Trial Outcomes & Findings for Vaping THC From Electronic Cigarettes (NCT NCT02955329)

A total of 8 total participants received all 3 interventions over the course of 3 days, with the sequence of the interventions varied for each participant. The order of treatment (cannabis leaf, tobacco with nicotine, cannabis leaf \& tobacco with nicotine) will be counterbalanced between subjects

Vaping THC From Electronic Cigarettes

Delivered Tetrahydrocannabinol (THC) and nicotine doses are estimated as the change in e-cigarette weight × concentration of THC or nicotine in e-liquid. The amount of THC or nicotine systemically retained is estimated as delivered dose minus amount in gas traps.

Median peak concentration of THC between vaped loose-leaf cannabis, mixture of cannabis and tobacco containing nicotine, and the tobacco alone treatment condition will be reported

Median peak concentration of nicotine between vaped loose-leaf cannabis, mixture of cannabis and tobacco containing nicotine, and the tobacco alone treatment condition will be reported

Median exposure of nicotine using area under the blood/plasma concentration-time curve(AUC) between vaped loose-leaf cannabis, mixture of cannabis and tobacco containing nicotine, and the tobacco alone treatment condition will be reported

Compare median exposure of nicotine using AUC (area under the blood/plasma concentration-time curve) between vaped loose-leaf tobacco containing nicotine vs. mixture of cannabis and tobacco containing nicotine.

Heart rate monitoring by pulse oximeter

The Drug Effects Questionnaire (DEQ) is widely used in studies of acute subjective response (SR) to a variety of substances which assessed the extent to which participants (1) feel any substance effect(s), (2) feel high, (3) like the effects, (4) dislike the effects, and (5) want more of the substance by instructing participants to place a mark on a 100mm vertical, visual, analog scale with scores ranging from 0 ="not at all" to 100 = "extremely" for each question. The mean of the individual responses is used to general a total score with a range from 0 to 100, with higher scores indicate a greater "liking" of the effects of the substance. The mean and standard deviation of each treatment condition will be reported.

This 12-item multidimensional measure assesses cannabis craving based on 4 factors: Compulsivity, Emotionality, Expectancy, Purposefulness. Each item asks about the respondent's feelings and thoughts about smoking marijuana as he or she is completing the questionnaire (i.e., right now). Each response is scored a number ranging from 1 (strongly disagree) to 7 (strongly agree) with higher scores indicating a greater level of craving. The calculation of each subscale is as follows: Compulsivity: Mean of items 2, 7, and 10; Emotionality: Mean of items 4, 6, and 9; Expectancy: Mean of items 5, 11, and 12; Purposefulness: Mean of items 1, 3, and 8 with the minimum possible score = 1 and the maximum possible score = 7 for any subscale. The mean and standard deviation of each subscale for each treatment condition will be reported.

The modified Cigarette Evaluation Questionnaire (mCEQ) uses three multi-item subscales and two single items: "Smoking Satisfaction" (items 1, 2, and 12);"Psychological Reward" (items 4 through 8); "Aversion" (items 9 and 10);"Enjoyment of Respiratory Tract Sensations" (item 3); and "Craving Reduction"(item 11). Scores for each subscale are calculated as the mean of the individual item responses or the single item. Higher scores indicate greater intensity on that scale. Items are rated on a seven-point scale ranging from 1 (not at all) to 7 (extremely) and total scores are averaged across all items with a minimum average score of 1 and a maximum average score of 7. Higher scores indicate greater intensity of each smoking effect with, for example, greater satisfaction or psychological reward after smoking. The mean and standard deviation for each treatment condition will be reported.

The Positive and Negative Affect Schedule (PANAS) is a brief scale is comprised of 20 items, with 10 items measuring positive affect (e.g., excited, inspired) and 10 items measuring negative affect (e.g., upset, afraid). Each item is rated on a five-point Likert Scale, ranging from 1 = Very Slightly or Not at all to 5 = Extremely, to measure the extent to which the affect has been experienced in a specified time frame and the final score is derived out of the sum of the ten items on both the positive and negative side. Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.

The Minnesota Nicotine Withdrawal Scale is an 7-item self - report scale designed to measure the severity of craving and withdrawal symptoms experienced during smoking cessation. Each item is rated on a scale of 0 to 4 with 0=none,1= Slight, 2= Mild, 3= Moderate, and 4=Severe. Seven of the items are symptoms derived from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Tobacco Withdrawal diagnosis and are as follows: depression, insomnia, irritability/frustration/anger, anxiety/nervousness, difficulty concentrating, restlessness, increased appetite and at least five of seven items must have responses in order to generate a reliable score. The responses to each item are summed to produce a total withdrawal summary score with greater scores indicating a higher level of severity in nicotine withdrawal symptoms overall. The mean and standard deviation of each treatment condition will be reported with a minimum mean score of 0 and a maximum mean score of 4.