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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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.

How does the drug CS-1103 differ from other treatments for methamphetamine abuse?

The research does not provide specific information about CS-1103, but it highlights that many existing treatments for methamphetamine abuse, such as dopamine partial agonists and GABAergic agents, have not been effective. This suggests that CS-1103 may offer a novel approach, potentially targeting different mechanisms or using a unique formulation. ^{1 2 3 4 5}

Research Team

Xinhua Li, Ph.D.

Principal Investigator

Clear Scientific, Inc.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

An open-label pilot study of risperidone in the treatment of methamphetamine dependence. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Implications of chronic methamphetamine use: a literature review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Public health consequences among first responders to emergency events associated with illicit methamphetamine laboratories--selected states, 1996-1999. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Pharmacological approaches to methamphetamine dependence: a focused review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical features of sensitization to methamphetamine observed in patients with methamphetamine dependence and psychosis. [2013]