Smoking CessationPhase 2NCT01400815
Randomized Trial to Evaluate the Effectiveness of X-22 as a Smoking Cessation Aid
A Phase 2 study testing X-22 Smoking Cessation Product in people with Smoking Cessation, run by 22nd Century Limited, LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- X-22 Smoking Cessation Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2011to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
- Subjects must be considered by the investigator to be in general good health and between 18 and 65 years of age, inclusive.
- 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.
- Subjects must indicate that they plan to quit smoking within the next 3 months.
- Subjects must have a CO measurement of ≥ 10 ppm at screening and baseline (Visit 1 and Visit 2).
- Subjects must be willing and able to return for scheduled follow-up examinations for a total of 5 months.
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- 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.
Who cannot join
- Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- Subjects who have a household member who is already enrolled in this trial.
- Subjects who have attempted to quit smoking using one or more FDA-approved smoking cessation products (eg, nicotine replacement therapy [NRT] including nicotine gum, nicotine lozenges, nicotine patches, nicotine nasal spray, or nicotine inhaler; Zyban [bupropion]; or Chantix [varenicline]) for longer than 1 week in the past 3 months.
- Subjects who have been enrolled in another structured smoking cessation program (e.g., behavioral modification, hypnosis, acupuncture, or other alternative therapies) in the last 30 days.
- Subjects who have been in another smoking cessation trial in the past 6 months.
- Subjects who regularly use (greater than once per month) tobacco-based products other than cigarettes (eg, chew, snuff, snus, shisha, etc.).
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- Subjects with a history of coronary artery disease, myocardial infarction, stroke, chronic obstructive pulmonary disease, or other significant pulmonary diseases. Controlled hypertensive subjects and mild asthmatics whose disease is controlled only with an as-needed inhaled beta agonist are acceptable.
- Subjects with a history of cancer within the past 60 months other than basal cell carcinoma.
- Subjects with a history of thromboembolic disease or taking warfin or any other anticoagulant, or anti-platelet drug such as clopidogrel (Plavix®) or pentoxifylline (Trental®). Low dose aspirin therapy is acceptable.
- Subjects with screening laboratory abnormalities that are considered by the investigator to be clinically significant.
- Subjects with a body mass index (BMI) >35.
- Subjects with poorly controlled diabetes or insulin-dependent diabetes.
- Subjects with other known serious pathophysiology or topical or systemic disorders of any kind that would confound the results of the study.
- Subjects with screening ECG abnormalities that are considered by the investigator to be clinically significant.
- Subjects who have used any illegal drug in the past 3 months.
- Subjects who have a positive urine drug screening result.
- Subjects who are pregnant or lactating, or who plan to become pregnant during the course of the study.
- Subjects participating in any other clinical trial of an investigational drug or device during the time of this clinical investigation or within 30 days prior to Screening visit.
- Subjects taking anti-depressants, anti-psychotics, clonidine, or any of the classes of drugs listed in the RapidCHECK® 12 Panel in the last 60 days (see Section 12.1.1).
- Subjects with systolic blood pressure over 140 mmHg and/or diastolic blood pressure over 90 mmHg.
- Subjects consuming an average of 3 or more drinks of alcohol per day.
- Subjects consuming greater than an average of 2 packs of cigarettes per day.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Benchmark Research Austin
Austin, Texas, 78705
Benchmark Research New Orleans
Metairie, Louisiana, 70006
Benchmark Research Sacramento
Sacramento, California, 95816
About this study
Official title: A Prospective, Double-blind, Randomized, Active Controlled, Parallel Group, Multicenter Phase II Clinical Trial to Evaluate the Effectiveness of X-22 as a Smoking Cessation Aid
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.
Read more
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.
- Conditions
- Smoking Cessation
- Being tested
- X-22 Smoking Cessation Product, Active Control Cigarettes
- Keywords
- smoking, smoking cessation, quitting smoking
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-22 Smoking Cessation ProductDrug
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.
Active Control CigarettesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| X-22 Smoking Cessation Product | Experimental | The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes. Receives: Drug: X-22 Smoking Cessation Product |
| Active Control Cigarette | Active comparator | 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. Receives: Drug: Active Control Cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 7 and 9 = telephone call, Week 8 = visit 6 and Week 10 = visit 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- 22nd Century Limited, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400815
- Sponsor's protocol ID
- X-22-201
- Status last verified
- Oct 2021
- First submitted
- 19 Jul 2011
- Last updated
- 19 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blind, Randomized, Active Controlled, Parallel Group, Multicenter Phase II Clinical Trial to Evaluate the Effectiveness of X-22 as a Smoking Cessation Aid
- ClinicalTrials.gov ID
- NCT01400815
- Acronym / sponsor ID
- X-22-201
- Conditions
- Smoking Cessation
- Keywords
- smoking, smoking cessation, quitting smoking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- 22nd Century Limited, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2011 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Posted 19 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| X-22 Smoking Cessation Product | Experimental | Drug: X-22 Smoking Cessation ProductThe X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes. |
| Active Control Cigarette | Active comparator | Drug: Active Control CigarettesThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
- abstinence, meaning a total lack of sexual activity,
- oral contraceptives ("the pill"),
- contraceptive injections,
- intrauterine device,
Key exclusion criteria (22 listed)
- Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X-22 Smoking Cessation ProductThe 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. | Drug | X-22 Smoking Cessation Product |
| Active Control CigarettesThe 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. | Drug | Active Control Cigarette |
Primary outcome
Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing X-22 Smoking Cessation Product in people with Smoking Cessation, run by 22nd Century Limited, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes (time frame: Weeks 7 and 9 = telephone call, Week 8 = visit 6 and Week 10 = visit 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.