Health TrialsbyHealthPanel

Effects of Cannabidiol on Stress and Nicotine Withdrawal

ConditionsCBDStressNicotine DependenceTobacco Smoking
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-70
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 >= 5 ppm.

Alcohol Use: < 2 drinks/day on average (< 14 drinks/week).

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Epidiolex

    Drug

    Oral cannabidiol

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Ad Lib (first)Experimental treatment 1 intervention
Group B: Abstinence (first)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
2

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.

Time frame
20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
3

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.

Time frame
20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
4

Salivary Cortisol level

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

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

Secondary outcomes

1

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

Subjective pain will be measured immediately after the cold pressor task (CPT) at each stress session using the McGill Pain Questionnaire short form, with a score range of 0 to 78, with higher values indicating more significant pain.

Time frame
170 minute timepoint
2

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

Nicotine urge will be measured using the Questionnaire on Smoking Urges (QSU-brief) includes 10 items on a likert scale from 1 to 7. Total score range is 7 to 70, higher scores more nicotine urge.

Time frame
20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints
3

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

Craving for sweet and rich foods will be measured using the Questionnaire on Craving for Sweet and Rich Food, which includes one question assessing craving sweet or rich foods at the current moment, with scores ranging from 1 to 7, with higher scores indicating greater craving.

Time frame
200 minute timepoint
4

Hypothetical Tobacco Demand

Hypothetical tobacco demand will be measured using a cigarette purchase task after each laboratory stress session. Change in demand (amplitude and persistence) will be assessed to create an overall demand curve.

Time frame
200 minute timepoint

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

University of Minnesota

Collaborator

Source ClinicalTrials.gov
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