NCT06343532

SXC-2023 Cocaine Interaction Study

Phase 1, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess Potential Interactions Between Intravenous Cocaine and Oral SXC-2023

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to determine whether there are any interactions between the study drug and cocaine. Researchers will compare a treatment group and a placebo group to see if they experience any effects when administered cocaine after taking the treatment/placebo.

Detailed description

This is a double-blind, placebo-controlled, parallel group study to compare the effects of SXC-2023 versus placebo control on intravenous cocaine's physiological and subjective effects in non-treatment seeking cocaine-experienced volunteers. Participants will be 18 to 59 years of age who have used cocaine by the smoked or intravenous route at least 6 times in the past 12 months prior to clinic intake, with at least one use within the past 3 months. Approximately twenty participants will be randomized to 2 groups, receiving either SXC-2023 or placebo treatment for 7 days. Adverse events and cardiovascular responses will be measured.

Conditions

• Cocaine Use Disorder

Interventions

Type	Name	Description
DRUG	SXC-2023	200 mg capsules
DRUG	SXC-2023 Placebo	200 mg capsules

Timeline

• Start date: 2024-10-11
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2024-04-02
• Last updated: 2025-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study