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NOT YET RECRUITING
NCT07846020
PHASE1/PHASE2

Mechanistic Evaluation of Polypharmacy Effects for Pain

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

Summary

This is a single-group, within-subject, double-blind, double-dummy, placebo-controlled study evaluating whether gabapentin (Neurontin) changes the analgesic, safety, and subjective effects of the opioid hydromorphone (Dilaudid) when the two are combined.

Official title: Mechanistic Evaluation of Gabapentin and Opioid Polypharmacy

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2027-01-15

Completion Date

2032-04-01

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

DRUG

Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin)

Within-subject double-blind, double-dummy, study design wherein all participants received all drug combinations (Placebo + Placebo, Hydromorphone + Placebo, Low Dose Gabapentin + Placebo, High Dose Gabapentin + Placebo, Low Dose Gabapentin + Hydromorphone, High Dose Gabapentin + Hydromorphone) 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 (1)

Kahlert Institute for Addiction Medicine

Baltimore, Maryland, United States