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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA038442 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Replacement Therapy | Other | Participants will receive nicotine replacement therapy for 10 weeks after quitting smoking. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine patch | Drug | 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. |
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 2 weeks after quitting smoking |
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Inclusion Criteria:
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)
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)
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| Name | Affiliation | Role |
|---|---|---|
| Francis J McClernon, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Subjects who completed the study. Those with excessive head motion or artifacts identified during QA checks were not included in analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Subjects who completed the study. Those with excessive head motion or artifacts identified during QA checks were not included in analyses. | Posted | Mean | Standard Deviation | contrast of parameter estimate (COPE) | 4 weeks |
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10 weeks after quitting smoking
Adverse events were typically identified during the administration of the Side Effects form and deemed to require followup. Other events were identified from physiological measures or by spontaneous reports during assessments.Participant's fMRI session was followed by a quit day and 10 weeks of patch use (this period included 4 follow up visits). 42 participants were scanned, 32 had usable fMRI data, 35 participants completed the entire study (all 10 weeks post quit date)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vivid Dreams | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony DeVito, MD | Duke University | 919-684-1377 | anthony.devito@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2018 | Oct 15, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 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. | Weeks 1, 3, 6, and 10 weeks after quitting. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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". | All participants with post-quit EMA data. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks after quitting smoking |
|
|
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| 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. | 42 subjects entered the quit phase of the study. | Posted | Count of Participants | Participants | Weeks 1, 3, 6, and 10 weeks after quitting. |
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| 0 |
| 42 |
| 0 |
| 42 |
| 21 |
| 42 |
| Rash at Patch site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Itching/burning at patch site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Irritability | Psychiatric disorders | Systematic Assessment |
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| Heart Burn | Gastrointestinal disorders | Systematic Assessment |
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| Nightmares | Psychiatric disorders | Systematic Assessment |
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| Elevated CESD score | Psychiatric disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Hiccups | General disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal congestion/ sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Elevated Blood Pressure | Vascular disorders | Systematic Assessment |
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| Dizzyness upon standing | Vascular disorders | Systematic Assessment |
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| Feeling Faint | Vascular disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Mouth/Throat Irritation | General disorders | Systematic Assessment |
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| Hand Numbness | Vascular disorders | Systematic Assessment |
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| Title | Measurements |
|---|
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| Week 10 |
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