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SmokingNCT04979013

BRP1802 Smoking Abstinence Study

A study testing Smoking Abstinence in people with Smoking and Smoking Cessation, run by RAI Services Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 24 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Smoking, Smoking Cessation, Tobacco Use
What is being tested?
Smoking Abstinence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
30 May 2019to 5 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

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 24 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.
  • surgical sterilization of the partner (vasectomy for 4 months minimum) prior to Day -2.
  • physical barrier method (e.g., condom, diaphragm) with spermicide for at least 14 days prior to Day -2 and throughout the study.
  • Have undergone one of the following sterilization procedures at least 6 months prior to Day -2:
  • hysteroscopic sterilization
  • bilateral tubal ligation or bilateral salpingectomy
  • hysterectomy
  • bilateral oophorectomy
  • Agrees to in-clinic confinement of 17 days and 16 nights.
  • Agrees to have samples collected and stored for future use.

Who cannot join

  • 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.
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  • 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;
  • Any use of anticoagulants;
  • Whole blood donation within eight weeks (≤ 56 days) prior to the signing of informed consent;
  • Plasma donation within (≤) seven days prior to the signing of informed consent;
  • Weight of ≤ 110 kg;
  • Employed by a tobacco or nicotine company, the study site, or handles tobacco- or nicotine-containing products as part of their job.
  • Determined by the Investigator to be inappropriate for this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Celerion Lincoln

    Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: BRP1802 Changes in Biomarkers of Potential Harm Over Two Weeks of Smoking Abstinence

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.

Read the detailed description

The overall goal of the smoking abstinence study is to discover and assess biomarkers that respond rapidly to smoking abstinence and explore whether the smokers' age influences the responsiveness of biomarkers to changes in smoking status. The study is a single-center, parallel cohort, in which generally healthy adult male and female smokers participated. Smokers of 10-30 cigarettes per day for at least 5 years prior to screening were recruited. Plasma and urine (24h and spot urine) samples and other biological specimens will be collected at the baseline and at specified timepoints during the course of the study. The study will include two primary study cohorts, smokers ages 24-34 years and 35-60 years, to determine whether age could be a confounder in the qualification of biomarkers. Starting on Day -2, eligible smokers will be confined at the clinical site for 17 days. Biological samples will be collected on Days -2 and -1 for baseline study endpoints. On Day 1, smokers will be switched to smoking abstinence for 14 days. Samples will be collected for endpoint analysis throughout the 14-day abstinence period.

Being tested
Smoking Abstinence
Medical subject headings
Smoking, Smoking Cessation, Tobacco Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smoking AbstinenceOther

    Smokers will be switched to smoking abstinence for 14 days

Study groups in NCT04979013
Study groupRoleWhat they receive
Smoking AbstinenceExperimental14-day Smoking Abstinence
Receives: Other: Smoking Abstinence

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 14 days

Secondary outcomes (11)

  1. Urinary AA metabolites TxM and LTE4

    Change in Urinary AA metabolites TxM and LTE4

    Measured: 7 days

  2. Additional AA metabolites

    Change in additional AA metabolites:

    Tetranor-prostaglandin (t-PGDM); Tetranor-prostaglandin E metabolite (t-PGEM); 2,3-dinor-8-iso prostaglandin F2alpha (2,3-d-8-iso-PGF2α); 8-iso prostaglandin F 2alpha (8-iso-PGF2α); Prostaglandin F 2alpha (PGF2α); 11-dehydrothromboxane B2 (11-dh-TXB2); 20-carboxy-leukotriene B4 (20-COOH-LTB4); 20-hydroxy-leukotriene B4 (20-OH-LTB4)

    Measured: 14 days

  3. Biomarkers of Exposure in Urine: Nicotine equivalents and CEMA

    Change in biomarkers of exposure in Urine:

    Nicotine equivalents (molar sum of nicotine + 5 metabolites); 2-cyanoethylmercapturic acid (CEMA)

    Measured: 14 days

  4. Biomarkers of Exposure in Urine: TSNAs

    Change in biomarkers of exposure in Urine:

    Tobacco Specific Nitrosamine(s) (TSNAs)

    Measured: 14 days

  5. Biomarkers of Exposure in Blood: Carboxyhemoglobin

    Change in biomarkers of exposure in Blood:

    Whole blood carboxyhemoglobin

    Measured: 14 days

  6. Biomarkers of Exposure in Blood: nicotine and cotinine

    Change in biomarkers of exposure in Blood:

    Plasma nicotine; Plasma cotinine

    Measured: 14 days

  7. Biomarkers of Potential Harm: FeNO

    Change in biomarkers of potential harm:

    Fractional expired Nitric Oxide (FeNO)

    Measured: 14 days

  8. Biomarkers of Potential Harm: ABG

    Change in biomarkers of potential harm:

    Arterial Blood Gas (ABG)

    Measured: 14 days

  9. Nasal Mucociliary Clearance (NMC) Saccharin Transit Time (STT)

    Change in Nasal Mucociliary Clearance (NMC) Saccharin Transit Time (STT)

    Measured: 14 days

  10. T- and B-lymphocytes and Natural Killer (NK) cell profiles

    Change in T- and B-lymphocytes and Natural Killer (NK) cell profiles

    Measured: 14 days

  11. Changes in Platelet Aggregation

    Evaluation of platelet aggregation using Adenosine Diphosphate (ADP) as an agonist from baseline to Day 14. Platelet aggregation testing measures the ability of various agonists to platelets to induce ex vivo activation and platelet-to-platelet activation.

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2021
  2. Study start30 May 2019
  3. Primary completion5 Dec 2019
  4. Study completion5 Dec 2019

Resources

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 N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04979013
Sponsor's protocol ID
BRP1802
Status last verified
Jul 2021
First submitted
11 May 2021
Last updated
27 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Smoking Abstinence in people with Smoking and Smoking Cessation, run by RAI Services Company at 1 site 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 24 inclusion and 21 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 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Urinary Arachidonic Acid (AA) Metabolites 2,3-dinor-thromboxane B2 (TxM) and leukotriene E4 (LTE4) (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04979013.

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 27 Jul 2021.

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