MG001 for Opiate Dependence

Overseen By Sage Hannan, BA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute on Drug Abuse (NIDA)

Must not be taking: Kratom, Investigational drugs, Opioids

Disqualifiers: Cardiac, Hepatic, Renal, Psychiatric, others

Compensation: Varies

Number of Visits: 36

Duration: 4 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication called MG001, derived from a plant compound known as kratom, to assess its safety and how the body processes it. MG001 may help manage opioid withdrawal symptoms, but this marks its first test in humans. Participants will receive either MG001 at various doses or a placebo (a harmless pill with no active drug) and will be monitored closely for any side effects. The trial seeks healthy adults who have recently used oral opioids but not regularly and who can adhere to study guidelines. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any medications, including prescription, over-the-counter, dietary supplements, herbal products, vitamins, or those interacting with certain enzymes, at least 14 days before the study and throughout the trial.

Is there any evidence suggesting that MG001 is likely to be safe for humans?

Research shows that MG001, a new treatment for opioid dependence, is undergoing its first human trials. As this is an early study, information about its safety in people remains limited. MG001 contains mitragynine, a compound from the Mitragyna speciosa plant, commonly known as kratom. Some individuals use kratom independently to alleviate opioid withdrawal symptoms, though the safety of this practice varies.

Since MG001 is being tested in humans for the first time, its safety is not yet known. Study participants will be closely monitored to assess their response to different doses. Researchers will observe any side effects and how the body processes the drug. This early-phase study aims to gather initial safety information to ensure the treatment is not harmful before advancing to later studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MG001 for opiate dependence because it offers a potentially groundbreaking approach to treatment. Unlike traditional options like methadone or buprenorphine, which work by substituting the opiate with a less harmful substance, MG001 might work through a novel mechanism that directly targets certain brain pathways involved in addiction. Additionally, MG001 is administered orally, which can be more convenient and less invasive than treatments requiring injections or implants. This new treatment could provide a more effective and patient-friendly alternative for individuals struggling with opiate addiction.

What evidence suggests that MG001 might be an effective treatment for opiate dependence?

Research suggests that mitragynine, a substance in the plant Mitragyna speciosa (kratom), might help with opioid withdrawal symptoms. Some people use kratom independently to ease these symptoms and reduce illegal opioid use. Such medications are believed to help manage withdrawal and lower opioid use. Although direct clinical trial data on MG001 remains limited, its mechanism shows promise. Mitragynine interacts with opioid receptors, potentially relieving withdrawal symptoms. However, these findings are preliminary, and further research is necessary. ^{1 6 7 8 9}

Who Is on the Research Team?

Julia Solarczyk Donnelly, MS, RAC

Principal Investigator

National Institute on Drug Abuse, NIH

Are You a Good Fit for This Trial?

This trial is for healthy adults who can pass screening tests to ensure they're eligible. It's the first test of MG001, a new medication derived from Mitragyna speciosa (kratom), aimed at managing opioid withdrawal symptoms.

Inclusion Criteria

Ability to speak English sufficiently to understand study procedures and provide written informed consent

Ability and willingness to comply with protocol requirements and complete all study treatments

I am between 18 and 65 years old and healthy.

Exclusion Criteria

Clinically significant findings within one year of screening that contraindicate study participation

History of suicide attempts or evidence of suicidal ideation

Evidence of specific cardiac abnormalities or other findings on screening ECG

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Outpatient visits between Day -28 and Day -2, inpatient visit on Day -1

Treatment

Participants receive a single dose of MG001 or placebo after fasting for at least 10 hours, followed by safety and PK assessments

4 days

Inpatient stay from Day 1 to Day 4

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a final PK sample collected

3 days

Follow-up visit on Day 7

What Are the Treatments Tested in This Trial?

Interventions

• MG001

Trial Overview MG001, an oral formulation of mitragynine, is being tested against a placebo for safety and how the body processes it. Participants will be randomly assigned to receive either MG001 or a placebo in a controlled clinic environment.

How Is the Trial Designed?

Group I: 75 mg dose Experimental Treatment 1 Intervention

oral administration in fasted state

Group II: 50 mg dose Experimental Treatment 1 Intervention

oral administration in fasted state

Group III: 25 mg dose Experimental Treatment 1 Intervention

oral administration in fasted state

Group IV: 100 mg dose Experimental Treatment 1 Intervention

oral administration in fasted state

Group V: Placebo Placebo Group 1 Intervention

oral administration in fasted state

Who Is Running the Clinical Trial?

National Institute on Drug Abuse (NIDA)

Lead Sponsor

Trials

2,658

Recruited

3,409,000+

Technical Resources International, Inc. (TRI)

Collaborator

Trials

3

Recruited

2,300+

Altasciences Clinical Kansas, Inc.

Collaborator

Trials

1

Recruited

30+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK553166/

Opioid Use Disorder: Evaluation and Management - NCBI - NIH Opioid use disorder (OUD) is defined as the chronic use of opioids that causes clinically significant distress or impairment.

2. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates In 2022, 3.7% of US adults aged ≥18 years needed OUD treatment. Among these, only 25.1% received medications for OUD.

3. fda.gov fda.gov/media/114948/download

Opioid Use Disorder: Endpoints for Demonstrating ... In general, clinical trials evaluating effectiveness of drugs for treating OUD have used reduction in drug-taking behavior (drug use patterns) as an endpoint.

4. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2021.721357/full

Opioids and Chronic Pain: An Analytic Review of the ... The estimated risk of death from opioid treatment involving doses above 100 MMED is ~0.25%/year. Multiple large studies refute the concept that short-term use ...

5. pew.org pew.org/en/research-and-analysis/fact-sheets/2020/12/medications-for-opioid-use-disorder-improve-patient-outcomes

Medications for Opioid Use Disorder Improve Patient ... Evidence of effectiveness. Using medications to treat opioid use disorder helps people manage withdrawal symptoms, reduce illicit opioid use, ...

6. fda.gov fda.gov/drugs/information-drug-class/information-about-medications-opioid-use-disorder-moud

Information about Medications for Opioid Use Disorder ... All three of these treatments have been demonstrated to be safe and effective. FDA is working to identify treatment needs, expand access to ...

7. cdc.gov cdc.gov/overdose-prevention/prevention/preventing-opioid-use-disorder.html

Preventing Opioid Use Disorder | Overdose Prevention Never take prescription opioids in greater amounts or more often than prescribed. Avoid taking opioids with alcohol and other substances or ...

8. hopkinsmedicine.org hopkinsmedicine.org/health/conditions-and-diseases/opioid-use-disorder

Opioid Use Disorder Opioid use disorder (OUD) is a complex illness characterized by compulsive use of opioid drugs even when the person wants to stop.

9. medlineplus.gov medlineplus.gov/opioidsandopioidusedisorderoud.html

Opioids and Opioid Use Disorder (OUD) Opioids can cause side effects such as drowsiness, mental fog, nausea, and constipation. They may also cause slowed breathing, which can lead to ...