Cigarette Smoking-Related Carcinoma Clinical Trial
Official title:
Synthetic Cooling Agents in Combustible Cigarettes: A Pilot Study
This clinical trial evaluates the impact of synthetic cooling agents in combustible cigarettes on smoking perceptions and use. Menthol, a natural chemical, is a cooling agent that increases nicotine dependence among smokers. Menthol cigarettes largely contribute to the huge burden that smoking puts on public health. Approximately 43% of adult smokers smoke menthol cigarettes. Regulatory agencies have begun a ban on menthol. In response to the ban, the tobacco industry has introduced synthetic cooling agents as a flavorless replacement to provide the same cooling effects as menthol. Information gained from this trial may help researchers determine how the addition of synthetic cooling agents changes the appeal, abuse liability potential, and respiratory toxicity profile of combustible cigarettes.
PRIMARY OBJECTIVES: I. Assess the content of synthetic cooling agents in newly introduced cooling agent non-menthol, menthol, and traditional non-menthol cigarettes. II. Assess the subjective effects and abuse liability of cooling agent non-menthol cigarettes. EXPLORATORY OBJECTIVE: I. Examine acute changes to pulmonary health associated with cooling agent cigarette use. OUTLINE: Participants are randomized to use 1 of 3 cigarette conditions at 3 different study visits. Participants participate in ad libitum smoking sessions with either a non-menthol control, menthol, or synthetic cooling agent cigarette condition once weekly (QW) over 3 weeks on study. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the study cigarette condition at the end of each study visit. Participants also undergo nasal swab collection over 5-10 minutes and spirometry and airwave oscillometry testing over 5-10 minutes pre- and post-smoking session at each study visit. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06038526 -
Evaluation of Canakinumab in High-Risk Former-Smokers
|
Phase 2 | |
| Recruiting |
NCT05121051 -
Testing the Effect of the Broccoli Seed and Sprout Extract, Avmacol ES, on the Cancer Causing Substances of Tobacco in Heavy Smokers
|
Phase 2 | |
| Not yet recruiting |
NCT06386432 -
EQQUAL-NM for the Promotion of Smoking Cessation in Sexual and Gender Minority Young Adults in New Mexico
|
N/A | |
| Active, not recruiting |
NCT02964182 -
Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers
|
N/A | |
| Completed |
NCT04510077 -
SmartQuit Program for Smoking Cessation
|
N/A | |
| Completed |
NCT04525222 -
mHealth Mood Management Tool (Actify) to Improve Population-Level Smoking Cessation
|
Phase 1 | |
| Completed |
NCT05455086 -
Free-Base Nicotine or Nicotine Salt e-Liquids in Current E-Cigarette Smokers, PeloPET Study
|
N/A | |
| Recruiting |
NCT06010355 -
Culturally Tailored Educational Video to Promote Lung Cancer Screening in Vulnerable Communities
|
N/A | |
| Completed |
NCT05236894 -
Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population
|
Early Phase 1 | |
| Recruiting |
NCT05825001 -
Evaluating the Episodic Future Thinking Intervention for Reducing Cigarette Consumption in Cigarette Smokers
|
N/A | |
| Not yet recruiting |
NCT06213532 -
CONNECTing to LungCare
|
N/A | |
| Recruiting |
NCT03856515 -
Gender Differences in Switching From Smoking Regular Cigarettes to E-Cigarettes
|
N/A | |
| Completed |
NCT03480373 -
Electronic Cigarette Use During Pregnancy
|
||
| Not yet recruiting |
NCT06055231 -
PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
|
Phase 1 | |
| Active, not recruiting |
NCT04308759 -
An Innovative Conversational Agent (Quitbot) for Smoking Cessation
|
Phase 3 | |
| Active, not recruiting |
NCT04972513 -
Impact of E-cigarette Use on the Body
|
||
| Withdrawn |
NCT05024955 -
Evaluating Shared Decision-Making for Lung Cancer Screening Among Chinese Populations in the United States
|
||
| Completed |
NCT05227027 -
Pilot Trial of a Game Embedded in a Smartphone App for Smoking Cessation
|
N/A | |
| Completed |
NCT04502524 -
Website Smoking Cessation Intervention for the Promotion of Smoking Cessation in Low-Income Veterans
|
Phase 1 | |
| Completed |
NCT03402230 -
Broccoli Sprout/Broccoli Seed Extract Supplement in Decreasing Toxicity in Heavy Smokers
|
Early Phase 1 |