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Gabapentin + Hydromorphone for Chronic Lower Back Pain

(PAT Trial)

SD
Overseen BySarah Dowell
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Maryland, Baltimore

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults with chronic lower back pain. Participants should not have conditions or take medications that could interfere with the study drugs, and must be able to safely stop other pain medicines as required by the researchers.

Inclusion Criteria

Lifetime history of opioid use
Agree to use effective form of contraception throughout enrollment
I have chronic lower back pain.
See 2 more

Exclusion Criteria

Have any condition that may increase the risk for respiratory depression
Have evidence of current or past significant medical/psychiatric illness
Current suicidal ideation or behavior, or a history of a suicide attempt within the past 2 years
See 8 more

What Are the Treatments Tested in This Trial?

Interventions

  • Gabapentin
  • Hydromorphone

Trial Overview

The study tests how gabapentin affects the pain relief and side effects of hydromorphone when used together, compared to each drug alone and placebo. Each participant tries all treatments in a blinded, controlled setting.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Active hydromorphone, Low dose gabapentinExperimental Treatment1 Intervention
Group II: Active hydromorphone, High dose gabapentinExperimental Treatment1 Intervention
Group III: Placebo hydromorphone, Low dose gabapentinActive Control1 Intervention
Group IV: Placebo hydromorphone, High dose gabapentinActive Control1 Intervention
Group V: Active hydromorphone, placebo gabapentinActive Control1 Intervention
Group VI: Placebo hydromorphone, Placebo gabapentinPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials
729
Recruited
540,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

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