Cigarette SmokingPhase 4CameraCue3NCT03421210
Effects of Smoking Environments on Brain Reactivity
A Phase 4 study testing Nicotine patch in people with Cigarette Smoking, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Nicotine patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2018to 23 Dec 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- generally healthy [(i.e. ambulatory, not currently sick)]
- between the ages of 18 and 65
- smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year
- an expired carbon monoxide (CO) concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine >1000 ng/mL (NicAlert = 6).
- interest in quitting smoking within the timeframe of the experiment.
- ability to identify 4 personal smoking and 4 personal non-smoking places.
- right handed as measured by a three-item scale used in our laboratory
- own a smartphone
Who cannot join
- immediate or no desire to quit smoking;
- inability to attend all required experimental sessions;
- use of other tobacco products or e-cigarettes more than 9 days in the past 30 days;
- current alcohol or drug abuse;
- positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and Phencyclidine(PCP)
- marijuana will be tested for but will not be exclusionary;
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- participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded;
- participants failing the toxicology screen will be allowed to re-screen once;
- current use of nicotine replacement therapy or other smoking cessation treatment;
- screening systolic BP greater than 140 (participants failing for blood pressure will be allowed to rescreen once)
- screening diastolic BP greater than 90 (participants failing for blood pressure will be allowed to rescreen once)
- screening heart rate greater than 100 (participants failing for heart rate will be allowed to rescreen once)
- presence of conditions contraindicated for nicotine replacement therapy (e.g., skin allergies)
- 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)
- medical condition that may contraindicate participation in the opinion of the investigator and study physician.
- current major psychiatric disease such as schizophrenia or schizoaffective disorder
- currently pregnant, breast feeding or likely to become pregnant;
- a quit attempt resulting in greater than 3 days of abstinence in the past 30 days
- presence of conditions that would make MRI unsafe (e.g., pacemaker)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
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.
- Conditions
- Cigarette Smoking
- Being tested
- Nicotine patch
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Replacement Therapy | Other | Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking. Receives: Drug: Nicotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
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".
Measured: 2 weeks after quitting smoking
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.
Measured: Weeks 1, 3, 6, and 10 weeks after quitting.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start5 Mar 2018
- Primary completion16 Oct 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Francis J McClernon, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421210
- Sponsor's protocol ID
- Pro00089183
- Other IDs
- 1R01DA038442
- Acronym
- CameraCue3
- Status last verified
- Dec 2020
- First submitted
- 22 Jan 2018
- Last updated
- 19 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Smoking Environments on Brain Reactivity
- ClinicalTrials.gov ID
- NCT03421210
- Acronym / sponsor ID
- CameraCue3 / Pro00089183
- Conditions
- Cigarette Smoking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 22 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nicotine Replacement Therapy | Other | Drug: Nicotine patchParticipants will receive nicotine replacement therapy for 10 weeks after quitting smoking. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- generally healthy [(i.e. ambulatory, not currently sick)]
- between the ages of 18 and 65
- smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year
- an expired carbon monoxide (CO) concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine >1000 ng/mL (NicAlert = 6).
- interest in quitting smoking within the timeframe of the experiment.
Key exclusion criteria (19 listed)
- immediate or no desire to quit smoking;
- inability to attend all required experimental sessions;
- use of other tobacco products or e-cigarettes more than 9 days in the past 30 days;
- current alcohol or drug abuse;
- positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and Phencyclidine(PCP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine patchParticipants 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. | Drug | Nicotine Replacement Therapy |
Primary outcome
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.
2 secondary outcomes
Post-Quit Craving as Measured by (Ecological Momentary Assessment) EMA Questionnaire
Time frame: 2 weeks after quitting smoking
Number of Participants Experiencing Relapse
Time frame: Weeks 1, 3, 6, and 10 weeks after quitting.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis J McClernon, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine patch in people with Cigarette Smoking, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.