Enhancing Medication-based Analgesia in Humans

Pain Clinical Trial

Official title:

Using Dronabinol to Enhance the Analgesic Effect of Hydromorphone in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901275
• Other study ID #: IRB00097937
• Status: Completed
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: March 23, 2020

Study information

• Verified date: November 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 dronabinol (Marinol) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid).

Description:

This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid dronabinol (Marinol; 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: 29
• Est. completion date: March 23, 2020
• Est. primary completion date: March 23, 2020
• 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 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

Related Conditions & MeSH terms

• Cannabis
• Opioid Use, Unspecified
• 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	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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