Single-dose CS-1103 to reduce effects of IV methamphetamine
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
This trial tests whether a single intravenous dose of CS-1103 is safe and can lessen the effects of a 30 mg IV methamphetamine dose in otherwise healthy adults with methamphetamine use disorder who are not seeking treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Clear Scientific, Inc. Industry-sponsored |
| Locations | 1 site (Glendale, California) |
| Trial ID | NCT06721494 on ClinicalTrials.gov |
What this trial studies
In this Phase 2, single-dose, dose-escalation study, otherwise healthy adults with DSM-5 methamphetamine use disorder receive a clinically relevant intravenous dose of methamphetamine (30 mg) together with one of four single, increasing IV doses of CS-1103 or saline. Participants are aged 18–55, are not seeking treatment for their methamphetamine use, and primarily use methamphetamine by injection or smoking. The protocol includes intensive monitoring for safety, collection of pharmacokinetic samples, and measurement of methamphetamine-related effects after dosing. The design aims to define tolerability and any acute effect reduction across ascending CS-1103 dose cohorts.
Who should consider this trial
Good fit: Adults 18–55 with DSM-5 methamphetamine use disorder who are medically healthy, not seeking treatment, and primarily use methamphetamine by injection or smoking are the intended participants.
Not a fit: People with significant cardiovascular disease, impaired kidney function, current moderate-to-severe use disorder for other substances, pregnant or lactating women, or those otherwise medically unstable are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, CS-1103 could offer a short-acting medical option to reduce the acute effects and risks of methamphetamine exposure.
How similar studies have performed: Pharmacologic options for acute methamphetamine intoxication are limited and this approach is relatively novel, with limited prior human efficacy data for CS-1103 specifically.
Eligibility criteria
Show full inclusion / exclusion criteria
Major Inclusion Criteria: 1. Healthy participants aged 18 to 55 years, inclusive; 2. Meets DSM-5 criteria for methamphetamine use disorder; 3. Not seeking treatment for methamphetamine use disorder; 4. Primary route of methamphetamine self-administration must be intravenous or smoking; 5. Able to abstain from methamphetamine without experiencing severe withdrawal; 6. A body mass index between 18 to 30 kg/m2, inclusive and a minimum body weight of 50 kg; 7. Females must not be lactating and must have a negative pregnancy test during screening and admission. Major Exclusion Criteria: 1. Estimated glomerular filtration rate \<60 mL/min/1.73 m2; 2. History of cardiovascular disease; 3. Current moderate to severe use disorder for alcohol, cannabis, cocaine, opioids, or benzodiazepines; 4. History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.
Where this trial is running
Glendale, California
- California Clinical Trials Medical Group — Glendale, California, United States (Recruiting)
Study contacts
- Principal investigator: Xinhua Li, Ph.D. — Clear Scientific, Inc.
- Study coordinator: Anna Del Rosario, B.S.
- Email: adelrosario@clearsci.com
- Phone: 617-621-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.