Enhancing Medication-based Analgesia in Humans

NCT02901275 | Completed Phase 2 Results DMC

• 1 other identifier: IRB00097937
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid dronabinol (Marinol) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid).

Conditions

Pain; Cannabis; Opioid Use, Unspecified

Keywords

Clinical Trial, Phase II; Analgesia; Abuse Potential

Outcome Measures

Primary Outcomes (3)

• Mean Change From Baseline in Seconds to Withdraw Hand From Cold Pressor Laboratory Pain Task

  Compare study conditions in seconds to withdraw hand from cold pressor laboratory pain task, where longer time periods reflect higher tolerance to pain.

  Baseline and time of hand withdrawal from cold pressor, up to 60 seconds

• Mean Peak Rating of "Drug Effect" (0-100) as Measured by the Visual Analog Rating Scale

  Mean peak of Visual Analog Scale ratings of Drug Effect (0-100) compared across each study condition, with higher ratings reflecting stronger drug effects.

  8-hour study session

• Mean Change From Baseline in Maximum Percent Correct on Digit Symbol Substitution Test of Cognitive Behavior

  Within-subject comparison of study conditions on the Digit Symbol Substitution Test (DSST), a measure of cognitive performance that is sensitive to drug effects, wherein lower percent scores reflect worse performance and suggest greater drug-related impairment.

  Baseline and 8-hours

Study Arms (5)

Placebo + Placebo

PLACEBO COMPARATOR

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

Drug: Within-subject test of blinded study medications

Hydromorphone (oral) 4mg + Placebo

ACTIVE COMPARATOR

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

Drug: Within-subject test of blinded study medications

Hydromorphone (oral) 4mg / Dronabinol (oral) 2.5mg

EXPERIMENTAL

Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + dronabinol (oral) 2.5mg. Order of dose randomized session days 2-5.

Drug: Within-subject test of blinded study medications

Hydromorphone (oral) 4mg / Dronabinol (oral) 5mg

EXPERIMENTAL

Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + dronabinol (oral) 5.0mg. Order of dose randomized session days 2-5.

Drug: Within-subject test of blinded study medications

Hydromorphone (oral) 4mg / Dronabinol (oral) 10mg

EXPERIMENTAL

Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + dronabinol (oral) 10mg. Order of dose randomized session days 2-5 but was never the first hydromorphone 4mg + dronabinol combination dose.

Drug: Within-subject test of blinded study medications

Interventions

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.

Hydromorphone (oral) 4mg + Placebo; Hydromorphone (oral) 4mg / Dronabinol (oral) 10mg; Hydromorphone (oral) 4mg / Dronabinol (oral) 2.5mg; Hydromorphone (oral) 4mg / Dronabinol (oral) 5mg; Placebo + Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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
• Taking medications contraindicated with hydromorphone or dronabinol
• Have a history of clinically significant cardiac arrhythmias or vasopastic disease
• Have an abnormal and clinically-significant ECG

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Pain; Marijuana Abuse; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Dr. Kelly Dunn
• Organization: Johns Hopkins University School of Medicine

kdunn9@jhmi.edu

410-550-2254

Study Officials

• Kelly Dunn, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

• Claudia Campbell, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant completed each of the 5 study conditions (identified here as arms).

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: September 15, 2016
• Study Start: December 1, 2016
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: November 7, 2023
• Results First Posted: June 7, 2021

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)