Clinical trial NCT04036968: Enhancing Medication-based Analgesia in Humans- STUDY 2
Official title: Evaluating Cannabidiol (CBD) to Enhance the Analgesic Effect of Hydromorphone in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Cannabis
Opioid Use
Keywords: Clinical Trial
Analgesia
Phase II
Abuse potential
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-07-30
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Within-subject study
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak Cold Pressor Tolerance
timeFrame: 8 hour study session
measure: Peak Self-report Rating of "Drug Effect" (0-100), as Measured by the Visual Analog Rating Scale
timeFrame: 8 hour study session
measure: Peak Number Accurate on Circular Lights
timeFrame: 8 hour study session
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University Bayview Medical Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kelly E Dunn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Claudia Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References: