Actively Recruiting
A Phase 2 Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants With Methamphetamine Use Disorder Not Seeking Treatment Receiving a Single Dose of Methamphetamine
Led by Clear Scientific, Inc. · Updated on 2026-01-12
40
Participants Needed
1
Research Sites
1 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
Researchers are studying the safety, effectiveness, and how the body processes four different single doses of CS-1103 in adults with methamphetamine use disorder who are not seeking treatment. The study involves giving participants a controlled dose of methamphetamine hydrochloride (30 mg IV) alongside CS-1103. This Phase 2 trial aims to better understand this treatment in otherwise healthy adults aged 18 to 55 who use methamphetamine primarily by intravenous or smoking routes. Participants are randomly assigned to receive methamphetamine HCl (30 mg) followed by either a placebo (sterile saline) or one of four doses of CS-1103, all administered through intravenous infusion. The study uses a quadruple-blind design to ensure unbiased results. The treatment period includes monitoring participants for adverse events and drug levels, with follow-up assessments extending to Day 10 after dosing. During the study, participants will undergo physical exams, ECGs, vital sign checks, and laboratory tests to monitor any side effects related to CS-1103 for three days plus a follow-up on Day 10. Researchers will also measure methamphetamine and CS-1103 concentrations in blood and urine over 48 hours. The total study participation duration includes these monitoring and follow-up periods, ensuring careful safety evaluation throughout.
CONDITIONS
Brief 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 adults aged 18 to 55 years
- Diagnosed with methamphetamine use disorder according to DSM-5 criteria
- Not currently seeking treatment for methamphetamine use disorder
- Primary method of methamphetamine use is intravenous or smoking
- Able to abstain from methamphetamine without severe withdrawal symptoms
- Body mass index between 18 and 30 kg/m2 and minimum weight of 50 kg
- Females must not be lactating and have a negative pregnancy test at screening and admission
You will not qualify if you...
- Estimated kidney function below 60 mL/min/1.73 m2
- History of cardiovascular disease
- Current moderate to severe substance use disorder for alcohol, cannabis, cocaine, opioids, or benzodiazepines
- Any other significant medical condition that may interfere with safe participation as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 hours
Participants receive a single dose of methamphetamine followed by either placebo or one of four doses of CS-1103 administered intravenously.
Daily visits for 2 days
Duration - Up to 10 days after treatment
Participants are monitored for adverse events and safety assessments including physical exams, ECGs, vital signs, and laboratory tests.
Visits on Days 3 and 10 post-treatment
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.
P
Piercen Oliver, Ph.D.
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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