies recruiting now, 38 (62%) set no upper age limit and 17 (28%) stop at 75 or younger; 1 takes children under 18; 32 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies testing Nicotine Patch in Cigarette Smoking, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Cigarette Smoking

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04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
88 participants (actual)

Study arms

  • Other
    Nicotine Replacement Therapy

    Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking.

    Drug: Nicotine patch

Interventions

  • 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.

06

What researchers measure

Primary outcomes

  1. Signal Change in Functional Magnetic Resonance Imaging (fMRI) Contrast of Parameter Estimate (COPE) Between Personal Environment Pictures Relative to Non-Personal Environment Pictures

    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.

    Time frame: 4 weeks

Secondary outcomes

  1. Post-Quit Craving as Measured by (Ecological Momentary Assessment) EMA Questionnaire

    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".

    Time frame: 2 weeks after quitting smoking

  2. Number of Participants Experiencing Relapse

    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.

    Time frame: Weeks 1, 3, 6, and 10 weeks after quitting.

07

Results

Posted Dec 22, 2020

Participant flow

Participant flow — Overall Study
MilestoneNicotine Replacement Therapy
Started88
Received functional magnetic resonance imaging (fmri)42
Completed35
Not completed53

Outcome measures

PrimarySignal Change in Functional Magnetic Resonance Imaging (fMRI) Contrast of Parameter Estimate (COPE) Between Personal Environment Pictures Relative to Non-Personal Environment Pictures

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.

Time frame:
4 weeks
Reported as:
Mean · contrast of parameter estimate (COPE)
Signal Change in Functional Magnetic Resonance Imaging (fMRI) Contrast of Parameter Estimate (COPE) Between Personal Environment Pictures Relative to Non-Personal Environment Pictures
contrast of parameter estimate (COPE)Nicotine Replacement Therapy
Signal Change in Functional Magnetic Resonance Imaging (fMRI) Contrast of Parameter Estimate (COPE) Between Personal Environment Pictures Relative to Non-Personal Environment Pictures0.0598 ± 0.09454
Statistical analysis
  • Nicotine Replacement Therapy · t-test, 1 sided · p = 0.001
SecondaryPost-Quit Craving as Measured by (Ecological Momentary Assessment) EMA Questionnaire

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".

Time frame:
2 weeks after quitting smoking
Reported as:
Mean · score on a scale
Post-Quit Craving as Measured by (Ecological Momentary Assessment) EMA Questionnaire
score on a scaleNicotine Replacement Therapy
Post-Quit Craving as Measured by (Ecological Momentary Assessment) EMA Questionnaire2.49 ± 1.03
SecondaryNumber of Participants Experiencing Relapse

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.

Time frame:
Weeks 1, 3, 6, and 10 weeks after quitting.
Reported as:
Count of participants · Participants
Number of Participants Experiencing Relapse
ParticipantsNicotine Replacement Therapy
Week 116
Week 39
Week 63
Week 100

Adverse events

Collected over 10 weeks after quitting smoking. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nicotine Replacement Therapy0/42 (0%)0/42 (0%)21/42 (50%)
Most frequent other events
Showing 10 of 20
Most frequent other events
EventNicotine Replacement Therapy
Itching/burning at patch siteSkin and subcutaneous tissue disorders8/42
IrritabilityPsychiatric disorders8/42
Elevated CESD scorePsychiatric disorders7/42
Vivid DreamsPsychiatric disorders5/42
CoughingRespiratory, thoracic and mediastinal disorders5/42
Rash at Patch siteSkin and subcutaneous tissue disorders4/42
HeadacheNervous system disorders3/42
InsomniaPsychiatric disorders3/42
Heart BurnGastrointestinal disorders2/42
NightmaresPsychiatric disorders2/42

Baseline characteristics

Subjects who completed the study. Those with excessive head motion or artifacts identified during QA checks were not included in analyses.

Age, Continuous
Age, Continuous(years)Nicotine Replacement Therapy
Mean39.8 ± 11.59
Sex: Female, Male
Sex: Female, Male(Participants)Nicotine Replacement Therapy
Female14
Male18
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Nicotine Replacement Therapy
Hispanic or Latino4
Not Hispanic or Latino24
Unknown or Not Reported4
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Nicotine Replacement Therapy
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American15
White13
More than one race4
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Nicotine Replacement Therapy
United States32
08

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27705, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Oct 2019, 19 months.

Results were first posted in Dec 2020, 1 year 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2018
First posted
Feb 5, 2018
StartActual
Mar 5, 2018
Primary completionActual
Oct 16, 2019
CompletionActual
Dec 23, 2019
Results first posted
Dec 22, 2020
Last update
Jan 19, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03421210
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Feb 5, 2018
Start date
Mar 5, 2018
Primary completion
Oct 16, 2019
Completion
Dec 23, 2019
Results posted
Dec 22, 2020
Last update
Jan 19, 2021

Study contacts

Francis J McClernon, Ph.D.
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Nicotine Patch

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