Enhancing Medication-based Analgesia in Humans

Johns Hopkins University29 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Pain Cannabis Opioid Use, Unspecified

Interventions

Within-subject test of blinded study medicationsDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and 8-hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.