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| Name | Class |
|---|---|
| Foundation for a Smoke Free World INC | OTHER |
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This study will evaluate a reward devaluation strategy in which smokers use the JUUL e-cigarette immediately before any combustible cigarettes (CCs) are smoked. This procedure is predicted to accomplish three goals: 1) the rewarding effects of CC will be disrupted because subjects will already have attained fairly high peak nicotine concentrations immediately before smoking the cigarette. This reduces the rewarding effect of smoking, in part from receptor desensitization that occurs following nicotine exposure, which reduces the response to a subsequent dose of nicotine, and in part from satiating the drive to smoke; 2) the use of the JUUL will become associated with the same cues that elicit smoking, thereby promoting the substitution of JUUL use for CC use; and 3) ad libitum nicotine intake from the JUUL and its rewarding effects will be maximized because, unlike CC, they will be experienced after a period of nicotine deprivation. Thus, despite a lower per-puff nicotine dose relative to CC, the pharmacologic impact and reinforcing effect will be maximized. The study will evaluate two flavors (Mint and Virginia Tobacco), randomly assigned, to determine if flavor assignment (similar to the subjects' usual brand of CC or different than the subjects usual brand CC) has an effect on the success of this reconditioning procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| e-Cigarette Matched to Usual Brand Cigarette | Experimental | JUUL and cigarette flavor matched ("Mint" for menthol smokers and "Virginia Tobacco" for non-menthol smokers); |
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| e-Cigarette Unmatched to Usual Brand Cigarette | Experimental | JUUL and cigarette flavor unmatched ("Virginia Tobacco" for menthol smokers and "Mint" for non-menthol smokers). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUUL | Other | Subjects will be instructed to use the JUUL as often as they like during the 12-week product use period. They will also be instructed to use JUUL immediately before each cigarette to relieve their craving as much as possible before smoking their usual brand. The JUUL will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute JUUL for cigarettes by the end of the first week of use. |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of Devaluation on Switching From Cigarettes to the JUUL E-cigarette | Biochemically verified smoking abstinence during weeks 9-12, i.e., self-report of no smoking confirmed by an expired air CO reading of <5 ppm. | During Weeks 9-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Cigarette Reward With Subsequent Switching Behavior | Characterize changes in the two primary scales of the Cigarette Evaluation Questionnaire (mCEQ), assessing smoking satisfaction and psychological reward, over the first week of the study period. The mCEQ uses a 7-point scale (0=Not at all; 1=Very little; 2=A little; 3=Moderately; 4=A lot, 5=Quite a lot; 6=Extremely) to measure all subscales: Satisfaction, Psychological Reward, Enjoyment of Respiratory Tract Sensations, Craving Reduction, Aversion. Both subscales have the same "7-point scale" range. |
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Inclusion Criteria:
Exclusion Criteria:
Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigator or designated medical staff based on all available assessments from the screening period (e.g., safety laboratory, vital signs, physical examination, ECG, concomitant medications and medical history).
PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") at screening.
Planned use of an FDA-approved smoking cessation product during the study.
High Blood Pressure (systolic >150 mm Hg, diastolic >95 mm Hg) at screening.
Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.
Coronary heart disease, structural cardiac disease (including, but not limited to valvular heart disease or cardiac murmurs), cardiac dysrhythmias, syncope, cardiac chest pain, or history of heart attack or heart failure.
Has received psychotherapy or behavioral treatments within 30 days of screening, or during the study.
Taking antidepressants or psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics).
Use of any of these products in the past 30 days:
Use of smokeless tobacco (chewing tobacco, snuff), cigars (except for "Black & Mild" cigars or Cigarillos), pipes, hookah, e-cigarettes, nicotine replacement therapy or other smoking cessation treatments within 14 days of screening.
Pregnant or nursing (by self-report) or positive pregnancy test.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rose Research Center | Charlotte | North Carolina | 28262 | United States | ||
| Rose Research Center |
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First participant was consented on 26-Aug-2019, final participant was consented on 20-Nov-2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | e-Cigarette Matched to Usual Brand Cigarette | JUUL and cigarette flavor matched ("Mint" for menthol smokers and "Virginia Tobacco" for non-menthol smokers); JUUL: Subjects will be instructed to use the JUUL as often as they like during the 12-week product use period. They will also be instructed to use JUUL immediately before each cigarette to relieve their craving as much as possible before smoking their usual brand. The JUUL will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute JUUL for cigarettes by the end of the first week of use. |
| FG001 | e-Cigarette Unmatched to Usual Brand Cigarette | JUUL and cigarette flavor unmatched ("Virginia Tobacco" for menthol smokers and "Mint" for non-menthol smokers). JUUL: Subjects will be instructed to use the JUUL as often as they like during the 12-week product use period. They will also be instructed to use JUUL immediately before each cigarette to relieve their craving as much as possible before smoking their usual brand. The JUUL will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute JUUL for cigarettes by the end of the first week of use. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | e-Cigarette Matched to Usual Brand Cigarette | JUUL and cigarette flavor matched ("Mint" for menthol smokers and "Virginia Tobacco" for non-menthol smokers); JUUL: Subjects will be instructed to use the JUUL as often as they like during the 12-week product use period. They will also be instructed to use JUUL immediately before each cigarette to relieve their craving as much as possible before smoking their usual brand. The JUUL will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute JUUL for cigarettes by the end of the first week of use. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Effects of Devaluation on Switching From Cigarettes to the JUUL E-cigarette | Biochemically verified smoking abstinence during weeks 9-12, i.e., self-report of no smoking confirmed by an expired air CO reading of <5 ppm. | Posted | Count of Participants | Participants | During Weeks 9-12 |
|
12 weeks
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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 | e-Cigarette Matched to Usual Brand Cigarette | JUUL and cigarette flavor matched ("Mint" for menthol smokers and "Virginia Tobacco" for non-menthol smokers); JUUL: Subjects will be instructed to use the JUUL as often as they like during the 12-week product use period. They will also be instructed to use JUUL immediately before each cigarette to relieve their craving as much as possible before smoking their usual brand. The JUUL will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute JUUL for cigarettes by the end of the first week of use. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jed E. Rose | Rose Research Center | 9193282345 | jed.rose@roseresearchcenter.com |
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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 | Sep 29, 2020 | Apr 20, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D040261 | Harm Reduction |
| D000072137 | Vaping |
| D000073865 | Cigarette Smoking |
| D014029 | Tobacco Use Disorder |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012907 | Smoking |
| D000073869 | Tobacco Smoking |
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|
| Week 1 |
| Raleigh |
| North Carolina |
| 27617 |
| United States |
| Pregnancy |
|
| BG001 | e-Cigarette Unmatched to Usual Brand Cigarette | JUUL and cigarette flavor unmatched ("Virginia Tobacco" for menthol smokers and "Mint" for non-menthol smokers). JUUL: Subjects will be instructed to use the JUUL as often as they like during the 12-week product use period. They will also be instructed to use JUUL immediately before each cigarette to relieve their craving as much as possible before smoking their usual brand. The JUUL will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute JUUL for cigarettes by the end of the first week of use. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| 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 | Number | participants |
|
| OG001 | e-Cigarette Unmatched to Usual Brand Cigarette | JUUL and cigarette flavor unmatched ("Virginia Tobacco" for menthol smokers and "Mint" for non-menthol smokers). JUUL: Subjects will be instructed to use the JUUL as often as they like during the 12-week product use period. They will also be instructed to use JUUL immediately before each cigarette to relieve their craving as much as possible before smoking their usual brand. The JUUL will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute JUUL for cigarettes by the end of the first week of use. |
|
|
| Secondary | Changes in Cigarette Reward With Subsequent Switching Behavior | Characterize changes in the two primary scales of the Cigarette Evaluation Questionnaire (mCEQ), assessing smoking satisfaction and psychological reward, over the first week of the study period. The mCEQ uses a 7-point scale (0=Not at all; 1=Very little; 2=A little; 3=Moderately; 4=A lot, 5=Quite a lot; 6=Extremely) to measure all subscales: Satisfaction, Psychological Reward, Enjoyment of Respiratory Tract Sensations, Craving Reduction, Aversion. Both subscales have the same "7-point scale" range. | Posted | Mean | Standard Deviation | score on a scale | Week 1 |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 13 |
| 25 |
| EG001 | e-Cigarette Unmatched to Usual Brand Cigarette | JUUL and cigarette flavor unmatched ("Virginia Tobacco" for menthol smokers and "Mint" for non-menthol smokers). JUUL: Subjects will be instructed to use the JUUL as often as they like during the 12-week product use period. They will also be instructed to use JUUL immediately before each cigarette to relieve their craving as much as possible before smoking their usual brand. The JUUL will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute JUUL for cigarettes by the end of the first week of use. | 0 | 25 | 0 | 25 | 14 | 25 |
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Nausea | Nervous system disorders | Systematic Assessment |
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| Elevated Blood Pressure | Cardiac disorders | Systematic Assessment |
|
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| D064424 |
| Tobacco Use |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |