Actively Recruiting
Pharmacological Effects of Cannabidiol on Responses to Stress and Nicotine Withdrawal
Led by Johns Hopkins University · Updated on 2025-09-02
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how different doses of cannabidiol (CBD) affect stress and nicotine withdrawal symptoms in adults who use nicotine daily. The study focuses on understanding how CBD influences stress responses, tobacco dependence, withdrawal symptoms, and differences between sexes during stress. Participants will be exposed to stress and may be asked to abstain from nicotine for 24 hours to evaluate withdrawal effects. The study uses a double-blind, placebo-controlled, crossover design where each participant receives three doses of CBD (0 mg, 200 mg, and 400 mg) across three separate sessions, each lasting about 5 hours and spaced at least 72 hours apart. Participants are randomly assigned to either continue smoking as usual or abstain from nicotine for 24 hours before each session. The study includes behavioral stress challenges and nicotine withdrawal challenges to assess responses. Participants will attend one medical screening, three phone sessions, and three in-person experimental sessions over 2 to 3 weeks. During sessions, biological samples and subjective reports will be collected at multiple time points to measure mood, cortisol levels, heart rate, blood pressure, and nicotine urges. Various questionnaires and cognitive tests will evaluate pain, cravings, tobacco demand, attention, and reaction times. The study monitors safety and collects detailed data to understand CBD's impact on stress and withdrawal.
CONDITIONS
Brief Title
Effects of Cannabidiol on Stress and Nicotine Withdrawal
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 21 to 70 years
- Smoking more than 5 cigarettes daily for over 2 years
- Biological confirmation of cigarette use with expired carbon monoxide level over 8 ppm
- Alcohol use less than 2 drinks per day on average (less than 14 drinks per week)
- Normal nighttime sleep schedule, no graveyard or third shift work
- Willingness to use effective contraception during the study and for at least 30 days after last study drug if of childbearing potential
You will not qualify if you...
- Planning to reduce or quit cannabis or tobacco use within the next 30 days
- Diagnosed substance use disorder other than alcohol, cannabis, or nicotine
- Positive test for illicit drugs other than cannabis
- Positive breath alcohol test at study admission
- Current physical or mental illness or medication impacting safety or study integrity
- Resting heart rate over 100 or abnormal blood pressure outside specified ranges
- Cold intolerance or medical condition worsened by cold exposure
- Currently pregnant, planning pregnancy within 3 months, or breastfeeding
- History of significant cardiac arrhythmias or vasospastic diseases
- History or current liver disease or elevated liver enzymes beyond set limits
- Enrolled in another clinical trial or received research drug within past 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 3 weeks
Participants attend three separate experimental laboratory sessions where they receive different doses of cannabidiol (0mg, 200mg, and 400mg) during exposure to acute stress and nicotine withdrawal challenges.
3 in-person experimental laboratory sessions, each lasting approximately 5 hours and separated by at least 72 hours
Trial Site Locations
Total: 1 location
1
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
L
Lauren Brogdon, MHS
D
Dustin C. Lee, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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