Randomized Trial to Evaluate the Effectiveness of X-22 as a Smoking Cessation Aid

NCT01400815 | Completed Phase 2 Results

• 1 other identifier: X-22-201
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 3

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.

Conditions

Smoking Cessation

Keywords

smoking; smoking cessation; quitting smoking

Outcome Measures

Primary Outcomes (1)

• 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.

  Weeks 7 and 9 = telephone call, Week 8 = visit 6 and Week 10 = visit 7

Study Arms (2)

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.

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.

Drug: Active Control Cigarettes

Interventions

X-22 Smoking Cessation Product DRUG

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.

X-22 Smoking Cessation Product

Active Control Cigarettes DRUG

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.

Active Control Cigarette

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• 22nd Century Limited, LLC: lead

Study Sites (3)

Benchmark Research Sacramento

Sacramento, California, 95816, United States

Location

Benchmark Research New Orleans

Metairie, Louisiana, 70006, United States

Location

Benchmark Research Austin

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Karen Delaney
• Organization: 22nd Century Group, Inc.

kdelaney@xxiicentury.com

716-270-1523

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 22, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 19, 2021
• Results First Posted: November 19, 2021

Record last verified: 2021-10

Locations

US (3)