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Study Product A: Ploom HTP Menthol HTS; MX3 (681) for Tobacco Use

N/A

Recruiting

Research Sponsored by Altria Client Services LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Post-bronchodilator forced expired volume in 1 second (FEV1) : forced vital capacity (FVC) ratio > 0.7 and FEV1 > 80% of predicted at screening.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 5

Awards & highlights

Study Summary

This trial aims to see how switching to Ploom heated tobacco products affects the harmful substances in adult smokers compared to those who continue smoking regular cigarettes.

Who is the study for?

This trial is for adult smokers who are interested in switching from regular cigarettes to heated tobacco products (HTPs). Participants should be currently smoking and willing to switch or abstain as per the study's requirements. Specific details on inclusion and exclusion criteria were not provided.Check my eligibility

What is being tested?

The study is testing changes in exposure to harmful substances when smokers switch from traditional cigarettes to Ploom HTPs, both menthol and non-menthol versions, or choose smoking abstinence. It aims to compare these alternatives with continued use of usual brand combustible cigarettes.See study design

What are the potential side effects?

Potential side effects are not detailed here but may include typical nicotine withdrawal symptoms such as irritability, headache, hunger, and cravings if participants reduce nicotine intake during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My lung function tests show normal breathing capacity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

1-aminonaphthalene (1-AN)

2-Hydroxyethyl mercapturic acid (HEMA)

2-aminonaphthalene (2-AN)

+11 more

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Study Product D: Ploom HTP Tobacco HTS; R8 (120)Experimental Treatment1 Intervention

Subjects in D arm (Group 2 Non-menthol) will be required to smoke Ploom HTP Tobacco HTS; R8 (120) study product at least 5 times per day ad libitum from 07:00 through 23:00. There will be 60 subjects assigned to this arm with a randomization ratio of 2.

Group II: Study Product A: Ploom HTP Menthol HTS; MX3 (681)Experimental Treatment1 Intervention

Subjects in A arm (Group 1 Menthol) will be required to smoke Ploom HTP Menthol HTS; MX3 (681) study product at least 5 times per day ad libitum from 07:00 through 23:00. There will be 60 subjects assigned to this arm with a randomization ratio of 2.

Group III: Study Product B: Continue Smoking (menthol)Active Control1 Intervention

Subjects in B arm (Group 1 Menthol) will continue to smoke their menthol UBCC ad libitum from 07:00 through 23:00. There will be 60 subjects assigned to this arm with a randomization ratio of 2.

Group IV: Study Product C: Smoking Abstinence (menthol)Active Control1 Intervention

Subjects in C arm (Group 1 Menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases. There will be 30 subjects assigned to this arm with a randomization ratio of 1.

Group V: Study Product E: Continue Smoking (non-menthol)Active Control1 Intervention

Subjects in E arm (Group 2 Non-menthol) will continue to smoke their non-menthol UBCC ad libitum from 07:00 through 23:00. There will be 60 subjects assigned to this arm with a randomization ratio of 2.

Group VI: Study Product F: Smoking Abstinence (non-menthol)Active Control1 Intervention

Subjects in F arm (Group 2 Non-menthol) will remain abstinent from cigarette smoking for the duration of the study during both the confinement and ambulatory phases. There will be 30 subjects assigned to this arm with a randomization ratio of 1.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Altria Client Services LLCLead Sponsor

7 Previous Clinical Trials

1,458 Total Patients Enrolled

6 Trials studying Tobacco Use

1,058 Patients Enrolled for Tobacco Use

CelerionIndustry Sponsor

81 Previous Clinical Trials

7,514 Total Patients Enrolled

7 Trials studying Tobacco Use

1,290 Patients Enrolled for Tobacco Use

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many medical institutions is this clinical examination currently being conducted?

"Currently, patients are being recruited from a total of 7 different sites. These sites include Overland Park, Lexington, and Springfield, as well as several other locations across the country. To ensure convenience for participants, it is advisable to choose a clinic closest to their location in order to minimize travel requirements during their participation in the study."

Answered by AI

What is the current number of individuals who have been granted admission to participate in this clinical study?

"Indeed, as per the information available on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The initial posting of the study was on October 2nd, 2023, and the most recent update took place on December 12th, 2023. The trial aims to recruit a total of 300 patients from seven distinct locations."

Answered by AI

Is it possible for me to participate in this clinical investigation?

"To be eligible for participation in this research, potential candidates should have a history of tobacco use and fall within the age range of 22 to 65. The study aims to recruit a total of 300 individuals."

Answered by AI

Are there any available slots for patients to participate in this clinical trial?

"According to the data available on clinicaltrials.gov, this trial is currently in the recruitment phase. The trial was originally posted on October 2nd, 2023 and has recently been updated on December 12th, 2023."

Answered by AI

Does this clinical trial include individuals aged 80 and above as participants?

"To be eligible for participation in this trial, individuals must fall between the ages of 22 and 65. It should be noted that there are separate clinical trials available for those under the age of 18 (8 trials) and those over the age of 65 (35 trials)."

Answered by AI

Who else is applying?

What site did they apply to?

Dr. Vince Clinical Research, LLC

QPS Bio-Kinetic

Alliance for Multispecialty Research, LLC

What portion of applicants met pre-screening criteria?

Met criteria

Why did patients apply to this trial?

I have smoked cigarettes for 33 years and would very much like to quit. I have tried on my own several times to quit, and gave not been able to hoping this will be different.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

Changes in Biomarker of Exposure in Adults Who Smoke Cigarettes Switching From Cigarettes to Heated Tobacco Products

2023. "Changes in Biomarker of Exposure in Adults Who Smoke Cigarettes Switching From Cigarettes to Heated Tobacco Products". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06179290.

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