Completed

NCT Number: NCT04036968

Enhancing Medication-based Analgesia in Humans- STUDY 2

This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid). This is study 2 is a series of studies.

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Key information

Conditions

Pain Agnosia Cannabis Chemically-Induced Disorders Marijuana Abuse Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid Use Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins University Bayview Medical Campus

Baltimore, Maryland, 21224, United States

About this study

This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex; oral) to the FDA-approved opioid hydromorphone (Dilaudid; oral) would change the experience of hydromorphone as rated by laboratory measures of pain, subjective reports of drug effects, and cognitive performance. Subjects are healthy individuals with no history of drug use disorder. Study subjects and staff were completed blinded to the study drugs and the class of drugs under investigation and were informed that subjects may receive opioids, stimulants, cannabinoids, benzodiazepines, over the counter medications, and/or placebo. All participants completed all sessions. Sessions lasted up to 8-hours and were conducted at least 7 days apart on an outpatient basis. Primary outcomes were collected from participants prior to dosing and at several hour periods post-dosing.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged 18-75
Urine sample tests negative for common illicit substances of abuse, including cannabis
Medically cleared to take study medications
Are not pregnant or breast feeding
Willing to comply with the study protocol.

Exclusion criteria

Meet DSM-5 criteria for alcohol/substance use disorder
Taking opioids for pain
Previous adverse reaction to a cannabinoid product
Prescribed and taking stimulants or benzodiazepines
Answer "yes" to item 1 of the Brief Pain Inventory indicating chronic pain
Self-report any illicit drug or cannabinoid use in the past 7 days
Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event
History of seizure disorder
Have a known allergy to the study medications or sesame seed oil
ALT or AST levels >3x ULN and/or Bilirubin levels >2x ULN during Screening
Current (past 60-day) suicidal thoughts or past year history of suicidal behavior
Taking medications contraindicated with hydromorphone or cannabidiol
Have a history of clinically significant cardiac arrhythmias or vasopastic disease
Have an abnormal and clinically-significant ECG

Treatment and study plan

Within-subject test of blinded study medications

Drug

Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.

Primary outcomes

Peak Cold Pressor Tolerance

Time frame: 8 hour study session

Peak amount of time participant submerged hand in cold pressor (5 degree circulating cold water) laboratory test of pain as a function of double- blinded study medications (range 0 -300).
Peak Self-report Rating of "Drug Effect" (0-100), as Measured by the Visual Analog Rating Scale

Time frame: 8 hour study session

Peak self-report rating of "Drug Effect" on a 0 ("none at all") to 100 ("extremely") visual analog scale as a function of double- blinded study medication, wherein higher values indicate stronger subjectively-experienced drug effects.
Peak Number Accurate on Circular Lights

Time frame: 8 hour study session

Peak number accuracy on the Circular Lights fine motor task as a function of double-blinded study drug administration. Participants were provided 60 seconds to press buttons that are lit in randomized order and displayed automatically on a circular lights wall mounted unit. The primary outcome is the number of lit buttons that were accurately pressed within 60 seconds, which is a metric to assess fine motor impairment. Lower numbers are indicative of greater drug-related impairment. There is no upper limit on the circular lights task.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Evaluating Cannabidiol (CBD) to Enhance the Analgesic Effect of Hydromorphone in Humans

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Jul 30, 2019
Registry last updated: Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed