Actively Recruiting

Phase 1
Age: 21Years - 70Years
All Genders
NCT07001930

Effects of Cannabidiol on Stress and Nicotine Withdrawal

Led by Johns Hopkins University · Updated on 2025-09-02

90

Participants Needed

1

Research Sites

209 weeks

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

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.

CONDITIONS

Official Title

Effects of Cannabidiol on Stress and Nicotine Withdrawal

Who Can Participate

Age: 21Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adults aged 21 to 70 years inclusive
  • Use more than 5 cigarettes per day for over 2 years
  • Confirm cigarette use with expired carbon monoxide level over 8 ppm
  • Consume less than 2 alcoholic drinks per day on average (less than 14 drinks per week)
  • Maintain a normal nighttime sleep schedule without graveyard or third shift work
  • Willingness to use effective contraception during the study and for 30 days after last dose if applicable
Not Eligible

You will not qualify if you...

  • Intention to reduce or quit cannabis or tobacco use within the next 30 days
  • Diagnosis of substance use disorder (other than alcohol, cannabis, or nicotine) according to DSM-5
  • Positive test for illicit drugs other than cannabis
  • Positive breath alcohol test above 0.01 g/210L at study admission
  • Current physical or mental illness or medication affecting safety or study integrity
  • Resting heart rate over 100 bpm, systolic blood pressure over 160 mmHg or under 100 mmHg, or diastolic blood pressure over 100 mmHg or under 50 mmHg
  • Cold intolerance or medical conditions worsened by cold exposure
  • Current pregnancy, planning pregnancy within 3 months, or breastfeeding
  • History or current significant cardiac arrhythmias or vasospastic disease
  • History of or current liver disease or elevated liver enzymes above specified limits
  • Participation in another clinical trial or receipt of study drug within 30 days prior to enrollment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States, 21224

Actively Recruiting

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Research Team

L

Lauren Brogdon, MHS

CONTACT

D

Dustin C. Lee, PhD

CONTACT

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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