A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single… (NCT06721494) | Clinical Trial Compass
RecruitingPhase 2
A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
United States40 participantsStarted 2026-02-05
Plain-language summary
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).
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 self-administration must be intravenous or smoking;
. Able to abstain from methamphetamine without experiencing severe withdrawal;
. A body mass index between 18 to 30 kg/m2, inclusive and a minimum body weight of 56 kg;
. Females must not be lactating and must have a negative pregnancy test during screening and admission.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations
Timeframe: 3 days plus follow-up on Day 10
2
Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs)
Timeframe: 3 days plus follow-up on Day 10
3
Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs
Timeframe: 3 days plus follow-up on Day 10
4
Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters
Timeframe: 3 days plus follow-up on Day 10
5
Time course and magnitude of urine excretion of methamphetamine