NCT07001930

Effects of Cannabidiol on Stress and Nicotine Withdrawal

Pharmacological Effects of Cannabidiol on Responses to Stress and Nicotine Withdrawal

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• CBD
• Stress
• Nicotine Dependence
• Tobacco Smoking

Interventions

Type	Name	Description
DRUG	Epidiolex	Oral cannabidiol

Timeline

• Start date: 2025-08-25
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2025-06-03
• Last updated: 2025-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study