Actively Recruiting
A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
Led by Clear Scientific, Inc. · Updated on 2026-01-12
40
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
Sponsors
C
Clear Scientific, Inc.
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate the safety, efficacy, and pharmacokinetics of four single, increasing doses of CS-1103, given by intravenous (IV) infusion in otherwise healthy, non-treatment seeking participants with methamphetamine use disorder in the presence of a clinically relevant dose of methamphetamine HCl (30 mg IV).
CONDITIONS
Official Title
A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy participants aged 18 to 55 years, inclusive
- Meets DSM-5 criteria for methamphetamine use disorder
- Not seeking treatment for methamphetamine use disorder
- Primary route of methamphetamine use must be intravenous or smoking
- Able to abstain from methamphetamine without severe withdrawal
- Body mass index between 18 to 30 kg/m2 and minimum body weight of 50 kg
- Females must not be lactating and must have a negative pregnancy test at screening and admission
You will not qualify if you...
- Estimated glomerular filtration rate less than 60 mL/min/1.73 m2
- History of cardiovascular disease
- Current moderate to severe use disorder for alcohol, cannabis, cocaine, opioids, or benzodiazepines
- Any clinically important disease or disorder that may interfere with safe participation, as judged by the Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
California Clinical Trials Medical Group
Glendale, California, United States, 91206
Actively Recruiting
Research Team
A
Anna Del Rosario, B.S.
CONTACT
P
Piercen Oliver, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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