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