Enhancing Medication-based Analgesia in Humans- STUDY 2

Johns Hopkins University

Status and phase: Completed; Phase 2

Conditions: Cannabis; Opioid Use; Pain

Treatments: Drug: Within-subject test of blinded study medications

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04036968

IRB00214289

R01DA040644 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Triple Blind

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31 participants in 5 patient groups, including a placebo group

Placebo+Placebo

Placebo Comparator group

Description:

Within-subject double-blind, double-dummy administration of placebo + placebo. Order of dose randomized session days 2-5.

Treatment:

Drug: Within-subject test of blinded study medications

Hydromorphone+Placebo

Active Comparator group

Description:

Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + placebo. Always administered during session 1.

Treatment:

Drug: Within-subject test of blinded study medications

Hydromorphone (oral) 4mg + Cannabidiol 50mg

Experimental group

Description:

Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 50mg. Order of dose randomized session days 2-5.

Treatment:

Drug: Within-subject test of blinded study medications

Hydromorphone (oral) 4mg + Cannabidiol 100mg

Experimental group

Description:

Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 100mg. Order of dose randomized session days 2-5.

Treatment:

Drug: Within-subject test of blinded study medications

Hydromorphone (oral) 4mg + Cannabidiol 200mg

Experimental group

Description:

Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 200mg. Order of dose randomized session days 2-5.

Treatment:

Drug: Within-subject test of blinded study medications