Smoking Cessation
Conditions
Keywords
smoking, smoking cessation, quitting smoking
Brief summary
A randomized, active controlled clinical trial in which a total of 216 healthy smokers will be enrolled and followed over approximately 19 weeks. The trial will evaluate the efficacy and safety of using X-22 as a smoking cessation aid. Healthy smokers who plan to quit smoking will be screened for eligibility. Subjects will be randomized in a 1:1 ratio to 1 of the 2 treatment arms: * Group 1: X-22 Cigarettes (very low nicotine) * Group 2: Active Control Cigarettes The randomization will be stratified by gender. Efficacy will be assessed by analysis of cigarette consumption using self-report diaries and measurement of exhaled carbon monoxide (CO) and cotinine concentrations. Safety will be assessed by evaluation of adverse events, physical examinations, clinical laboratory tests, and measurement of heart rate, blood pressure, and body weight at each study visit.
Interventions
DRUGX-22 Smoking Cessation Product
The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes. Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.
DRUGActive Control Cigarettes
The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional light cigarette. Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.
Sponsors
22nd Century Limited, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. 1. Subjects must be considered by the investigator to be in general good health and between 18 and 65 years of age, inclusive. 2. Subjects must have a history of smoking at least 10 cigarettes per day for at least 1 year, with less than 3 months of abstinence during the past year, and a continuous smoking history for at least 3 months prior to study entry. 3. Subjects must indicate that they plan to quit smoking within the next 3 months. 4. Subjects must have a CO measurement of ≥ 10 ppm at screening and baseline (Visit 1 and Visit 2). 5. Subjects must be willing and able to return for scheduled follow-up examinations for a total of 5 months. 6. Female subjects must have been postmenopausal for the previous 6 months or be surgically sterile, or must have a negative pregnancy test and use one of the following acceptable methods of birth control for the duration of the study and for at least 3 months prior to screening: * abstinence, meaning a total lack of sexual activity, * oral contraceptives (the pill), * contraceptive injections, * intrauterine device, * double-barrier method (diaphragm or condom plus spermicidal cream), * contraceptive patch, hormonal implant, hormonal vaginal ring, or * male partner sterilization at least 3 months prior to screening. 7. Subjects must sign and be given a copy of the written Informed Consent form. 8. Subjects must be able to read, understand and complete the questionnaires independently.
Exclusion criteria
* Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes | Weeks 7 and 9 = telephone call, Week 8 = visit 6 and Week 10 = visit 7 | The primary efficacy measurement is the number of subjects with 4 weeks of continuous abstinence from smoking cigarettes (Weeks 7-10), as assessed by subject diary and confirmed by exhaled carbon monoxide (CO), after treatment termination, at Visits 6 and 7. A responder: did not smoke and had less than 10 ppm exhaled CO. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| X-22 Smoking Cessation Product The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
X-22 Smoking Cessation Product: The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period. | 118 |
| Active Control Cigarette The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional light cigarette.
Active Control Cigarettes: The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional light cigarette.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period. | 116 |
| Total | 234 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 18 | 11 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Subject in jail | 1 | 0 |
| Overall Study | Withdrawal by Subject | 15 | 8 |
Baseline characteristics
| Characteristic | Active Control Cigarette | Total | X-22 Smoking Cessation Product |
|---|---|---|---|
| Age, Continuous | 41.8 Years STANDARD_DEVIATION 11.2 | 41.9 Years STANDARD_DEVIATION 11.1 | 42.1 Years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 59 Participants | 26 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 | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 81 Participants | 169 Participants | 88 Participants |
| Sex: Female, Male Female | 52 Participants | 106 Participants | 54 Participants |
| Sex: Female, Male Male | 64 Participants | 128 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 118 | 1 / 116 |
| other Total, other adverse events | 60 / 118 | 58 / 116 |
| serious Total, serious adverse events | 5 / 118 | 1 / 116 |
Outcome results
Primary
Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes
The primary efficacy measurement is the number of subjects with 4 weeks of continuous abstinence from smoking cigarettes (Weeks 7-10), as assessed by subject diary and confirmed by exhaled carbon monoxide (CO), after treatment termination, at Visits 6 and 7. A responder: did not smoke and had less than 10 ppm exhaled CO.
Time frame: Weeks 7 and 9 = telephone call, Week 8 = visit 6 and Week 10 = visit 7
Population: intent to treat (ITT) population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| X-22 Smoking Cessation Product | Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes | Week 8 responder | 14 Participants |
| X-22 Smoking Cessation Product | Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes | Week 10 - Exhaled CO <= 10ppm | 38 Participants |
| X-22 Smoking Cessation Product | Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes | Week 8 - Exhaled CO <= 10ppm | 32 Participants |
| X-22 Smoking Cessation Product | Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes | Week 10 responder | 16 Participants |
| X-22 Smoking Cessation Product | Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes | Week 10 - No Cigarettes Smoked per Diary (Weeks 9 and 10) | 16 Participants |
| X-22 Smoking Cessation Product | Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes | Overall Responder | 13 Participants |
| X-22 Smoking Cessation Product | Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes | Week 8 - No Cigarettes Smoked per Diary (Weeks 7 and 8) | 14 Participants |
| Active Control Cigarette | Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes | Overall Responder | 10 Participants |
| Active Control Cigarette | Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes | Week 8 - No Cigarettes Smoked per Diary (Weeks 7 and 8) | 14 Participants |
| Active Control Cigarette | Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes | Week 8 - Exhaled CO <= 10ppm | 36 Participants |
| Active Control Cigarette | Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes | Week 8 responder | 11 Participants |
| Active Control Cigarette | Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes | Week 10 - No Cigarettes Smoked per Diary (Weeks 9 and 10) | 18 Participants |
| Active Control Cigarette | Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes | Week 10 - Exhaled CO <= 10ppm | 30 Participants |
| Active Control Cigarette | Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes | Week 10 responder | 13 Participants |