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SXC-2023 for Cocaine Use Disorder

Phase 1
Waitlist Available
Led By Debra Kelsh, MD
Research Sponsored by National Institute on Drug Abuse (NIDA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study days -2,1,2,8,9,11

Summary

This trial aims to investigate if there are any interactions between a new drug and cocaine. Participants will be divided into two groups, one receiving the new drug and the other receiving a placebo. The researchers will

Who is the study for?
This trial is for adults aged 18-59 with a history of cocaine use who are not seeking treatment for their cocaine use disorder. They must have used cocaine recently, be in good health, understand the study procedures and consent to them, and agree to use contraception if necessary. People can't join if they've had bad reactions to cocaine before or have certain health issues like liver disease or abnormal heart rates.
What is being tested?
The study is testing SXC-2023's interaction with cocaine by comparing its effects on people given either the actual drug or a placebo followed by administered cocaine. The goal is to see if there are any noticeable differences between the two groups' experiences.
What are the potential side effects?
Since this trial involves administering both a new drug (SXC-2023) and cocaine, potential side effects could include those typically associated with stimulant drugs such as increased heart rate, anxiety, restlessness, headaches, and other cardiovascular issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study days -2,1,2,8,9,11
This trial's timeline: 3 weeks for screening, Varies for treatment, and study days -2,1,2,8,9,11 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine Safety and Tolerability of Oral SXC-2023 Co-administered with Intravenous Cocaine by Collecting Vital Signs and Adverse Events

Side effects data

From 2019 Phase 2 trial • 34 Patients • NCT03887429
13%
Headache
6%
Tooth fracture
6%
Defecation Urgency
6%
Laceration
6%
Somnolence
6%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
During 200 mg SXC-2023 Treatment
During 800 mg SXC-2023 Treatment
During Placebo Treatment

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SXC-2023Experimental Treatment1 Intervention
SXC-2023: 800mg once a day for 7 days
Group II: SXC-2023 PlaceboPlacebo Group1 Intervention
Placebo: 800mg once a day for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SXC-2023
2019
Completed Phase 2
~250

Find a Location

Who is running the clinical trial?

Altasciences Company Inc.Industry Sponsor
14 Previous Clinical Trials
689 Total Patients Enrolled
Technical Resources International, Inc.UNKNOWN
1 Previous Clinical Trials
6,450 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)Lead Sponsor
2,582 Previous Clinical Trials
3,327,020 Total Patients Enrolled
~0 spots leftby Dec 2024
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