Acute Effects of Oral Nicotine Pouches
- Conditions
- Nicotine Pouch Self-AdministrationNicotine Pharmacokinetic StudyNicotine Pharmacodynamic Study
- Interventions
- Registration Number
- NCT07128329
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
The present human laboratory study will recruit cigarette smokers (n=60) and adult infrequent nicotine users (n=60) to complete two counterbalanced lab sessions in which they use nicotine pouches under controlled conditions. We are recruiting both frequent and infrequent nicotine users because FDA regulates tobacco products based on a public health standard, meaning FDA must consider the impact a regulation may have on the population as a whole (e.g., people who use and do not use tobacco products currently).
- Detailed Description
This study will be conducted at the Johns Hopkins Behavioral Pharmacology Research unit (BPRU). Participants will complete a screening visit, and, if eligible, will then complete 2 outpatient experimental sessions (separated by at least 48 hours). The study will use a mixed between/within-subjects crossover design. The between-subjects component is because there are two groups of participants (60 cigarette smokers, 60 infrequent nicotine users) and the within-subjects component is because participants complete all experimental sessions (thus, serving as their own control). Smokers will be instructed to abstain from all tobacco 12 hours prior to each session so that they begin study sessions in a state of nicotine/tobacco withdrawal. Sessions will be completed in a counterbalanced order to reduce order effects. During each experimental session, a battery of assessments including subjective questionnaires (abuse liability, nicotine-related effects, withdrawal suppression), cognitive performance, blood collection for pharmacokinetic analysis (this will be optional), vital signs, and pouch use (or topography) will be conducted
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Pouch label version 1 Nicotine Pouches Nicotine pouches with label 1 Pouch label version 2 Nicotine Pouches Nicotine pouches with label 2
- Primary Outcome Measures
Name Time Method Drug Effect Questionnaire-take again 6.5 hours The DEQ will be used to obtain subjective ratings of "take again". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Pharmacokinetics - CMax for nicotine 6.5 hours Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Maximum concentration (Cmax), is the highest plasma nicotine concentration reached during a session and provides important insight into the abuse liability of a tobacco product.
Pharmacokinetics - AUC for nicotine 6.5 hours Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Area under the curve (AUC), represents the total nicotine exposure during an entire session and provides important insight into the abuse liability of a tobacco product.
Topography - number of pouches used 2 hours During the 2 hour ad libitum bout, primary topography variable will be collected - the total number of pouches used (range 0 - 5)
Topography - duration of use 2 hours During the 2 hour ad libitum bout, primary topography variable will be collected - total duration of use (range 0 - 2 hours).
Drug Effect Questionnaire-Like Drug Effect 6.5 hours The DEQ will be used to obtain subjective ratings of "like drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Drug Effect Questionnaire-pleasant Drug Effect 6.5 hours The DEQ will be used to obtain subjective ratings of "pleasant drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Hughes-Hatsukami Withdrawal Questionnaire 6.5 hours The HHWS will be used to obtain subjective ratings of tobacco withdrawal outcomes among smokers including: "urge", "craving" "Anxious," "Depression," " Difficultly concentrating," "Drowsy," "Hunger," "Impatient," "Irritable," "Restlessness," "Desire for sweets". Scores for these items range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Tiffany-Drobes Questionnaire on Smoking Urges (QSU) brief 6.5 hours The QSU-brief will measure tobacco withdrawal symptoms in smokers using 10 items that form 2 factors: factor 1 (intention to smoke) and factor 2 (anticipation of withdrawal symptom relief). Mean score 0-5. Lower score is better.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics - Tmax for nicotine 6.5 hours Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Time to max concentration (Tmax), is the time (in min) to reach Cmax. This is another measure relevant for abuse liability. Range is 0 - 20 min for directed period
The Direct Effects of Nicotine Scale (DENS) 6.5 hours The DENS will assess nicotine-specific effects via 10 items "Confused," "Dizzy," "Headache," "Heart Pound," "Lightheaded," "Nauseous," "Nervous," "Salivation," "Sweaty," and "Weak". Each item is scored separately from 0 (not at all) to 100 (extremely).
Drug Effects Questionnaire (DEQ) - feel drug effect 6.5 hours The DEQ will assess subjective ratings for "feel drug effect". Scores range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Drug Effects Questionnaire (DEQ) subjective effects- unpleasant effect 6.5 hours The DEQ will assess subjective ratings for "unpleasant drug effect". Scores range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Drug Effects Questionnaire (DEQ) subjective effects- dislike drug effect 6.5 hours The DEQ will assess subjective ratings for "dislike drug effect". Scores range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Trial Locations
- Locations (1)
Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit (Bayview)
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit (Bayview)🇺🇸Baltimore, Maryland, United States