Recruiting
Phase 2

CS-1103

Sponsor:

Clear Scientific, Inc.

Code:

NCT06721494

Conditions

Methamphetamine Intoxication

Methamphetamine Disorders

Methamphetamine Abuse

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Methamphetamine

Sterile Saline

CS-1103

Study Details

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).

Conditions

Methamphetamine Intoxication

Methamphetamine Disorders

Methamphetamine Abuse

Study ID

NCT06721494

Start date

Feb 5, 2026

Status verified date

Jul, 2026

Completion date

Sep 11, 2026

Anticipated

Primary completion date

Sep 4, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

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

active comparator: Active

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

Interventions

Methamphetamine

Methamphetamine HCl for intravenous administration

Sterile Saline

Sterile Saline for intravenous administration

CS-1103

CS-1103 for intravenous administration

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 ]
  • Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs) [ Time Frame: 3 days plus follow-up on Day 10 ]
  • Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs [ Time Frame: 3 days plus follow-up on Day 10 ]
  • Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters [ Time Frame: 3 days plus follow-up on Day 10 ]
  • Time course and magnitude of urine excretion of methamphetamine [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

Locations

California Clinical Trials Medical Group

Recruiting

Glendale, California, United States, 91206

Contacts

More Information

Sponsor

Clear Scientific, Inc.

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Clear Scientific, Inc. on 2026-07-07.