NCT05707871 Cardiovascular Effects of Very Low Nicotine Content Cigarettes
| NCT ID | NCT05707871 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Tobacco Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 49 participants |
| Start Date | 2023-04-04 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 49 participants in total. It began in 2023-04-04 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study is measuring Cardiovascular effects of very low nicotine content cigarettes on daily and non-daily smokers
Eligibility Criteria
Inclusion Criteria: * Self-reported cigarette smoking at least once in the past 30 days * ≥21 years old * Willingness to smoke research cigarettes or usual brand cigarettes during lab visit. * Ability to speak, comprehend, and read English sufficiently to complete study procedures Exclusion Criteria: * Self-reported diagnosis of cardiovascular diseases like coronary artery disease, stroke, peripheral artery disease, cardiac arrhythmia, pulmonary embolism \& blood clots in legs and arm in the past 3 months * Body temperature ≥ 100.4˙F * Unstable health conditions interfering with electrocardiogram (ECG) measurements * Self-reported diagnosis of hyperthyroidism or thyrotoxicosis * Currently pregnant (as indicated by urine pregnancy test at the start of laboratory visit) or breastfeeding. * Currently seeking treatment to quit smoking
Contact & Investigator
Eric C Donny, PhD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT05707871 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Tobacco Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05707871 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05707871 currently recruiting?
Yes, NCT05707871 is actively recruiting participants. Contact the research team at manwar@wakehealth.edu for enrollment information.
Where is the NCT05707871 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT05707871 clinical trial?
NCT05707871 is sponsored by Wake Forest University Health Sciences. The principal investigator is Eric C Donny, PhD at Wake Forest University Health Sciences. The trial plans to enroll 49 participants.