The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of cigarettes. The study's goals are to test demand for cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke cigarettes and either smoke or vape THC in the laboratory.
A full-factorial laboratory study will be conducted to determine the impact of acute THC administration on the dose-related motivational, subjective, and physiological effects of combustible cigarettes. This study will employ a double-blind, placebo-controlled, within-subjects crossover design to examine the dose-effects of THC on combustible tobacco use. The study will use multiple active doses of THC and placebo (0, 5, and 30 mg; corresponding to 0, 1, and 6 standard THC unit doses). Participants will be randomized to either smoked or vaporized THC administration using a between-subjects approach to evaluate the effect of congruent versus incongruent routes of THC and tobacco administration on study outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
100
Johns Hopkins University Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States
RECRUITINGDemand Intensity
Consumption of cigarette puffs at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more consumption at unconstrained price (a worse outcome).
Time frame: 45 minutes after THC or placebo administration
Demand Elasticity
Changes in cigarette consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater cigarette price sensitivity (a better outcome).
Time frame: 45 minutes after THC or placebo administration
Minnesota Nicotine Withdrawal Scale (MNWS)
A subjective effect measure of nicotine withdrawal. Minimum value is 0, maximum value is 68. Higher scores indicate greater nicotine withdrawal (a worse outcome). Primary outcomes will be the peak change from baseline.
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Brief Questionnaire of Smoking Urges (QSU - Brief) Factor 1
Self report assessment smoking urges. Factor 1 - Intention/Desire to Smoke. Score minimum is 7, Score Maximum is 35. Primary outcomes will be the peak change from baseline.
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Brief Questionnaire of Smoking Urges (QSU - Brief) Factor 2
Self report assessment smoking urges. Factor 2 - Relief of Negative Affect \& Urgent Desire to Smoke. Score minimum is 7, Score Maximum is 35. Primary outcomes will be the peak change from baseline.
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
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Full nicotine cigarette
Reduced nicotine cigarette
Drug Effect Questionnaire for Like Drug
The Drug Effect Questionnaire will be administered using a visual analog scale. Participants place a mark on a 100mm line with the left endpoint labeled Not at All and the right endpoint labeled Extremely. Primary outcomes will be the peak change from baseline.
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Heart Rate
Heart rate will be recorded using an automated vital signs monitor to monitor safety and provide an objective index of the time course and magnitude of drug effects. Primary outcomes will be the peak change from baseline.
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Diastolic Blood Pressure
Diastolic Blood Pressure will be recorded using an automated vital signs monitor to monitor safety and provide an objective index of the time course and magnitude of drug effects. Primary outcomes will be the peak change from baseline.
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Systolic Blood Pressure
Systolic Blood Pressure will be recorded using an automated vital signs monitor to monitor safety and provide an objective index of the time course and magnitude of drug effects. Primary outcomes will be the peak change from baseline.
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
Divided Attention Task (DAT) Performance
Participants will complete a Divided Attention Task (DAT) in which the participant must simultaneously track a stimulus moving horizontally on a computer screen and respond to visual stimuli presented. The primary dependent measure is the average distance maintained from the target stimulus. Primary outcomes will be the peak change from baseline.
Time frame: Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.