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Study of Antibody for Methamphetamine Outpatient Therapy

NCT03336866 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2022-03-10

Study results available
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Summary

This study evaluates the ability of IXT-m200 to change methamphetamine concentrations in blood and alter the way methamphetamine feels. Participants will receive either placebo, a low or high dose of IXT-m200, in addition to methamphetamine challenge doses.

Conditions

  • Methamphetamine-dependence
  • Methamphetamine Abuse

Interventions

DRUG

Placebo

Normal saline

DRUG

IXT-m200

IXT-m200 is an anti-methamphetamine monoclonal antibody

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • InterveXion Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Lynn Webster, MD · PRA Health Sciences

  • Peter Winkle, MD · Anaheim Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-03
Primary Completion
2020-11-23
Completion
2021-03-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03336866 on ClinicalTrials.gov