Effects of Oral Cannabidiol on Stress and Nicotine Withdrawal in Adults Who Smoke Tobacco

What this Trial Is About

Researchers are studying how different doses of cannabidiol CBD affect stress and nicotine withdrawal in adults who smoke tobacco cigarettes. The study focuses on how CBD influences stress responses, tobacco dependence, withdrawal symptoms, and sex differences during stress. The trial uses a phase 1, double-blind, placebo-controlled, crossover design involving nicotine users who smoke daily and may also use other tobacco products. The aim is to measure biological and subjective effects during exposure to stress and nicotine withdrawal. Participants will attend an initial in-person medical screening, followed by three pre-laboratory phone sessions and three in-person experimental laboratory sessions. Each laboratory session lasts about 5 hours and occurs at least 72 hours apart. During these sessions, participants receive one of three doses of CBD 0 mg, 200 mg, or 400 mg and are exposed to two stress challenges a psychological stress test and a nicotine withdrawal challenge involving 24-hour abstinence from nicotine. Participants are randomly assigned to either continue smoking as usual or abstain from nicotine for 24 hours before sessions, with randomization considering sex and use of other tobacco products. Throughout the study, researchers collect biological samples and subjective measures at multiple time points to assess negative and positive mood states, cortisol levels in blood and saliva, endocannabinoid plasma concentrations, heart rate, and blood pressure. Additional assessments include pain, nicotine urge, craving for sweet foods, tobacco demand, attention, and cognitive reaction time. The total participation time is estimated to be 2 to 3 weeks. Safety and adherence are monitored during the study, which is sponsored by Johns Hopkins University.

Effects of Cannabidiol on Stress and Nicotine Withdrawal