At a glance
ClinicalIndex Comparison Record- ✓Ages 18–70 years
- ✓Meet DSM-5 criteria for opioid use disorder, at least moderate severity, but not currently seeking treatment
- ✓At least one positive urine drug screen for opioids during screening to document current opioid use
- ✓No clinically significant abnormalities in hematology and chemistry laboratory tests including liver function tests
- ✕Current DSM-5 diagnosis of any psychoactive substance use disorder other than opioids, marijuana, cocaine, or nicotine (mild-to-moderate alcohol use disorder allowed)
- ✕Current DSM-5 Axis I psychiatric disorder other than substance use disorder (e.g., bipolar disorder, major depressive disorder, ADHD, schizophrenia) or neurological disorder requiring ongoing treatment
- ✕Prior medically adverse reaction to oxycodone, other opioids, or lorcaserin
- ✕Untreated clinically significant medical disorder (cardiovascular, pulmonary, CNS, hepatic, or renal)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Drug Interaction and Subjective Effects of Compounds for Opioid Use Disorder
In Brief
A Phase 1 clinical trial evaluating Lorcaserin and Placebo for Opioid Abuse and 3 related conditions. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The overall goal of this project is to develop initial human data on effects of novel compounds on safety (interactions with oxycodone) and efficacy (subjective response to oxycodone) in non-treatment seeking opioid use disorder subjects. The compound to be studied will be the 5-HT2CR agonist lorcaserin. There are no known or reported adverse interactions between lorcaserin and oxycodone or other opioids.
Study Details
Timeline
Interventions
Lorcaserin will be administered at a dose of 10 mg twice daily for 5 days
Placebo will be administered twice daily for for 5 days