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NCT06721494 | NOT YET RECRUITING | Methamphetamine Intoxication

A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
Sponsor:

Clear Scientific, Inc.

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).

Condition or disease

Methamphetamine Intoxication

Methamphetamine Disorders

Methamphetamine Abuse

Intervention/treatment

Methamphetamine

Sterile Saline

CS-1103

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-06-02
Estimated Primary Completion Date : 2026-01-06
Estimated Study Completion Date : 2026-02-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 50 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.
A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine

Location Details

NCT06721494

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How to Participate

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Locations

Not yet recruiting

United States, California

California Clinical Trials Medical Group

Glendale, California, United States, 91206