Clinical trial for Cigarette Smoking
Official title Catalyzing Cigarette Smoking Cessation Through Harm Reduction Sampling Among People Unmotivated to Quit
ClinicalTrials.gov ID: NCT07199517
What this study is testing
- What it's testing
- The study will compare two ways of trying harm‑reduction products with a standard nicotine patch and lozenge. It will look at how these options affect smoking habits, why they might work, and who benefits most.
- Who it's for
- Adults who smoke cigarettes but are not motivated to quit.
- What's involved
- Participants will pick either an e‑cigarette or an oral nicotine product, or receive a nicotine patch and lozenge. They will use the chosen product for four weeks and then be followed for six months with check‑ins and tests of their smoking behavior.
- Time commitment
- The study lasts about six months, with an initial four‑week product period and regular follow‑up visits or calls during the six‑month period.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older. Healthy volunteers may be eligible.
You may be able to join if
- Able to communicate fluently in English (i.e., speaking, writing, and reading)
- Male and female smokers who are \> 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least...
- Have a carbon monoxide (CO) greater than or equal to 10 ppm
- Not using any forms of nicotine regularly other than cigarettes.
- Not interested in quitting smoking in the next 30 days.
You likely can't join if
- Smoking Behavior
- Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, IQOS, ONPS, etc.).
- Current or impending (during the study period) enrollment or plans to enroll in a smoking cessation program.
- Current use of smoking cessation medication.
- Provide a CO breath test reading less than 10 ppm at Intake. Alcohol and Drug
- History of substance abuse (other than nicotine dependence) in the past 12 months.
See the full eligibility criteria
- Able to communicate fluently in English (i.e., speaking, writing, and reading)
- Male and female smokers who are \> 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.
- Have a carbon monoxide (CO) greater than or equal to 10 ppm
- Not using any forms of nicotine regularly other than cigarettes.
- Not interested in quitting smoking in the next 30 days.
- Capable of giving written informed consent, including compliance with the requirements and restrictions listed in the combined consent and HIPAA form
- Smoking Behavior
- Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, IQOS, ONPS, etc.).
- Current or impending (during the study period) enrollment or plans to enroll in a smoking cessation program.
- Current use of smoking cessation medication.
- Provide a CO breath test reading less than 10 ppm at Intake. Alcohol and Drug
- History of substance abuse (other than nicotine dependence) in the past 12 months.
- Current alcohol consumption that exceeds 20 standard drinks/week.
- Current use of recreational drugs (other than nicotine and cannabis) Medical
- Women, including all individuals assigned as "female" at birth, who are pregnant, breastfeeding, or planning a pregnancy over the duration of the study period.
- Serious or unstable disease within the past year (e.g. cancer, uncontrolled hypertension, cardiovascular event). Psychiatric 1\. Lifetime history of schizophrenia or psychosis. General Exclusion
- Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal...
- Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator.
- Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/o. people may be deemed ineligible at any point throughout the study.
The study team makes the final eligibility decision.
Where it is enrolling
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.