BridgeMD
Compares treatment options for Smoking Reduction
Official title Switching to E-cigarettes in Smokers Not Interested in Quitting
ClinicalTrials.gov ID: NCT05703672
What this study is testing
What is Varenicline Tartrate?
Varenicline Tartrate is an investigational medicine, given as an once-daily, being studied as a potential treatment for smoking reduction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objectives of this application are to 1) compare short- and long-term harm reduction and abuse liability potential of a nicotine salt pod-based electronic cigarettes (EC) in adult (AA) exclusive EC, dual cig-EC, and exclusive cig users, 2) characterize factors that predict who switches fully, partially, or not at all, and 3) examine if harm reduction can be further enhanced by treating dual users with varenicline (VAR) to eliminate cigarette smoking.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, 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
- ≥ 21 years of age
- Smoke \>5 cigarettes per day
- Smoked cigarettes for \> 6 months
- Verified smoker (CO \> 5 ppm)
- Functioning telephone
You likely can't join if
- Interested in quitting smoking
- Use of smoking cessation pharmacotherapy in the month prior to enrollment
- Use of other tobacco products in past 30 days (i.e., cigarillos, cigars, hookah, smokeless tobacco, pipes)
- EC use on \> 4 of the past 30 days
- Uncontrolled hypertension: BP \> 180 (systolic) or \> 105 (diastolic)
- Heart-related event in the past 30 days
See the full eligibility criteria
- ≥ 21 years of age
- Smoke \>5 cigarettes per day
- Smoked cigarettes for \> 6 months
- Verified smoker (CO \> 5 ppm)
- Functioning telephone
- Interested in switching to EC
- Willing to take varenicline and complete all study visits
- Interested in quitting smoking
- Use of smoking cessation pharmacotherapy in the month prior to enrollment
- Use of other tobacco products in past 30 days (i.e., cigarillos, cigars, hookah, smokeless tobacco, pipes)
- EC use on \> 4 of the past 30 days
- Uncontrolled hypertension: BP \> 180 (systolic) or \> 105 (diastolic)
- Heart-related event in the past 30 days
- Medical contraindications to VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; history of clinically significant allergic reactions; history...
- Pregnant, contemplating getting pregnant, or breastfeeding
- Plans to move from Kansas City metro area during the treatment and follow-up phase
- Another household member enrolled in the study
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Missouri, 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 - 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?
Study sites include Kansas City, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.