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Semax

ACTH(4-10) analogue, Heptapeptide SEMAX

Quick Stats
Studies 172
Trials 37
Withdrawn PHASE1 INTERVENTIONAL NCT03832816

Behavioral and Physiological Effects of THC and CBD

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This study will evaluate physiological and behavioral responses to vaporized delta9-Tetrahydrocannabinol (THC) and cannabidiol (CBD) administered via inhalation.

Detailed Description

The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). In this between-subjects study, participants will be randomized to complete 1 of 8 possible acute drug administration sessions in which participants will administer THC alone, CBD alone, THC and CBD together, or placebo. Following drug administration, participants will complete a performance session and complete a battery of questionnaires assessing subjective drug effects, mood, affect, and mental state. Vital signs and hormone levels will also be assessed before and after drug administration. The study will help the investigators understand the individual and interactive effects of THC and CBD, the two most common cannabis constituents.

Interventions

Name: Placebo
Type: DRUG
Description: Placebo vapor (distilled water)
Name: Vaporized THC alone
Type: DRUG
Description: Acute exposure to vaporized THC
Name: Vaporized CBD alone
Type: DRUG
Description: Acute exposure to vaporized CBD
Name: Vaporized CBD with THC
Type: DRUG
Description: Acute exposure to vaporized CBD with THC

Primary Outcomes

Measure: Change in blood cortisol levels
TimeFrame: Prior to drug exposure and for 4 hours post-exposure.
Description: Peak change in blood cortisol levels in micrograms per deciliter (ug/dl) will be measured
Measure: Change in blood Adrenocorticotropic hormone (ACTH) levels
TimeFrame: Prior to drug exposure and for 4 hours post-exposure.
Description: Peak change in blood ACTH levels in picograms per milliliter (pg/ml) will be measured
Measure: Change in heart rate
TimeFrame: Prior to drug exposure and for 4 hours post-exposure.
Description: Peak change in rate (in beats per minute)
Measure: Change in State Anxiety levels as assessed by the State-Trait Anxiety Inventory (STAI)
TimeFrame: Prior to drug exposure and for 4 hours post-exposure.
Description: Peak change in composite STAI score. Scale consists of 20 items assessing state anxiety levels; each item is on 4 point Likert scale ranging from 1 (not at all) to 4 (almost always). Items are summed to obtain a composite score which can range from 20 to 80 (higher scores indicate more anxiety).
Measure: Change in Mood state as assessed by the The Profile of Mood States (POMS)
TimeFrame: Prior to drug exposure and for 4 hours post-exposure.
Description: Peak change in total tension-anxiety sub-scale score for POMS. This sub-scale of the POMS consists of 9 items, each on a 4-point Likert scale ranging from 1 (not at all) to 4 (extremely) which are summed to create a total score of 9 to 36 (higher scores indicate more tension/anxiety).
Measure: Change in Positive affect levels as assessed by The Positive and Negative Affect Schedule (PANAS)
TimeFrame: Prior to drug exposure and for 4 hours post-exposure.
Description: Peak change in total positive affect score. This PANAS consists of 20 items assessing positive affect (10 items) and negative affect (10 items). Each item is on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). 10 positive affect items are summed to create a total positive affect score while the 10 negative affect items are summed to create a total negative affect score; higher total scores indicate more positive affect or more negative (i.e., worse) affect.
Measure: Change in Negative affect levels as assessed by The Positive and Negative Affect Schedule (PANAS)
TimeFrame: Prior to drug exposure and for 4 hours post-exposure.
Description: Peak change in total negative affect score. This PANAS consists of 20 items assessing positive affect (10 items) and negative affect (10 items). Each item is on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). 10 positive affect items are summed to create a total positive affect score while the 10 negative affect items are summed to create a total negative affect score; higher total scores indicate more positive affect or more negative (i.e., worse) affect.
Measure: Subjective rating of "Drug Effect" as assessed via the Drug Effect Questionnaire
TimeFrame: Prior to drug exposure and for 4 hours post-exposure.
Description: Visual Analog Scale rating of subjective drug effect. Score ranges from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.

Trial Information

NCT ID

NCT03832816

Status

Withdrawn

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Johns Hopkins University

Last Updated

December 15, 2025