Cigarette Smoking, E-Cig Use, Harm Reduction, Smoking Cessation, Tobacco Dependence, Tobacco Use Cessation
Conditions
Brief summary
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.
Interventions
OTHERJUUL
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.
Sponsors
Foundation for a Smoke Free World INC
Rose Research Center, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Has signed the ICF and is able to understand the information provided in the ICF. 2. Is 21 to 65 years of age (inclusive) at screening. 3. Smokes ≥ 10 commercially available CCs per day (no brand restrictions), for the last 12 months. 4. Expired air CO reading of at least 10 ppm as assessed at the screening session. 5. Interested in switching to an electronic cigarette. 6. Willing and able to comply with the requirements of the study. 7. Owns a smartphone with text message and data capabilities compatible with necessary surveys.
Exclusion criteria
1. 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). 2. 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. 3. Planned use of an FDA-approved smoking cessation product during the study. 4. High Blood Pressure (systolic \>150 mm Hg, diastolic \>95 mm Hg) at screening. 5. Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2. 6. 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. 7. Has received psychotherapy or behavioral treatments within 30 days of screening, or during the study. 8. Taking antidepressants or psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics). 9. Use of any of these products in the past 30 days: 1. Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, methamphetamines, or opiates); 2. Experimental (investigational) drugs that are unknown to the subject; 3. Chronic opiate use. 10. 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. 11. Pregnant or nursing (by self-report) or positive pregnancy test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of Devaluation on Switching From Cigarettes to the JUUL E-cigarette | During Weeks 9-12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Cigarette Reward With Subsequent Switching Behavior | Week 1 | 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. |
Countries
United States
Participant flow
Recruitment details
First participant was consented on 26-Aug-2019, final participant was consented on 20-Nov-2020.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | e-Cigarette Matched to Usual Brand Cigarette | e-Cigarette Unmatched to Usual Brand Cigarette | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Continuous | 46 years STANDARD_DEVIATION 9.51 | 46 years STANDARD_DEVIATION 11.82 | 46 years STANDARD_DEVIATION 10.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 21 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 19 Participants | 38 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 9 Participants | 14 Participants | 23 Participants |
| Sex: Female, Male Male | 16 Participants | 11 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 13 / 25 | 14 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: During Weeks 9-12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| e-Cigarette Matched to Usual Brand Cigarette | Effects of Devaluation on Switching From Cigarettes to the JUUL E-cigarette | 4 Participants |
| e-Cigarette Unmatched to Usual Brand Cigarette | Effects of Devaluation on Switching From Cigarettes to the JUUL E-cigarette | 4 Participants |
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.
Time frame: Week 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| e-Cigarette Matched to Usual Brand Cigarette | Changes in Cigarette Reward With Subsequent Switching Behavior | Change in Satisfaction scale of mCEQ at 1 week (V3) minus baseline (V2) | -0.8 score on a scale | Standard Deviation 1 |
| e-Cigarette Matched to Usual Brand Cigarette | Changes in Cigarette Reward With Subsequent Switching Behavior | Change in Psych Reward scale of mCEQ at 1 week (V3) minus baseline (V2) | -0.1 score on a scale | Standard Deviation 1.1 |
| e-Cigarette Unmatched to Usual Brand Cigarette | Changes in Cigarette Reward With Subsequent Switching Behavior | Change in Satisfaction scale of mCEQ at 1 week (V3) minus baseline (V2) | -0.8 score on a scale | Standard Deviation 1.2 |
| e-Cigarette Unmatched to Usual Brand Cigarette | Changes in Cigarette Reward With Subsequent Switching Behavior | Change in Psych Reward scale of mCEQ at 1 week (V3) minus baseline (V2) | -0.4 score on a scale | Standard Deviation 0.9 |