University of Maryland, Baltimore
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.
This is a human laboratory systematic examination of whether adding the FDA-approved gabapentin (Neurontin; oral) to the FDA-approved opioid hydromorphone (Dilaudid; oral) will change the experience of hydromorphone as rated by laboratory measures of pain, subjective reports of drug effects, and cognitive performance. Subjects are healthy individuals with chronic lower back pain and no history of substance use disorder. Study subjects and staff are blinded to the study drugs and the class of drugs under investigation and are informed that subjects may receive opioids, stimulants, gabapentinoid…
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…
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.
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