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Mechanistic Evaluation of Polypharmacy Effects for Pain
Sponsor: University of Maryland, Baltimore
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
Conditions
Interventions
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