A Study to Assess Changes in Cigarette Consumption During a Switch to Very Low Nicotine Cigarettes

NCT03571724 | Completed Results

• 1 other identifier: CA24914
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the impact of switching from usual brand cigarettes to very low nicotine cigarettes on cigarette consumption, smoking behavior, and biomarkers of exposure.

Conditions

Tobacco Use

Keywords

Very Low Nicotine; Cigarette; VLN

Outcome Measures

Primary Outcomes (1)

• Cigarettes Per Day

  Primary objective is to measure a change in cigarette consumption behavior before, during and after switching from usual brand to to VLN cigarettes. Subjects will record their cigarette consumption daily in an electronic diary. The baseline data were collected for participants at Week -1, and Week -1 data are reported per post-switch Arms/Group randomization (instead of pre-switch Arms/Group assignment).All 142 randomized subjects were included in the ITT population based on product use. Out of these, 71 subjects were included in the PP Population and 71 were excluded. All excluded subjects had a ratio of \[plasma cotinine/CPD VLN\]/\[plasma cotinine/CPD baseline\] \> 0.2. It was pre-specified to exclude participants with a ratio \>0.2 as they were considered non-compliant.

  Assessed daily from Week -1 to Week 6; Week -1, Week 2, and Week 6 reported

Secondary Outcomes (20)

• Biomarkers of Exposure - Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1 Butanol (NNAL)

  -1 week, and at 2 and 6 weeks.

• Biomarkers of Exposure - Total N-Nitrosonornicotine (NNN)

  -1 week, and at 2 and 6 weeks.

• Biomarkers of Exposure - S-phenylmercapturic Acid (S-PMA)

  -1 week, and at 2 and 6 weeks.

• Biomarkers of Exposure - 3-hydroxypropylmercapturic Acid (3-HPMA)

  -1 week, and at 2 and 6 weeks.

• Biomarkers of Exposure - 1-hydroxy Pyrene(1-OHP)

  -1 week, and at 2 and 6 weeks.

Study Arms (2)

Usual Brand (UB) non-mentholated filtered cigarettes

EXPERIMENTAL

Usual Brand (UB) mentholated filtered cigarettes Usual Brand (UB) non-mentholated filtered cigarettes or to very low nicotine non-mentholated cigarettes

Other: Non-Menthol Very Low Nicotine Cigarettes; Other: Subject's UB non-mentholated filtered cigarettes

Usual Brand (UB) mentholated filtered cigarettes

EXPERIMENTAL

Subjects will be randomized to continue to smoke Usual Brand (UB) mentholated filtered cigarettes or to very low nicotine mentholated cigarettes

Other: Menthol Very Low Nicotine Cigarettes; Other: Subject's UB mentholated filtered cigarettes

Interventions

Non-Menthol Very Low Nicotine Cigarettes OTHER

King size non-menthol cigarettes containing 0.4mg nicotine /g tobacco

Usual Brand (UB) non-mentholated filtered cigarettes

Menthol Very Low Nicotine Cigarettes OTHER

King size menthol cigarettes containing 0.4mg nicotine /g tobacco

Usual Brand (UB) mentholated filtered cigarettes

Subject's UB non-mentholated filtered cigarettes OTHER

King size non-menthol cigarettes

Usual Brand (UB) non-mentholated filtered cigarettes

Subject's UB mentholated filtered cigarettes OTHER

King size menthol cigarettes

Usual Brand (UB) mentholated filtered cigarettes

Eligibility Criteria

• Age: 26 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a healthy adult male or female adult smoker, 26 to 65 years of age, inclusive, at Screening.
• Has been a smoker for at least 5 years prior to Screening. Brief periods of non smoking (e.g., up to 7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) during that time will be permitted at the discretion of the Investigator.
• Reports smoking an average of 10 or more manufactured combustible cigarettes per day at Screening.
• Usual brand (UB) of cigarette is a filtered king size cigarette (with an approximate length of 84 mm (± 3 mm)).
• Has a positive urine cotinine (≥ 500 ng/ml) at Screening.
• Has an exhaled Carbon Monoxide \> 10 ppm at Screening.
• If female, has a negative serum pregnancy test at Screening.
• A female subject of childbearing potential must have been using one of the following forms of contraception and agree to continue using it through completion of the study:
• hormonal (e.g., oral, vaginal ring, transdermal patch, implant, or injection) consistently for at least 3 months prior to Screening;
• double barrier method (e.g., condom with spermicide, diaphragm with spermicide) consistently for at least 14 days prior to Screening;
• intrauterine device for at least 3 months prior to Screening;
• Essure® or similar nonsurgical sterilization procedure at least 6 months prior to Screening
• a partner who has been vasectomized for at least 6 months prior to Screening;
• abstinence beginning at least 14 days prior to Screening and through the End of Study.
• A female subject of non childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Screening:

You may not qualify if:

• Subjects may be excluded from the study if there is evidence of any of the following criteria at Screening, start of Week -1 (first clinic visit), or during the study as noted, in the opinion of the Investigator.
• History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary (especially bronchospastic diseases and asthma), immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
• Clinically significant abnormal findings on the physical examination, medical history, ECG, or clinical laboratory results, in the opinion of the Investigator.
• Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
• An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment with prescription medication(s) within 14 days prior to Screening or first clinic visit.
• Fever (\>100.5 degrees F) at Screening or first clinic visit.
• Body mass index (BMI) greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Screening.
• History of drug or alcohol abuse or has used medical/recreational marijuana within 12 months of Screening.
• Diabetes mellitus that is not controlled by diet/exercise alone, in the opinion of the Investigator.
• Seated heart rate is lower than 40 bpm or higher than 99 bpm at Screening, unless deemed not clinically significant by the PI.
• Seated systolic blood pressure \<90 mmHg or \>150 mmHg, diastolic blood pressure \<40 mmHg or \>95 mmHg at Screening, unless deemed not clinically significant by the PI.
• Positive urine screen for drugs of abuse or alcohol at Screening or at the first clinic visit.
• Female subjects who are pregnant, lactating, or intend to become pregnant from Screening through the End of Study.
• Use of medications known to interact with cytochrome p450 2A6 (including, but not limited to, amiodarone, desipramine, isoniazid, ketoconazole, miconazole, phenobarbital, rifampin, tranylcypromine, methoxsalen) within 3 months prior to Screening and throughout the study.
• Use of inhalers to treat any medical condition within 3 months prior to Screening and throughout the study.

Sponsors & Collaborators

• 22nd Century Group, Inc.: lead
• Celerion: collaborator

Study Sites (2)

Celerion

Lincoln, Nebraska, 68502, United States

Location

High Point Clinical Trials

High Point, North Carolina, 27265, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

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

kdelaney@xxiicentury.com

716-270-1523

Study Officials

• Philip L Matthew, MD

  Celerion

  PRINCIPAL INVESTIGATOR

• Melanie Fein

  High Point Clinical Trials

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Longitudinal ambulatory switching study

Study Record Dates

• First Submitted: June 2, 2018
• First Posted: June 28, 2018
• Study Start: June 28, 2018
• Primary Completion: January 25, 2019
• Study Completion: March 8, 2019
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)