NCT02393599

Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin

Phase 1, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to determine if there are significant interactions between oral lorcaserin treatment concurrent with 20 and 40 mg intravenous (i.v.) cocaine infusions by measuring adverse events (AEs) and cardiovascular responses including heart rate (HR), blood pressure (BP), and electrocardiogram (ECG) (including QTc).

Conditions

• Cocaine Abuse

Interventions

Type	Name	Description
DRUG	Lorcaserin	10 mg 2 times per day from Day 3 to 9 and one time on Day 10
DRUG	Placebo	10 mg 2 times per day from Day 3 to 9 and one time on Day 10
DRUG	Cocaine Infusion	Screening / Session 1, Study Day -2: 20 mg cocaine, followed by a saline infusion, followed by 40 mg cocaine Baseline/ Session 2, Study Day 1: Saline or 20 mg cocaine followed by either 20 mg cocaine or saline Baseline / Session 3, Study Day 2: Saline or 40 mg cocaine followed by either 40 mg cocaine or saline Treatment / Session 4, Study Day 9: Saline or 20 mg cocaine followed by either 20 mg cocaine or saline Treatment / Session 5, Study Day10: Saline or 40 mg cocaine followed by either 40 mg cocaine or saline

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2015-03-19
• Last updated: 2017-01-11

Locations

1 site across 1 country: United States