Effects of Cannabidiol on Stress and Nicotine Withdrawal

NCT07001930 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IRB00440948R01DA027232-09A1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

CBD; Stress; Nicotine Dependence; Tobacco Smoking

Keywords

CBD; Stress; Nicotine; Tobacco Smoking

Outcome Measures

Primary Outcomes (8)

• Negative Affect as assessed by the Subjective State Scale

  Negative affect is measured using the Subjective State Scale which includes 4 items measuring negative affect. The scale has a range of 0 to 28 with higher scores indicating greater negative affect.

  20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

• Positive Affect as assessed by the Subjective State Scale

  Positive affect is measured using the Subjective State Scale which includes 5 items measuring positive affect. The scale has a range of 0 to 35 with higher scores indicating greater positive affect.

  20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

• Blood Plasma Cortisol level

  Blood plasma cortisol will be collected during laboratory stress testing sessions using a 20-gauge IV Teflon catheter inserted in a non-dominant forearm vein.

  20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

• Salivary Cortisol level

  Salivary cortisol will be collected during laboratory stress sessions using Salivette tubes and assayed using time-resolved fluorescence immunoassay.

  20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

• Plasma Concentration of Endocannabinoids

  Blood plasma endocannabinoids will be collected during laboratory stress testing sessions using a 20-gauge IV Teflon catheter inserted in a non-dominant forearm vein.

  20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

• Heart Rate (beats per minutes)

  Heart rate will be collected during laboratory stress testing sessions.

  20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

• Systolic Blood Pressure (mmHg)

  Systolic blood pressure will be collected during laboratory stress testing sessions.

  20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

• Diastolic Blood Pressure (mmHg)

  Diastolic blood pressure will be collected during laboratory stress testing sessions.

  20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

Secondary Outcomes (6)

• Subjective Pain as assessed by the McGill Pain Questionnaire short form (MPQ)

  170 minute timepoint

• Nicotine urge as assessed by the Questionnaire on Smoking Urges (QSU-brief)

  20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

• Craving for Sweet and Rich Foods as assessed by the Questionnaire on Craving for Sweet and Rich Food,

  200 minute timepoint

• Hypothetical Tobacco Demand

  200 minute timepoint

• Sustained Attention to Response Task

  200 minute timepoint

Study Arms (2)

Ad Lib (first)

EXPERIMENTAL

Participants who use tobacco cigarettes and will be randomly assigned to smoking ab lib. Each participant will receive 0, 200, 400 mg of CBD in this arm.

Drug: Epidiolex

Abstinence (first)

EXPERIMENTAL

Participants who use tobacco cigarettes and will be randomly assigned to smoking abstinence for 24 hours before each session. Each participant will receive 0, 200, 400 mg of CBD in this arm.

Drug: Epidiolex

Interventions

Epidiolex DRUG

Oral cannabidiol

Abstinence (first); Ad Lib (first)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Minnesota: collaborator

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Smoking

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Dustin C. Lee, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Brogdon, MHS

CONTACT

410-550-6953; lmorri20@jhmi.edu

Dustin C. Lee, PhD

CONTACT

410-550-4035; dlee@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double-blind, placebo-controlled, within-subjects crossover design

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 3, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)