NCT03106571

Study of Pomaglumetad and Methamphetamine

Phase 1 Safety-interaction Study of Pomaglumetad Methionil for Methamphetamine Use Disorder

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is the first study of pomaglumetad in humans using methamphetamine. The goal of the study is to determine if pomaglumetad is safe when administered with methamphetamine. If shown to be safe with methamphetamine in the current study, a phase 2 clinical trial of pomaglumetad would be done to begin to find out if pomaglumetad is effective in treating methamphetamine use disorder.

Detailed description

The study design is a randomized, double-blind, placebo-controlled multiple ascending-dose study of pomaglumetad in 24 non-treatment seeking participants with methamphetamine use disorder. Three cohorts of 8 participants each (total N = 24) will be enrolled and within each cohort participants will be randomly assigned in a 6:2 ratio to undergo methamphetamine infusions and assessments during treatment with pomaglumetad (N = 6 per cohort) or placebo (N = 2 per cohort). Participants in cohort 1 will receive pomaglumetad 40 mg orally twice daily (BID) or placebo, cohort 2 will receive pomaglumetad 80 mg BID or placebo, and cohort 3 will receive pomaglumetad 160 mg BID or placebo. After completing outpatient baseline and screening/eligibility assessments, eligible participants will be admitted to the UCLA Hospital and will remain hospitalized during all experimental procedures (approximately 11 days and 10 nights). A urine drug toxicology screen free of illicit substances (with the exception of THC) is required for admission. Upon admission, participants will receive a sample/test infusion of MA 30 mg IV. Participants tolerating the test infusion (no serious adverse advents and not exceeding stopping criteria below) will be randomized to receive POMA (40 mg BID in cohort 1, 80 mg BID in cohort 2, and 160 mg BID in cohort 3) or placebo. Following three days of MA abstinence and POMA/placebo dosing to achieve study medication steady-state, participants will complete a MA self-administration session. After two days for MA washout, participants will then have serial plasma samples collected over 12 hours to assess PK for POMA. The next day, participants will receive a 30 mg MA infusion followed by serial plasma sample collection over the following 48 hours for MA PK analysis. Measures of cardiovascular response, subjective effects, and adverse events will be assessed following all MA infusions during self-administration and PK sessions. Upon completion of the PK sample collection, participants will be discharged and a 14-day post-discharge (± 7 days) follow-up outpatient visit will be completed for safety purposes.

Conditions

• Methamphetamine Use Disorder

Interventions

Type	Name	Description
DRUG	Pomaglumetad methionil	Tablets twice daily
DRUG	Placebo	1-4 tablets twice daily
DRUG	Methamphetamine	intravenous methamphetamine

Timeline

• Start date: 2017-08-01
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2017-04-10
• Last updated: 2020-09-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study