Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-03-06 @ 7:46 AM
Study NCT ID:
NCT06343532
Status:
COMPLETED
Last Update Posted:
2025-05-20
First Post:
2024-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SXC-2023 Cocaine Interaction Study
Sponsor:
National Institute on Drug Abuse (NIDA)
Organization:
Study Overview
Official Title:
Phase 1, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess Potential Interactions Between Intravenous Cocaine and Oral SXC-2023
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: