Cannabidiol (Epidiolex) for Stress and Nicotine Withdrawal
This study is looking at how Epidiolex (an oral form of cannabidiol, or CBD) affects stress and nicotine withdrawal in people who smoke. Researchers want to see if Epidiolex can help with feelings of stress and the effects of not smoking. You might be able to join if you are a healthy adult between 21 and 70 years old, smoke more than 5 cigarettes daily, and meet other health requirements. To be eligible, you'll need a breath test showing a certain level of carbon monoxide, which confirms cigarette use. The study will measure your feelings of stress (negative and positive affect) and your blood cortisol levels (a stress hormone) at several points during the study sessions. The current recruitment status is unclear.
- Study design
- This is a double-blind, placebo-controlled study with 90 participants. This means neither you nor the researchers will know if you're receiving Epidiolex or a placebo (an inactive substance).
- What's involved
- You will have one in-person medical screening, three phone sessions, and three in-person lab sessions, each lasting about 5 hours. The total study duration is estimated to be 2-3 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your stress and cortisol levels will be measured at various time points during each 5-hour lab session.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effects of Cannabidiol on Stress and Nicotine Withdrawal
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Dustin C. Lee, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
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What this trial measures
- Negative Affect as assessed by the Subjective State Scale20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
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.
- Positive Affect as assessed by the Subjective State Scale20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
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.
- Blood Plasma Cortisol level20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
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.
- Salivary Cortisol level20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
Salivary cortisol will be collected during laboratory stress sessions using Salivette tubes and assayed using time-resolved fluorescence immunoassay.
- Plasma Concentration of Endocannabinoids20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
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.
- Heart Rate (beats per minutes)20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
Heart rate will be collected during laboratory stress testing sessions.
- Systolic Blood Pressure (mmHg)20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
Systolic blood pressure will be collected during laboratory stress testing sessions.
- Diastolic Blood Pressure (mmHg)20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
Diastolic blood pressure will be collected during laboratory stress testing sessions.