Trial · NCT07899827
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma Nicotine Pharmacokinetics (Cmax) | At laboratory visits 2, 3, and 4, assessed up to 1 month | The maximum nicotine concentration observed in the plasma samples for each participant. |
| Primary | Plasma Nicotine Pharmacokinetics (Tmax) | At laboratory visits 2, 3, and 4, assessed up to 1 month | The time at which the maximum nicotine concentration is observed in the plasma samples for each participant. |
| Primary | Plasma Nicotine Pharmacokinetics (AUC_0-90) | At laboratory visits 2, 3, and 4, assessed up to 1 month | Area under the curve (AUC) of plasma nicotine levels from minute 0 to 90 for each participant. |
| Primary | Product Liking | At laboratory visits 2, 3, and 4, assessed up to 1 month | Participants will rate appeal (e.g., liking, disliking) on Visual Analogue Scales (range, 0-100). Higher scores indicate a greater degree of liking/disliking. |
| Primary | Product Appeal (mCEQ) | At laboratory visits 2, 3, and 4, assessed up to 1 month | 12-item modified Cigarette Evaluation Questionnaire (mCEQ) completed following ONP self-administration to assess subjective responses to the ONPs. The 12-item mCEQ includes five subscales: Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Scores for each subscale are calculated as the mean of the individual item responses or the single item. Higher scores indicate greater intensity on that scale. |
| Primary | Behavioral Economic Demand | At laboratory visits 2, 3, and 4, assessed up to 1 month | After product use, participants will complete a purchase task to assess demand indices including demand elasticity. |
| Primary | Craving Relief (QSU) | At laboratory visits 2, 3, and 4, assessed up to 1 month | Urges/craving will be measured using a modified version of the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU). This is a 10-item measure where participants rate items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, the investigators will collapse the items into two previously identified factors (Factor 1: strong desire and intention to use; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving. |
| Primary | Relief of Withdrawal Symptoms (MNWS) | At laboratory visits 2, 3, and 4, assessed up to 1 month | Nicotine withdrawal relief will be measured by the Minnesota Nicotine Withdraw Scale (MNWS). The MNWS asks users how much they are currently feeling certain nicotine withdraw symptoms on a scale of None (0), Slight, Moderate, Mild, or Severe (4). This measure assesses smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). MNWS is the sum of 8 items with scores ranging from 0 to 32 . |
| Primary | Intensity of Sensory Attributes (gLMS) | At laboratory visits 2, 3, and 4, assessed up to 1 month | 5-item self-report measure completed following ONP administration, using the general Labeled Magnitude Scale (gLMS). Scores range from 0 (no sensation) to 100 (strongest imaginable) with higher scores indicating a greater sensation intensity. |
| Primary | Behavioral Intentions | At laboratory visits 2, 3, and 4, assessed up to 1 month | Intentions to use the product again using the respective topography, purchase the product for personal use if required to use the topography, and use the product regularly following the topography. Self-report measure on a 7-point scale. Ratings range from 1 (extremely unlikely) to 7 (extremely likely) with higher scores indicating a higher likelihood of continuing to use the product. |
| Primary | Incidence of Adverse Effects | Up to 1 month | Adverse effects of interest include hiccups, headache, stinging or irritated gums, dry mouth, excess saliva, mouth sores or inflammation, cough, dizziness, sleepiness, and other participant-reported symptoms. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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