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

NCT ID: NCT06721494

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-03

Study Completion Date

2026-09-11

Brief Summary

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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).

Detailed Description

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Conditions

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Methamphetamine Intoxication Methamphetamine Disorders Methamphetamine Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Methamphetamine

Intervention Type DRUG

Methamphetamine HCl for intravenous administration

Sterile Saline

Intervention Type DRUG

Sterile Saline for intravenous administration

Active

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

Group Type ACTIVE_COMPARATOR

Methamphetamine

Intervention Type DRUG

Methamphetamine HCl for intravenous administration

CS-1103

Intervention Type DRUG

CS-1103 for intravenous administration

Interventions

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Methamphetamine

Methamphetamine HCl for intravenous administration

Intervention Type DRUG

Sterile Saline

Sterile Saline for intravenous administration

Intervention Type DRUG

CS-1103

CS-1103 for intravenous administration

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Clear Scientific, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xinhua Li, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Clear Scientific, Inc.

Locations

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California Clinical Trials Medical Group

Glendale, California, United States

Site Status

Countries

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United States

Central Contacts

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Anna Del Rosario, B.S.

Role: CONTACT

Phone: 617-621-8500

Email: [email protected]

Piercen Oliver, Ph.D.

Role: CONTACT

Phone: 617-621-8500

Email: [email protected]

Facility Contacts

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Lev Gertsik, M.D.

Role: primary

Other Identifiers

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5U01DA058548-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CS-1103-02

Identifier Type: -

Identifier Source: org_study_id