Status:
RECRUITING
Effects of Cannabidiol on Stress and Nicotine Withdrawal
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
University of Minnesota
Conditions:
CBD
Stress
Eligibility:
All Genders
21-70 years
Phase:
PHASE1
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...
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 rel...
Eligibility Criteria
Inclusion
- 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).
- Sleep schedule: No graveyard or third shift work (i.e., participants must report a normal nighttime sleep schedule).
- 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
- 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
- Have a current physical or mental illness or takes a medication judged by the study team to negatively impact participant safety or scientific integrity
- Have a resting heart rate \>100, systolic blood pressure \>160mmHg or \<100mmHg, or diastolic blood pressure \>100mmHg or \<50mmHg at screening.
- Have cold intolerance or a medical condition that might be exacerbated by exposure to cold (e.g. Reynaud's, peripheral neuropathy, trigeminal neuralgia, poorly controlled/uncontrolled hypothyroidism).
- Are currently pregnant, planning to become pregnant in the next three months, or are currently breastfeeding
- Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina, Raynaud's).
- Have a history of and/or current liver disease, or elevated serum liver transaminase (AST or ALT) above 3 x Upper Limit of Normal (ULN), or elevated bilirubin above 2 x ULN at screening.
- Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.
Key Trial Info
Start Date :
August 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07001930
Start Date
August 25 2025
End Date
September 1 2029
Last Update
September 2 2025
Active Locations (1)
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1
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224