NCT03143855

Drug Interaction and Subjective Effects of Compounds for Opioid Use Disorder

Phase I Drug Interaction and Subjective Effects of Compounds for Opioid Use Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Lorcaserin is a serotonin (5-HT) 2C receptor agonist (Trade Name Belviq) approved for treatment of obesity. The study teams's preclinical research collaborators and others have shown that lorcaserin and other 5-HT2CR agonists have been shown to reduce drugs of abuse self-administration and cue reactivity in rodents including cocaine and nicotine. Recently, this data has been expanded to opioids. Rats trained to self-administer oxycodone showed a significant reduction in self-administration and oxycodone cue induced lever presses after lorcaserin administration. This is a single center, double-blind, placebo-controlled, randomized, 1b/2a study. 18 subjects are planned. The following treatment regimens will be used: Lorcaserin will be administered at a dose of 10mg twice daily. Placebo or Comparator - identical placebo capsules administered at the same time as lorcaserin.

Conditions

• Opioid Abuse
• Opioid Dependence
• Opioid-Related Disorders
• Opioid Use

Interventions

Type	Name	Description
DRUG	Lorcaserin	Lorcaserin will be administered at a dose of 10 mg twice daily for 5 days
DRUG	Placebo	Placebo will be administered twice daily for for 5 days

Timeline

• Start date: 2017-01-30
• Primary completion: 2019-04-05
• Completion: 2019-04-05
• First posted: 2017-05-08
• Last updated: 2020-11-12
• Results posted: 2020-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study