Repeated CBD Administration and Cannabis Outcomes
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHannah Harris
About this trial
This outpatient study examines how cannabidiol (CBD) affects the behavioral and pain-relieving effects of cannabis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
English-speaking, literate adults,
Male or female,
Between the ages of 18-55,
Body Mass Index from 18.5-32.0 kg/m2,
Disqualifiers
Physiologic drug dependence on opioids, benzodiazepines, barbiturates, and/or alcohol that would require medical management,
Clinically significant acute medical problem (e.g., infection) or chronic medical problem requiring daily medication or ongoing medical care (e.g., hypertension, cardiovascular disease, diabetes, respiratory disorders [e.g., asthma, COPD]),
Current or past history of major psychiatric disorder that would limit ability to participate in the study,
Use of cannabis exclusively for medical reasons (no recreational use reported),
Trial design
Design model
Crossover
Treatments tested in this trial
Cannabidiol, Medium Dose
DrugActive Cannabidiol: Active cannabidiol (medium dose) will be administered orally for 14 days.
Cannabidiol, Higher Dose
DrugDescription: Active Cannabidiol: Active cannabidiol (higher dose) will be administered orally for 14 days.
Active Inhaled Cannabis
DrugActive Marijuana: Active Marijuana (active inhaled cannabis) will be administered through a vaporizer once per study session day (Day 1, 7, 14) per block (3 blocks total).
Placebo Cannabidiol
DrugInactive/Placebo Cannabidiol: Inactive/placebo cannabidiol will be administered orally for 14 days.
Placebo Inhaled Cannabis
DrugInactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer at each study session day (Days 1, 7, 14) per block (3 blocks total).
Treatment groups
23 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Placebo CBD/Placebo Inhaled CannabisPlacebo comparator 2 interventions
Group B: Placebo CBD/Active Inhaled CannabisExperimental treatment 2 interventions
Group C: CBD (Medium Dose)/Placebo Inhaled CannabisExperimental treatment 2 interventions
Group D: CBD (Medium Dose)/Active Inhaled CannabisExperimental treatment 2 interventions
Group E: CBD (Higher Dose)/Placebo Inhaled CannabisExperimental treatment 2 interventions
Group F: CBD (Higher Dose)/Active Inhaled CannabisExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change from Baseline-Subject-Related Outcome-VAS Drug Liking
Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). These Scores will indicate how participants are feeling at that moment, including questions on mood, physical symptoms, and drug effects. Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores.
Time frame
Days 1 (baseline), 7, 14, prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).2
Change from Baseline-Marijuana Purchase Task: Elasticity
Behavioral economic demand for cannabis: how much a participant values cannabis as its "price" (cost, effort, or availability) increases. Participants indicate how much marijuana they would buy and consume at increasing, hypothetical prices. This outcome describes how sensitive marijuana consumption is to price changes and how quickly demand decreases as marijuana becomes more expensive.
Time frame
Days 1 (baseline), 7, 14, measured ~3 hours post cannabis administration.Secondary outcomes
1
Change from Baseline-Cold Pressor Test (CPT) Threshold
Participants first immerse a dominant hand into the warm-water bath for 2 minutes. The participants are then instructed to immerse the dominanat hand in the cold-water bath and report when pain is first experienced, and to keep the hand submerged as long as possible, and to withdraw the hand from the water when the sensation becomes uncomfortable. Latency (in seconds) to first pain sensations (threshold) will be measured and recorded.
Time frame
Days 1 (baseline), 7, 14, This outcome will be recorded before and at two additional intervals after active and placebo cannabis administration during the laboratory session (a total of 6 measurements per session).2
Change from Baseline-Cold Pressor Test (CPT) Tolerance
Participants first immerse a dominant hand into the warm-water bath for 2 minutes. The participants are then instructed to immerse the dominant hand in the cold-water bath and report when pain is first experienced, and to keep the hand submerged as long as possible, and to withdraw the hand from the water when the sensation becomes uncomfortable. Latency to withdrawal from the water (tolerance) will be measured and recorded.
Time frame
Days 1 (baseline), 7, 14, This outcome will be recorded before and at two additional intervals after active and placebo cannabis administration during the laboratory session (a total of 6 measurements per session).3
Change from Baseline-Cold Pressor Visual Analog Scale (CPT-VAS): Painful
Participants first immerse a dominant hand in the warm-water bath for 2 minutes. The participants are then instructed to immerse the dominant hand in the cold-water bath and report when pain is first experienced, and to keep the hand submerged as long as possible, and to withdraw the hand from the water when the sensation becomes uncomfortable. Participants will report how painful the pain was on a visual analog scale. Low scores mean little to no pain. Higher scores mean greater pain. Raw data transformed to peak scores.
Time frame
Days 1 (baseline), 7, 14, This outcome will be recorded before and after the CPT for a total of 6 measurements per session.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hannah Harris
Lead sponsor
University of Kentucky
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov