BRP1802 Smoking Abstinence Study

NCT04979013 | Completed

• 1 other identifier: BRP1802
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center study designed to evaluate changes in short-term biomarkers of potential harm (BoPH) in healthy adult cigarette smokers of two age groups (Group A: 24-34 years; Group B: 35-60 years) during 14 days of smoking abstinence.

Conditions

Smoking; Smoking Cessation; Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Urinary Arachidonic Acid (AA) Metabolites 2,3-dinor-thromboxane B2 (TxM) and leukotriene E4 (LTE4)

  Change in Urinary Arachidonic Acid (AA) Metabolites TxM and LTE4

  14 days

Secondary Outcomes (11)

• Urinary AA metabolites TxM and LTE4

  7 days

• Additional AA metabolites

  14 days

• Biomarkers of Exposure in Urine: Nicotine equivalents and CEMA

  14 days

• Biomarkers of Exposure in Urine: TSNAs

  14 days

• Biomarkers of Exposure in Blood: Carboxyhemoglobin

  14 days

Study Arms (1)

Smoking Abstinence

EXPERIMENTAL

14-day Smoking Abstinence

Other: Smoking Abstinence

Interventions

Smoking Abstinence OTHER

Smokers will be switched to smoking abstinence for 14 days

Smoking Abstinence

Eligibility Criteria

• Age: 24 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
• Generally healthy male or female adults, 24 to 60 years of age, inclusive, at the time of consent.
• Able to safely perform the required study procedures, as determined by the Investigator.
• Exhaled carbon monoxide (ECO) level is ≥ 10 ppm and ≤ 100 ppm at Screening and Day -2.
• Positive urine cotinine test at Screening and Day -2.
• Smokes only combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length.
• Agrees to smoke same Usual Brand (UB) cigarette on Days -2 and -1. UB cigarette is defined as the cigarette brand style currently smoked most frequently by the subject.
• Smokes 10-20 combustible filtered cigarettes per day and inhales the smoke, and has smoked for at least 5 years prior to Screening. Brief periods of abstinence due to illness, quit attempt (30 days prior to Enrollment), or clinical study participation (30 days prior to Enrollment) will be allowed at the discretion of the Investigator. Occasional usage of other tobacco or nicotine containing products may be allowed at the discretion of the Sponsor.
• Willing to abstain from smoking during the study's abstinence period.
• Females must be willing to use a form of contraception acceptable to the Investigator from the time of signing informed consent until Study Discharge.
• Forms of contraception are:
• Sexually inactive (abstinent as a lifestyle) for 28 days prior to Day -2. A female subject who claims to be sexually inactive but becomes sexually active during the course of the study, must agree to use a physical barrier method (e.g., condom, diaphragm) with spermicide from the time of the start of sexual activity and throughout the study.
• Using birth control methods:
• hormonal oral contraceptives, vaginal ring, transdermal patch, or hormone or non-hormone releasing intrauterine device for at least 3 months prior to Day -2 and throughout the study.
• depot/implantable hormone (e.g., Depo-provera®, Implanon) for at least 3 months prior to Day -2 and throughout the study.

You may not qualify if:

• Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the Investigator, makes the study participant unsuitable to participate in this clinical study.
• History, presence of, or clinical laboratory test results indicating diabetes.
• Systolic blood pressure of \> 160 mmHg or a diastolic blood pressure of \> 95 mmHg, measured after being seated for five minutes.
• Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As needed treatment, such as inhalers, may be included at the Investigator's discretion pending approval from the Medical Monitor.
• Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
• Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
• Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to the signing of informed consent.
• Use of medication that impacts lung function biomarkers or other biomarkers within 2 weeks of study enrollment (i.e., Day -2), including acetylsalicylic acid (Aspirin) or ibuprofen and antibiotics. After enrollment, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the Investigator or designee.
• Participation in another clinical trial within (≤) 30 days prior to the signing of informed consent. The 30-day window for each subject will be derived from the date of the last study event in the previous study to the time of signing informed consent in the current study.
• Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
• Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
• A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening and Day -2.
• Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol result at Screening and Day -2.
• Hemoglobin level is \< 12.5 g/dL for females or \< 13.0 g/dL for males at the Screening Visit;
• History or presence of bleeding or clotting disorders;

Sponsors & Collaborators

• RAI Services Company: lead

Study Sites (1)

Celerion Lincoln

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation; Tobacco Use

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• Bobbette Jones, DrPH

  RAIS

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: July 27, 2021
• Study Start: May 30, 2019
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)