Abuse Liability, Cannabis, Experimental Pain in Healthy Human Participants
Conditions
Keywords
marijuana, cannabidiol (CBD), marijuana users
Brief summary
This outpatient study examines how cannabidiol (CBD) affects the behavioral and pain-relieving effects of cannabis.
Interventions
DRUGCannabidiol, Medium Dose
Active Cannabidiol: Active cannabidiol (medium dose) will be administered orally for 14 days.
DRUGCannabidiol, Higher Dose
Description: Active Cannabidiol: Active cannabidiol (higher dose) will be administered orally for 14 days.
Active 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).
Inactive/Placebo Cannabidiol: Inactive/placebo cannabidiol will be administered orally for 14 days.
DRUGPlacebo Inhaled Cannabis
Inactive/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).
Sponsors
Hannah Harris
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* English-speaking, literate adults, * Male or female, * Between the ages of 18-55, * Body Mass Index from 18.5-32.0 kg/m2, * Not currently seeking treatment for cannabis or drug use, * Able to provide written informed consent and perform all study procedures, * If female, a negative pregnancy test and use of an effective form of contraception during study participation (e.g., oral contraceptive, abstinence, barrier method), * Negative urine drug test for drugs of abuse (other than cannabis) prior to every Laboratory Session, and * Otherwise healthy as determined by the investigator based on medical history, physical examination, vital signs, and laboratory chemistries.
Exclusion criteria
* 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), * Current, unrelenting chronic pain that prevents participation (i.e., unable to sit in chair for 8 hours), * Currently using daily prescription medications to manage medical conditions or any drug that could interfere with the study, including potent CYP2C9, CYP3A4, or CYP2C19 inducers, * Clinically significant abnormal ECG (as determined by study physician/cardiologist), * Clinically significant abnormal laboratory findings, * History of seizure disorder, * Clinically significant history of head injuries requiring medical management or long lasting sequalae, and * Self-report of past 30-day use of synthetic cannabis (i.e., K2, Spice).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline-Subject-Related Outcome-VAS Drug Liking | 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). | 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. |
| Change from Baseline-Marijuana Purchase Task: Elasticity | Days 1 (baseline), 7, 14, measured ~3 hours post cannabis administration. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline-Cold Pressor Test (CPT) Threshold | 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). | 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. |
| Change from Baseline-Cold Pressor Test (CPT) Tolerance | 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). | 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. |
| Change from Baseline-Cold Pressor Visual Analog Scale (CPT-VAS): Painful | Days 1 (baseline), 7, 14, This outcome will be recorded before and after the CPT for a total of 6 measurements per session. | 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. |
Countries
United States
Contacts
CONTACTPaul A Nuzzo, M.A.
PRINCIPAL_INVESTIGATORHannah M Harris, Ph.D.
University of Kentucky
Outcome results
None listed