Methamphetamine IntoxicationPhase 2NCT06721494
A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
A Phase 2 study testing Methamphetamine, Sterile Saline and CS-1103 in people with Methamphetamine Intoxication and Methamphetamine Disorders, run by Clear Scientific, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Methamphetamine Intoxication, Methamphetamine Disorders, Methamphetamine Abuse
- What is being tested?
- Methamphetamine, Sterile Saline and CS-1103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2026to 5 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Major 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.
Major Exclusion Criteria:
- Estimated glomerular filtration rate <60 mL/min/1.73 m2;
- History of cardiovascular disease;
- Current moderate to severe use disorder for alcohol, cannabis, cocaine, opioids, or benzodiazepines;
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
California Clinical Trials Medical Group
Glendale, California, 91206
Lev Gertsik, M.D., 888-228-7425, study.losangeles@parexel.com
About this study
Official title: 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
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).
- Being tested
- Methamphetamine, Sterile Saline, CS-1103
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethamphetamineDrug
Methamphetamine HCl for intravenous administration
Sterile SalineDrug
Sterile Saline for intravenous administration
CS-1103Drug
CS-1103 for intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants receive methamphetamine HCl (30 mg) followed by placebo (saline). Receives: Drug: Methamphetamine; Drug: Sterile Saline |
| Active | Active comparator | Participants receive methamphetamine HCl (30 mg) followed by one of four doses of CS-1103 Receives: Drug: Methamphetamine; Drug: CS-1103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations
Physical examinations
Measured: 3 days plus follow-up on Day 10
Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs)
Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted.
Measured: 3 days plus follow-up on Day 10
Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs
Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature
Measured: 3 days plus follow-up on Day 10
Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters
Clinical chemistry, hematology, coagulation, and urinalysis
Measured: 3 days plus follow-up on Day 10
Time course and magnitude of urine excretion of methamphetamine
Measurement of concentration of methamphetamine in urine
Measured: 48 hours
Secondary outcomes (1)
Time course of CS-1103 blood and urine concentrations
Measurement of plasma and urine concentrations of CS-1103
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start5 Feb 2026
- Primary completion29 Oct 2026 (estimated)
- Study completion5 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine IntoxicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clear Scientific, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Xinhua Li, Ph.D., Principal investigator, Clear Scientific, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721494
- Sponsor's protocol ID
- CS-1103-02
- Other IDs
- 5U01DA058548-02
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06721494
- Acronym / sponsor ID
- CS-1103-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Clear Scientific, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 29 Oct 2026 (estimated)
- Study completion
- 5 Nov 2026 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Methamphetamine, Drug: Sterile SalineParticipants receive methamphetamine HCl (30 mg) followed by placebo (saline). |
| Active | Active comparator | Drug: Methamphetamine, Drug: CS-1103Participants receive methamphetamine HCl (30 mg) followed by one of four doses of CS-1103 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethamphetamineMethamphetamine HCl for intravenous administration | Drug | Active, Placebo |
| Sterile SalineSterile Saline for intravenous administration | Drug | Placebo |
| CS-1103CS-1103 for intravenous administration | Drug | Active |
Primary outcome
Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations
Time frame: 3 days plus follow-up on Day 10
Physical examinations
Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs)
Time frame: 3 days plus follow-up on Day 10
Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted.
Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs
Time frame: 3 days plus follow-up on Day 10
Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature
Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters
Time frame: 3 days plus follow-up on Day 10
Clinical chemistry, hematology, coagulation, and urinalysis
Time course and magnitude of urine excretion of methamphetamine
Time frame: 48 hours
Measurement of concentration of methamphetamine in urine
1 secondary outcome
Time course of CS-1103 blood and urine concentrations
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinhua Li, Ph.D. principal investigator
Clear Scientific, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methamphetamine, Sterile Saline and CS-1103 in people with Methamphetamine Intoxication and Methamphetamine Disorders, run by Clear Scientific, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Del Rosario, B.S. (617-621-8500, adelrosario@clearsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations (time frame: 3 days plus follow-up on Day 10). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.