Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers
Nicotine Withdrawal, Nicotine Addiction, Drug Effect
About this trial
This is an interventional basic science trial for Nicotine Withdrawal
Eligibility Criteria
Inclusion Criteria:
- over 21 years old
- good general health based on screening procedures (e.g., physical exam, blood testing)
- vital signs in normal range (resting heart rate less than 100bpm, systolic blood pressure less than 160mmHg, diastolic blood pressure less than 90mmHg)
- negative urine test for illicit drug use (excluding THC) and negative breath alcohol test at screening and before each session
- self-report currently smoking 10 or more cigarettes per day
- self-report at least a one year history of regular smoking
- exhaled breath CO greater than or equal to 10ppm and urine cotinine greater than 100 ng/ml at screening
- meet criteria for moderate to severe tobacco use disorder (DSM-V and FTND)
- no self-reported regular use of other tobacco products (e.g., smokeless products, e-cigarettes) in the past 30 days
- no self-reported prior use of novel oral nicotine pouches
- exhaled breath CO less than 10 ppm upon arrival for each study session.
Exclusion Criteria:
- Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
- Current use of over-the-counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigators or medical staff, will impact safety
- Use of cannabis >2 times per week
- History of or current significant medical condition that, in the opinion of the investigators or medical staff, will impact safety
- Current psychiatric condition or substance use disorder (aside from tobacco use disorder) that, in the opinion of the investigators or medical staff, will impact safety or study outcomes
- Women who are pregnant, planning to become pregnant, or are breast-feeding
- Currently seeking treatment to quit smoking or currently using a nicotine/tobacco cessation product.
- Enrollment in another clinical trial in the past 30 days
Sites / Locations
- Johns Hopkins Behavioral Pharmacology Research UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Original/Tobacco Flavored Pouch (low nicotine dose)
Original/Tobacco Flavored Pouch (high nicotine dose)
Mint/Menthol Flavored Pouch (low nicotine dose)
Mint/Menthol Flavored Pouch (high nicotine dose)
Fruit Flavored Pouch (low nicotine dose)
Fruit Flavored Pouch (high nicotine dose)
Own brand cigarettes
participants will use a tobacco flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
participants will use a tobacco flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
participants will use a mint/menthol flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
participants will use a mint/menthol flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
participants will use a fruit flavored pouch (4mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
participants will use a fruit flavored pouch (8mg nicotine dose)under both controlled (experimenter-directed) and ad libitum use conditions
participants will smoke participants' own brand of cigarettes under both controlled (experimenter-directed) and ad libitum use conditions