CS-1103 for Methamphetamine Abuse

Overseen By Piercen Oliver, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Clear Scientific, Inc.

Disqualifiers: Cardiovascular disease, Alcohol use disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CS-1103, a potential drug for methamphetamine use disorder. Researchers aim to assess the safety and effectiveness of different doses of CS-1103 when combined with methamphetamine. Participants will receive either a placebo (a harmless substance) or one of four doses of CS-1103 after methamphetamine administration. The trial seeks healthy individuals with methamphetamine use disorder who are not currently seeking treatment, particularly those who typically use methamphetamine by injection or smoking. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the development of a potentially effective treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that CS-1103 is likely to be safe for humans?

Research has shown that CS-1103 has promising safety results from earlier studies. In tests where participants took a single dose, the treatment was well tolerated, and no serious side effects occurred. This suggests that CS-1103 could be safe at doses expected to help with methamphetamine problems. The FDA is fast-tracking the drug due to its potential benefits. So far, results indicate that CS-1103 might be a safe option for those with methamphetamine use disorder. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about CS-1103 for methamphetamine abuse because it offers a novel approach compared to existing treatments like behavioral therapy and medications such as bupropion and naltrexone. Unlike these treatments, which primarily focus on managing withdrawal symptoms or reducing cravings through traditional pathways, CS-1103 targets methamphetamine's effects directly by potentially interfering with the drug's impact on the brain. This new mechanism may provide a more effective solution for reducing methamphetamine use and improving recovery outcomes.

What evidence suggests that CS-1103 might be an effective treatment for methamphetamine use disorder?

Research has shown that CS-1103 might help treat methamphetamine abuse. Early studies found that CS-1103 attaches to methamphetamine in the blood, aiding its removal from the body through urine. This process could quickly reduce the drug's harmful effects. Previous research also suggests that CS-1103 is safe, with no serious side effects observed in early tests. In this trial, participants will receive either a placebo or one of four doses of CS-1103 to evaluate its effectiveness. Overall, these studies indicate that CS-1103 could be a promising treatment for methamphetamine overdose. ^{1 2 3 6 7}

Who Is on the Research Team?

Xinhua Li, Ph.D.

Principal Investigator

Clear Scientific, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-55 with methamphetamine use disorder who primarily use it intravenously or by smoking. They must not be seeking treatment, able to avoid withdrawal symptoms without using, and have a BMI of 18-30 kg/m2. Women can't be pregnant or lactating.

Inclusion Criteria

Not seeking treatment for methamphetamine use disorder

Meets DSM-5 criteria for methamphetamine use disorder

Able to abstain from methamphetamine without experiencing severe withdrawal

Exclusion Criteria

Estimated glomerular filtration rate <60 mL/min/1.73 m2

I have a history of heart disease.

Current moderate to severe use disorder for alcohol, cannabis, cocaine, opioids, or benzodiazepines

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive methamphetamine HCl (30 mg) followed by either placebo or one of four doses of CS-1103

3 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events and pharmacokinetics

7 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CS-1103

Trial Overview The study tests the safety and effectiveness of CS-1103 in participants given a dose of methamphetamine. It involves four increasing doses of CS-1103 administered via IV alongside a fixed dose of methamphetamine to see how the body reacts.

How Is the Trial Designed?

Group I: Active Active Control 2 Interventions

Participants receive methamphetamine HCl (30 mg) followed by one of four doses of CS-1103

Group II: Placebo Placebo Group 2 Interventions

Participants receive methamphetamine HCl (30 mg) followed by placebo (saline).

Who Is Running the Clinical Trial?

Clear Scientific, Inc.

Lead Sponsor

Trials

2

Recruited

70+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10156784

CS-1103 Expected outcome is that CS-1103 will be safe at doses anticipated to be effective for reversal of acute methamphetamine intoxication. Public Health Relevance ...

2. empr.com empr.com/news/fda-fast-tracks-treatment-for-acute-methamphetamine-intoxication/

FDA Fast Tracks Treatment for Acute Methamphetamine ... Single doses of CS-1103 were well tolerated, with no serious adverse events reported. CS-1103 will also be evaluated in a phase 2 trial ( ...

3. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.pn.2025.11.11.1

MedCheck: LSD Reduced Anxiety, Meth Intoxication ... In preclinical trials, CS-1103 has been shown to bind and encapsulate intoxicants in the blood to rapidly reverse their toxic effects and ...

4. highergov.com highergov.com/grant/U01DA058548/

Rapid Reversal of Meth Intoxication CS-1103 selectively binds METH in blood and dramatically accelerates its removal from the body by clearance into the urine, representing a new approach to the ...

5. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=U01DA058548&arg_ProgOfficeCode=114

Award Information | HHS TAGGS ... CS-1103 is to lower the level of methamphetamine in the human body. CS-1103 is 10 well-tolerated in rodent and canine and is highly effective in lowering ...

6. synapse.patsnap.com synapse.patsnap.com/blog/initial-positive-clinical-trial-results-for-cs-1103-a-novel-treatment-for-meth-and-fentanyl-overdose

Initial Positive Clinical Trial Results for CS-1103: A Novel ... In this investigation, intravenous administration of single doses of CS-1103 was found to be well tolerated with no serious adverse events ...

7. clearsci.com clearsci.com/post/clear-scientific-reports-positive-topline-phase-1-clinical-trial-data-for-cs-1103

Clear Scientific Reports Positive Topline Phase 1 Clinical ... Positive topline data from the First-in-Human Phase 1 clinical trial of its therapeutic CS-1103 that demonstrate a favorable safety and tolerability profile.