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

22nd Century Limited, LLC3 sites in 1 country234 target enrollmentJuly 2011

ConditionsSmoking Cessation

InterventionsActive Control Cigarettes X-22 Smoking Cessation Product

DrugsX-22 Smoking Cessation Product Active Control Cigarettes

Overview

Phase: Phase 2
Intervention: Active Control Cigarettes
Conditions: Smoking Cessation
Sponsor: 22nd Century Limited, LLC
Enrollment: 234
Locations: 3
Primary Endpoint: Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

December 2012

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

22nd Century Limited, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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,

Exclusion Criteria

•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.).
•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.

Arms & Interventions

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.

Intervention: Active Control 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.

Intervention: X-22 Smoking Cessation Product

Outcomes

Primary Outcomes

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.