The purpose of this study is to examine the effect of doses of cannabidiol (CBD) during exposure to stress and nicotine withdrawal in nicotine users. The main objectives of the study include examining the effect CBD has on stress, tobacco dependence, tobacco withdrawal, and sex differences between these types of stress. Participants will be administered CBD and exposed to stress. Biological and subjective measures will be collected. Participants may be asked to stop use for 24 hours. Researchers will also investigate withdrawal effects between participants who have not smoked nicotine in 24 hours and those who have continued to smoke before each session.
This study will use a double-blind, placebo-controlled, within-subjects crossover design to examine the effect of acute doses of CBD during exposure to acute stress and nicotine withdrawal using a relevant set of biological and subjective measures that are known to be sensitive to acute stress and to nicotine withdrawal. There will be one in-person medical screening session, 3 pre-laboratory phone sessions, and 3 in-person experimental laboratory sessions separated by at least 72 hrs. Total duration for a study completer is estimated to be 2-3 weeks. Three doses of CBD (0mg, 200mg, and 400mg) will be administered, one at each of three separate laboratory sessions that will last approximately 5 hours each and be separated by at least 72 hours. Two effective induction challenges will be implemented: one is behavioral (an established and well validated acute psychological stress induction) and one is a nicotine withdrawal challenge (24 hours abstinence from all nicotine products). Nicotine users reporting daily cigarette use (N=90) will be recruited. Nicotine users will be randomly assigned to continue nicotine use ad libitum or to abstain for 24 hours before each of three laboratory sessions. Randomization will be stratified based on participant sex and current use of other tobacco products (e.g. e-cigarettes, smokeless tobacco, pouches, cigars/cigarillos). Participants who use other nicotine-related products (e.g., e-cigarettes) will be accepted in the study if they also smoke cigarettes. Use of other nicotine products will be assessed and tracked to account for their effects on the collected measures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
90
Oral cannabidiol
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States
RECRUITINGNegative Affect as assessed by the Subjective State Scale
Negative affect is measured using the Subjective State Scale which includes 4 items measuring negative affect. The scale has a range of 0 to 28 with higher scores indicating greater negative affect.
Time frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
Positive Affect as assessed by the Subjective State Scale
Positive affect is measured using the Subjective State Scale which includes 5 items measuring positive affect. The scale has a range of 0 to 35 with higher scores indicating greater positive affect.
Time frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
Blood Plasma Cortisol level
Blood plasma cortisol will be collected during laboratory stress testing sessions using a 20-gauge IV Teflon catheter inserted in a non-dominant forearm vein.
Time frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
Salivary Cortisol level
Salivary cortisol will be collected during laboratory stress sessions using Salivette tubes and assayed using time-resolved fluorescence immunoassay.
Time frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
Plasma Concentration of Endocannabinoids
Blood plasma endocannabinoids will be collected during laboratory stress testing sessions using a 20-gauge IV Teflon catheter inserted in a non-dominant forearm vein.
Time frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
Heart Rate (beats per minutes)
Heart rate will be collected during laboratory stress testing sessions.
Time frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
Systolic Blood Pressure (mmHg)
Systolic blood pressure will be collected during laboratory stress testing sessions.
Time frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
Diastolic Blood Pressure (mmHg)
Diastolic blood pressure will be collected during laboratory stress testing sessions.
Time frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
Subjective Pain as assessed by the McGill Pain Questionnaire short form (MPQ)
Subjective pain will be measured immediately after the cold pressor task (CPT) at each stress session using the McGill Pain Questionnaire short form, with a score range of 0 to 78, with higher values indicating more significant pain.
Time frame: 170 minute timepoint
Nicotine urge as assessed by the Questionnaire on Smoking Urges (QSU-brief)
Nicotine urge will be measured using the Questionnaire on Smoking Urges (QSU-brief) includes 10 items on a likert scale from 1 to 7. Total score range is 7 to 70, higher scores more nicotine urge.
Time frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
Craving for Sweet and Rich Foods as assessed by the Questionnaire on Craving for Sweet and Rich Food,
Craving for sweet and rich foods will be measured using the Questionnaire on Craving for Sweet and Rich Food, which includes one question assessing craving sweet or rich foods at the current moment, with scores ranging from 1 to 7, with higher scores indicating greater craving.
Time frame: 200 minute timepoint
Hypothetical Tobacco Demand
Hypothetical tobacco demand will be measured using a cigarette purchase task after each laboratory stress session. Change in demand (amplitude and persistence) will be assessed to create an overall demand curve.
Time frame: 200 minute timepoint
Sustained Attention to Response Task
Sustained attention will be measured using the Sustained Attention to Response Task. Errors of commission and errors of omission will be assessed during the recovery period at each laboratory stress session.
Time frame: 200 minute timepoint
Reaction time on the N-Back Cognitive test
N-back task (0 back and 1 back) accuracy will be used to measure working memory during the recovery period at each laboratory stress session. Participants will be exposed to a series of numbers and will be asked to respond on a keypad when the current number matches a number presented "n" trials back.
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Time frame: 200 minute timepoint