NIDA Launches First Phase 1 Human Trial of Purified Mitragynine for Opioid Use Disorder

Why it matters

The National Institute on Drug Abuse is conducting the first Phase 1 safety and tolerability trial of MG001, a purified mitragynine formulation, in healthy human volunteers. This represents the first government-sponsored human study of mitragynine as a potential treatment for opioid withdrawal symptoms.

The big picture

NCT07204171 is a randomized, double-blind, placebo-controlled single ascending dose study enrolling 32 healthy adults with recent oral opioid use history. Participants will receive escalating doses (25mg, 50mg, 75mg, 100mg) or placebo under fasting conditions. NIDA's involvement signals growing scientific interest in exploring mitragynine's therapeutic potential for opioid use disorder, where patients report using kratom to manage withdrawal symptoms.

Key findings

• Study design: Phase 1, first-in-human randomized, double-blind, placebo-controlled trial
• Enrollment: ~32 healthy volunteers aged 18-65 with recent opioid use history
• Dose escalation: 4 ascending dose levels (25-100mg mitragynine) versus placebo
• Study period: 3 nights inpatient observation on dosing day, plus Day 7 follow-up
• Estimated timeline: February 2026 to August 2026
• Primary outcomes: Safety, tolerability, and pharmacokinetics

What they say

Study Brief Summary: 'This research study is the first time the new medication MG001 is being tested in people. MG001 is a formulation of mitragynine, a compound that comes from a plant called Mitragyna speciosa (sometimes known as kratom), which some people use on their own to help manage symptoms of opioid withdrawal.'

Bottom line

NIDA's first human trial of purified mitragynine reflects emerging scientific focus on kratom's potential as an opioid use disorder treatment, distinct from recreational or whole-plant products.