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Mechanistic Evaluation of Polypharmacy Effects for Pain

Not yet recruitingPhase 1, Phase 2NCT07846020
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Mechanistic Evaluation of Gabapentin and Opioid Polypharmacy
Conditions
  • Chronic Lower Back Pain (CLBP)
Interventions
  • Drug: Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin)
Sponsor
University of Maryland, Baltimore
Collaborators
National Institute on Drug Abuse (NIDA)
Start date
2027-01-15
Primary completion
2032-01-15
Sex
All
Age range
from 18 Years to 65 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 18-65 years old * Lifetime history of opioid use * Medically cleared to take study medications * Chronic Lower Back Pain * Agree to use effective form of contraception throughout enrollment Exclusion Criteria: * Pregnant or breastfeeding * Have evidence of physical dependence on or current use of any central nervous system depressants including but not limited to alcohol, benzodiazepines, opioids, gabapentinoids, or barbiturates * Past 30-day use of certain pain medications * Evidence of past 7-day nonmedical drug use * Known hypersensitvity, allergy to, or history of adverse reactions to study medications * Are currently taking a medication or have a condition that is contraindicated with either study medication * Have evidence of current or past significant medical/psychiatric illness * Have a history of clinically significant cardiac arrhythmias or vasospastic disease * Have evidence of renal or hepatic impairment * Current suicidal ideation or behavior, or a history of a suicide attempt within the past 2 years * Have any condition that may increases the risk for respiratory depression

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07846020