Acute Effects of Oral Nicotine Pouches

Phase 1RecruitingNCT07128329

Johns Hopkins University120 enrolled

Overview

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 the participants use nicotine pouches under controlled conditions. The investigators 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).

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 the participant's own control). Smokers will be instructed to abstain from all tobacco 12 hours prior to each session so that the participants 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

120

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria (all participants): * greater than or equal to 21 years old * good general health based on screening procedures * vital signs in normal range (resting heart rate less than 110bpm, systolic blood pressure less than 150mmHg, diastolic blood pressure less than 100mmHg) * negative urine test for illicit drug use (excluding THC) and negative breath alcohol test at screening and before each session * no self-reported prior use of oral nicotine pouches * Not actively trying to quit smoking or using smoking cessation medication (e.g., nicotine replacement therapy) Additional inclusion criteria (smokers): * self-report currently smoking cigarettes daily * exhaled breath CO greater than or equal to 10ppm and urine cotinine greater than 100 ng/ml at screening * meet criteria for tobacco use disorder * no self-reported regular use of other tobacco products (e.g., smokeless products, e-cigarettes) in the past 30 days Additional inclusion criteria (non-nicotine users): * self-report previously using nicotine/tobacco but no more than 100 lifetime uses across all routes of administration * no self-reported nicotine/tobacco uses in the past 30 days * urine cotinine less than 100 ng/ml at screening. Exclusion criteria (all participants): * psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month * current use of OTC drugs, supplements/vitamins, or prescription medications that, in the opinion of medical staff, will impact safety * currently have severe dependence for cannabis * history of or current significant medical condition that, in the opinion of medical staff, will impact safety * current psychiatric condition or substance use disorder (aside from tobacco use disorder for smokers), that, in the opinion of medical staff, will impact safety * women who are pregnant, planning to become pregnant, or are breast-feeding

Outcomes

Primary Outcomes

Pharmacokinetics - CMax for nicotine

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.

Time frame: 6.5 hours

Pharmacokinetics - AUC for nicotine

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.

Time frame: 6.5 hours

Drug Effect Questionnaire-Like Drug Effect

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.

Time frame: 6.5 hours

Drug Effect Questionnaire-pleasant Drug Effect

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.

Time frame: 6.5 hours

Drug Effect Questionnaire-take again

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.

Time frame: 6.5 hours

Topography - number of pouches used

During the 2 hour ad libitum bout, primary topography variable will be collected - the total number of pouches used (range 0 - 5)

Time frame: 2 hours

Topography - duration of use

During the 2 hour ad libitum bout, primary topography variable will be collected - total duration of use (range 0 - 2 hours).

Time frame: 2 hours

Hughes-Hatsukami Withdrawal Questionnaire

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.

Time frame: 6.5 hours

Tiffany-Drobes Questionnaire on Smoking Urges (QSU) brief

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.

Time frame: 6.5 hours

Secondary Outcomes

Pharmacokinetics - Tmax for nicotine

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

Time frame: 6.5 hours

The Direct Effects of Nicotine Scale (DENS)

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).

Time frame: 6.5 hours

Drug Effects Questionnaire (DEQ) - feel drug effect

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.

Time frame: 6.5 hours

Drug Effects Questionnaire (DEQ) subjective effects- unpleasant effect

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.

Time frame: 6.5 hours

Drug Effects Questionnaire (DEQ) subjective effects- dislike drug effect

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.

Time frame: 6.5 hours

Acute Effects of Oral Nicotine Pouches

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts