This study will evaluate the individual and interactive pharmacokinetic and pharmacodynamic effects of smoked cannabis and nicotine.
The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). All participants will be healthy adult volunteers who are regular nicotine/tobacco users, and have prior experience with cannabis use. Participants will complete seven outpatient experimental test sessions (completed in a randomized order), under double-blind conditions in which participants will first self-administer smoked cannabis (either active or placebo), followed by nicotine (via a tobacco cigarette or an e-cigarette); there will also be one condition in which participants smoke active cannabis alone (without subsequent nicotine use). Nicotine self-administration will occur in an ad libitum fashion for 5 hours. Nicotine products will be the individual participant's preferred brand of cigarettes or the commercial pod-style e-cigarette the JUUL (pods will contain either 3% or 5% nicotine pods). Active cannabis will contain 10 mg tetrahydrocannabinol (THC) while placebo will contain 0 mg THC. During the ad libitum nicotine/tobacco-use period, various puffing behaviors (e.g., puff volume, puff duration, puff number, inter-puff-interval) will be measured using specialized equipment. Acute subjective effects of cannabis/nicotine, cannabis/nicotine withdrawal symptoms, craving, vital signs, and cognitive/psychomotor performance will also be assessed throughout the experimental sessions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
26
Johns Hopkins University
Baltimore, Maryland, United States
Amount of Nicotine (mL of Smoke/Vapor) Inhaled
Amount of nicotine used (determined by total volume (mL) of cigarette smoke or JUUL vapor inhaled) after cannabis exposure in each session.
Time frame: 0-5 hours
Mean Peak Change From Baseline Self-reported Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ)
Mean Peak Change From Baseline rating (0-100) of Drug Effect on the DEQ, with 0 being no effect and 100 being maximum effect.
Time frame: 0-5 hours
Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST)
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Total correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance).
Time frame: 0-5 hours
Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT)
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Total correct trials out of 90 recorded is primary outcome (higher scores indicate better performance).
Time frame: 0-5 hours
Mean Peak Change From Baseline Behavioral Task Performance as Assessed by the DRUID App
Behavioral task performance will be assessed with the DRUID app's Global impairment score (range 0-100), where lower scores indicate better performance.
Time frame: 0-5 hours
Mean Peak Change From Baseline Tobacco Craving as Assessed by the Tobacco Craving Questionnaire
Mean peak change from baseline rating (0-100) of "Craving" with 0 being no craving and 100 being maximum craving.
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Time frame: 0-5 hours
Mean Peak Change From Baseline Cannabis Craving as Assessed by the Cannabis Craving Questionnaire
Mean peak change from baseline rating (0-100) of "Craving" with 0 being no craving and 100 being maximum craving
Time frame: 0-5 hours