- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03421210
Effects of Smoking Environments on Brain Reactivity (CameraCue3)
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- 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)
Study Plan
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 |
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OTHER: Nicotine Replacement Therapy
Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking.
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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.
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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
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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
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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
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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".
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2 weeks after quitting smoking
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Number of Participants Experiencing Relapse
Time Frame: Weeks 1, 3, 6, and 10 weeks after quitting.
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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.
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Weeks 1, 3, 6, and 10 weeks after quitting.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00089183
- 1R01DA038442 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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