Cigarette Smoking
Conditions
Brief 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.
Interventions
DRUGNicotine patch
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.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Signal Change in Functional Magnetic Resonance Imaging (fMRI) Contrast of Parameter Estimate (COPE) Between Personal Environment Pictures Relative to Non-Personal Environment Pictures | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Quit Craving as Measured by (Ecological Momentary Assessment) EMA Questionnaire | 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. |
| Number of Participants Experiencing Relapse | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nicotine Replacement Therapy Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking.
Nicotine patch: 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. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Nicotine Replacement Therapy |
|---|---|
| Age, Continuous | 39.8 years STANDARD_DEVIATION 11.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 32 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 21 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
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
Population: Subjects who completed the study. Those with excessive head motion or artifacts identified during QA checks were not included in analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 Pictures | 0.0598 contrast of parameter estimate (COPE) | Standard Deviation 0.09454 |
Comparison: Differences in brain activation in response to personal smoking versus standard smoking cues were examined.p-value: 0.001t-test, 1 sided
Secondary
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.
Population: 42 subjects entered the quit phase of the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nicotine Replacement Therapy | Number of Participants Experiencing Relapse | Week 1 | 16 Participants |
| Nicotine Replacement Therapy | Number of Participants Experiencing Relapse | Week 3 | 9 Participants |
| Nicotine Replacement Therapy | Number of Participants Experiencing Relapse | Week 6 | 3 Participants |
| Nicotine Replacement Therapy | Number of Participants Experiencing Relapse | Week 10 | 0 Participants |
Secondary
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
Population: All participants with post-quit EMA data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Replacement Therapy | Post-Quit Craving as Measured by (Ecological Momentary Assessment) EMA Questionnaire | 2.49 score on a scale | Standard Deviation 1.03 |