NCT06721494 A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
| NCT ID | NCT06721494 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Clear Scientific, Inc. |
| Condition | Methamphetamine Intoxication |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-02-05 |
| Primary Completion | 2026-09-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2026-02-05 with a primary completion date of 2026-09-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility 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 56 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.
Contact & Investigator
Xinhua Li, Ph.D.
PRINCIPAL INVESTIGATOR
Clear Scientific, Inc.
Frequently Asked Questions
Who can join the NCT06721494 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Methamphetamine Intoxication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06721494 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06721494 currently recruiting?
Yes, NCT06721494 is actively recruiting participants. Contact the research team at adelrosario@clearsci.com for enrollment information.
Where is the NCT06721494 trial being conducted?
This trial is being conducted at Glendale, United States.
Who is sponsoring the NCT06721494 clinical trial?
NCT06721494 is sponsored by Clear Scientific, Inc.. The principal investigator is Xinhua Li, Ph.D. at Clear Scientific, Inc.. The trial plans to enroll 40 participants.