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Recruiting Phase 1 NCT07001930

NCT07001930 Effects of Cannabidiol on Stress and Nicotine Withdrawal

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Clinical Trial Summary
NCT ID NCT07001930
Status Recruiting
Phase Phase 1
Sponsor Johns Hopkins University
Condition CBD
Study Type INTERVENTIONAL
Enrollment 90 participants
Start Date 2025-08-25
Primary Completion 2029-09-01

Trial Parameters

Condition CBD
Sponsor Johns Hopkins University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 90
Sex ALL
Min Age 21 Years
Max Age 70 Years
Start Date 2025-08-25
Completion 2029-09-01
Interventions
Epidiolex

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Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Healthy non-treatment seeking adults aged 21-70 (inclusive). 2. Use of \> 5 cigarettes per day for \> 2 years. (Use of other tobacco/nicotine products in addition to cigarettes will be acceptable). 3. Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level \> 8 ppm. 4. Alcohol Use: \< 2 drinks/day on average (\< 14 drinks/week). 5. Sleep schedule: No graveyard or third shift work (i.e., participants must report a normal nighttime sleep schedule). 6. For women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study and for at least 30 days after the last study drug administration. Exclusion Criteria: 1. Report current intention to reduce or quit cannabis or tobacco use within the next 30 days 2. Meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine 3. Test pos

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