Enhancing Medication-based Analgesia in Humans- STUDY 2

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036968
• Other study ID #: IRB00214289
• Secondary ID: R01DA040644
• Status: Completed
• Phase: Phase 2
• Start date: February 1, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis
• Opioid Use
• Pain

Intervention

Drug:
• Within-subject test of blinded study medications
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.

Locations

Country	Name	City	State
United States	Johns Hopkins University Bayview Medical Campus	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Cold Pressor Tolerance	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).	8 hour study session
Primary	Peak Self-report Rating of "Drug Effect" (0-100), as Measured by the Visual Analog Rating Scale	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.	8 hour study session
Primary	Peak Number Accurate on Circular Lights	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.	8 hour study session