Effects of Cannabidiol on Stress and Nicotine Withdrawal
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-70
SponsorJohns Hopkins University
About this trial
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
Qualifiers
Healthy non-treatment seeking adults aged 21-70 (inclusive).
Use of > 5 cigarettes per day for > 2 years. (Use of other tobacco/nicotine products in addition to cigarettes will be acceptable).
Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level > 8 ppm.
Alcohol Use: < 2 drinks/day on average (< 14 drinks/week).
Disqualifiers
Report current intention to reduce or quit cannabis or tobacco use within the next 30 days
Meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine
Test positive for illicit drugs other than cannabis
Positive breath alcohol test (>.01 g/210L) at study admission
Trial design
Treatments tested in this trial
- Epidiolex
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
University of Minnesota
Collaborator
Source ClinicalTrials.gov