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

Clear Scientific

Status and phase: Enrolling; Phase 2

Conditions: Methamphetamine Intoxication; Methamphetamine Disorders; Methamphetamine Abuse

Treatments: Drug: Sterile Saline; Drug: Methamphetamine; Drug: CS-1103

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT06721494

5U01DA058548-02 (U.S. NIH Grant/Contract)

CS-1103-02

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Methamphetamine

Drug: Sterile Saline

Active

Active Comparator group

Description:

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

Treatment:

Drug: CS-1103

Drug: Methamphetamine