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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA037753 | 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 central objective of the project is to evaluate the effect of incorporating smoking related contexts into very low nicotine content (VLNC) cigarette extinction trials on clinically relevant, smoking-related outcomes. Adult smokers interested in quitting smoking (N=80) will be interviewed and trained to take pictures where they smoke cigarettes. Following taking these pictures, participants will then be switched to smoke VLNCs while wearing a 21 mg/d nicotine patch (EXT) for three weeks. During this 3-week treatment period, half of the sample (n=40) will be randomly assigned to undergo six, 60-minute sessions of multiple context extinction (MCE+) during which they will view smoking-related environments and smoke their assigned cigarettes. The remaining 40 participants will undergo control MCE (exposure to nature environments; MCE-) and smoke their assigned cigarettes. At the end of the three weeks, participants will quit smoking and continue to wear the nicotine patch while being followed during a 10-week abstinence period. Participants will also complete a follow-up phone call 6 months after their quit day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCE+ | Experimental | Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks. |
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| MCE- (Control) | Other | Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Patch | Drug | Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking <10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked <10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fagerstrom Test of Nicotine Dependence Score | Effects of MCE+ (vs. MCE-) on pre-quit nicotine dependence. The score of the questionnaire ranges in value from 0 (not at all dependent) to 10 (highly dependent). | baseline - week 6 |
| Number of Participants Who Met Relapse Criteria | Effects of MCE+ (vs. MCE-) on smoking cessation outcomes. Relapse is defined as 7 consecutive days of smoking. Outcome reported as number of participants who met relapse definition. | week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Number of Usual Brand Cigarettes Smoked (EXT Engagement) | Compliance with smoking VLNCs. Reduction in usual brand (UB) cigarette use over the treatment period will be calculated for each group. Average usual brand cigarettes per day was calculated using the average number for the first 5 days of treatment (week 1) and the average number for the last 5 days of treatment (week 6). Values were calculated as number smoked at W1 minus the number smoked at W6. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis J McClernon, Ph.D | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Medical Center | Durham | North Carolina | 27705 | United States |
Eighty-seven participants were enrolled and assessed for eligibility. Thirty-eight of those did not meet inclusion criteria (n=29), or withdrew (n=7) or were lost to contact (n=2) prior to baseline. Forty-nine participants completed the baseline cue-reactivity session and 34 returned for their randomization visit.
This study enrolled adult daily smokers from the Raleigh-Durham region in North Carolina who reported interest in quitting smoking
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| ID | Title | Description |
|---|---|---|
| FG000 | MCE+ | Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks. |
| FG001 | MCE- (Control) | Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | MCE+ | Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks. |
| 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 | Change in Fagerstrom Test of Nicotine Dependence Score | Effects of MCE+ (vs. MCE-) on pre-quit nicotine dependence. The score of the questionnaire ranges in value from 0 (not at all dependent) to 10 (highly dependent). | Number analyzed represents all participants who completed treatment. | Posted | Mean | Standard Deviation | score on a scale | baseline - week 6 |
|
Adverse events were collected at each study visit during participation (approximately 16 weeks).
Adverse events were typically identified during the administration of the 'Health Changes Questionnaire' and 'Respiratory Health Questionnaire', and in some cases during the administration of the 'Center for Epidemiologic Studies Depression (CESD) Scale'. Other events were identified from physiological measures or by spontaneous reports during assessments.
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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 | MCE+ | Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks. Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking <10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked <10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks. SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prio |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypertension | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergies | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. F. Joseph McClernon | Duke University | 9196682963 | joseph.mcclernon@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 | Apr 18, 2016 | Aug 17, 2018 | 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 |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| SPECTRUM Nicotine Research Cigarettes (0.07 mg) | Drug | For 3 weeks prior to their quit day, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand. |
|
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| MCE+ | Behavioral | During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. |
|
| MCE- | Behavioral | During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. |
|
| week 1, week 6 |
| Change in Number of Cigarettes Smoked Per Day (EXT Response) | Reduction in total cigarette use over the treatment period will be calculated for each group. Average cigarettes per day was calculated using the average number for the 5 days leading up to week 3 and the average number for the 5 days leading up to week 6. Values were calculated as number smoked at W3 minus the number smoked at W6. Positive values represent a decrease in smoking behavior. | week 3, week 6 |
| Change in Craving Score During MCE Task (MCE Response) | Craving score across MCE sessions. Scores range from 0 (no craving) to 100 (extreme craving) | week 3, week 4, week 5 |
| Change in Post-quit Cue-reactivity | Difference in craving responses. Craving at each time point was measured on a scale from 0 (no craving) to 100 (strong craving). Value reported represents difference in baseline - week 6. | baseline ,week 6 |
| BG001 | MCE- (Control) | Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks. |
| BG002 | Total | Total of all reporting groups |
| 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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| Cigarettes per day | Mean | Standard Deviation | cigarettes per day |
|
| Fagerstrom Test for Nicotine Dependence (FTND) score | The survey used is the Fagerstrom Test for Nicotine Dependence which provides an assessment of the individual's nicotine dependence. The scale has a range of 0 to 10 where higher numbers are associated with higher levels of dependence. | Mean | Standard Deviation | units on a scale |
|
| OG001 | MCE- (Control) | Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks. Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking <10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked <10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks. SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prior to thei |
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|
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| Primary | Number of Participants Who Met Relapse Criteria | Effects of MCE+ (vs. MCE-) on smoking cessation outcomes. Relapse is defined as 7 consecutive days of smoking. Outcome reported as number of participants who met relapse definition. | All participants randomized to treatment, and completing at least one treatment session | Posted | Count of Participants | Participants | week 16 |
|
|
|
| Secondary | Change From Baseline in Number of Usual Brand Cigarettes Smoked (EXT Engagement) | Compliance with smoking VLNCs. Reduction in usual brand (UB) cigarette use over the treatment period will be calculated for each group. Average usual brand cigarettes per day was calculated using the average number for the first 5 days of treatment (week 1) and the average number for the last 5 days of treatment (week 6). Values were calculated as number smoked at W1 minus the number smoked at W6. | Number in each group represents the number of participants who completed the pretreatment phase. | Posted | Mean | Standard Deviation | mean difference in UB cigarettes smoked | week 1, week 6 |
|
|
|
| Secondary | Change in Number of Cigarettes Smoked Per Day (EXT Response) | Reduction in total cigarette use over the treatment period will be calculated for each group. Average cigarettes per day was calculated using the average number for the 5 days leading up to week 3 and the average number for the 5 days leading up to week 6. Values were calculated as number smoked at W3 minus the number smoked at W6. Positive values represent a decrease in smoking behavior. | represents all participants who completed both week 3 and week 6 assessments | Posted | Mean | Standard Deviation | mean difference in cigarettes smoked | week 3, week 6 |
|
|
|
| Secondary | Change in Craving Score During MCE Task (MCE Response) | Craving score across MCE sessions. Scores range from 0 (no craving) to 100 (extreme craving) | Posted | Mean | Standard Deviation | score on a scale | week 3, week 4, week 5 |
|
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| Secondary | Change in Post-quit Cue-reactivity | Difference in craving responses. Craving at each time point was measured on a scale from 0 (no craving) to 100 (strong craving). Value reported represents difference in baseline - week 6. | The number of participants analyzed represents those who completed the entire pretreatment phase in each group. | Posted | Mean | Standard Deviation | units on a scale | baseline ,week 6 |
|
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|
| 0 |
| 17 |
| 1 |
| 17 |
| 14 |
| 17 |
| EG001 | MCE- (Control) | Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks. Nicotine Patch: Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking <10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked <10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks. SPECTRUM Nicotine Research Cigarettes (0.07 mg): For 3 weeks prior to thei | 0 | 17 | 0 | 17 | 16 | 17 |
| Body aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| bone fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| constipation | Gastrointestinal disorders | Systematic Assessment |
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| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| GERD | Gastrointestinal disorders | Systematic Assessment |
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| Headache, Migraine | Nervous system disorders | Systematic Assessment |
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| Headache, Non-migraine | Nervous system disorders | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Irritability | General disorders | Systematic Assessment |
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| Mania | Psychiatric disorders | Systematic Assessment |
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| Menstrual cramps | Reproductive system and breast disorders | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal sinus drainage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Nightmare | Psychiatric disorders | Systematic Assessment |
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| Pain, Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain, Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain, other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| tachycardia | Cardiac disorders | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | Systematic Assessment |
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| depressed mood | Psychiatric disorders | Systematic Assessment |
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| Ear Problem/Infection | Infections and infestations | Systematic Assessment |
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| Edema | General disorders | Systematic Assessment |
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| Dental, Teeth | Nervous system disorders | Systematic Assessment |
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| Pain, GI (abdominal) | Gastrointestinal disorders | Systematic Assessment |
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| Skin Issues, NOS | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Numbness/Tingling | Nervous system disorders | Systematic Assessment |
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| Vivid Dreams | General disorders | Systematic Assessment |
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| Tonsilitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Stress | Social circumstances | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Restlessness | Psychiatric disorders | Systematic Assessment |
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| Patch, Itching or burning at patch site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Patch, Rash at patch site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Increase in Phlegm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Mouth/throat irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bacterial Infection | Renal and urinary disorders | Systematic Assessment |
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Week 5 average |
|