Mechanistic Evaluation of Polypharmacy Effects for Pain
ConditionChronic Lower Back Pain (CLBP)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Maryland, Baltimore
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-65 years old
Lifetime history of opioid use
Medically cleared to take study medications
Chronic Lower Back Pain
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Within-subject test of blinded study medications (Placebo, Hydromorphone, Gabapentin)
DrugWithin-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.
Treatment groups
110 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Placebo hydromorphone, Placebo gabapentinPlacebo comparator 1 intervention
Group B: Active hydromorphone, Low dose gabapentinExperimental treatment 1 intervention
Group C: Active hydromorphone, High dose gabapentinExperimental treatment 1 intervention
Group D: Placebo hydromorphone, Low dose gabapentinActive comparator 1 intervention
Group E: Placebo hydromorphone, High dose gabapentinActive comparator 1 intervention
Group F: Active hydromorphone, placebo gabapentinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Peak change from baseline Drug Effect
Peak self-reported "Drug Effect" on a visual analogue scale (0-100) minus baseline ratings of self-reported "Drug Effect" on a visual anaogue scale (0-100)
Time frame
8 hour study sessions2
Peak change from baseline Good Effect
Peak self-reported "Good Effect" on a visual analogue scale (0-100) minus baseline ratings of self-reported "Good Effect" on a visual anaogue scale (0-100), where lower scores indicate no effect and greater scores indicate maximum effect.
Time frame
Baseline (0.5 hours before drug administration) and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 8 hours after drug administration3
Peak Cold Pressor Test Tolerance change from baseline score
Peak Cold Pressor Test Tolerance Score minus baseline Peak Cold Pressor Test Tolerance score. Outcome ranges from 0-60 seconds, 0 indicating low analgesic effect and 60 indicating high analgesic effects.
Time frame
Baseline (0.5 hours before drug administration) and 4 and 6 hours after study drug administration4
Peak Cold Pressor Test Threshold change from baseline score
Peak Cold Pressor Test Threshold Score minus baseline Peak Cold Pressor Test Threshold score. Outcome ranges from 0-60 seconds, 0 indicating low analgesic effect and 60 indicating high analgesic effects.
Time frame
Baseline (0.5 hours before drug administration) and 4 and 6 hours after study drug administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Maryland, Baltimore
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov
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