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Harmine Hydrochloride Capsules for Diabetes

Phase 1
Waitlist Available
Led By James Murrough, MD, PhD
Research Sponsored by James Murrough
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study, at 18 months
Awards & highlights

Study Summary

This trial is testing how much of the drug harmine healthy volunteers can tolerate. The goal is to find the maximum dose that is safe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study, at 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study, at 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity (DLT)
Secondary outcome measures
Visual Analog Scale (VAS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Harmine DoseExperimental Treatment1 Intervention
There will be a total of seven possible doses that include 100 mg, 200 mg, 300 mg, 500 mg, 700 mg, 900 mg and 1200 mg. Each study subject will receive a single oral dose of harmine in this single ascending dose design.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Harmine Hydrochloride Capsules
2022
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

James MurroughLead Sponsor
8 Previous Clinical Trials
234 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,214 Total Patients Enrolled
107 Trials studying Diabetes
138,663 Patients Enrolled for Diabetes
James Murrough, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
5 Previous Clinical Trials
347 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are being recruited for this clinical trial?

"Affirmative. Clinicaltrials.gov confirms that this research venture, which was initially advertised on September 13th 2022, is in the process of enrolling patients. 40 individuals need to be recruited from 1 medical facility."

Answered by AI

What criteria must be met in order to qualify for this experiment?

"This research is enrolling 40 individuals aged 18-55 with a BMI between 19 and 30 who suffer from diabetes mellitus. As part of the admittance criteria, participants must be able to communicate in English effectively enough to agree to tests or examinations as well as understand the consent process. Additionally, both male and female applicants are encouraged to utilize an accepted contraceptive method throughout this trial while women should not partake if they are breastfeeding."

Answered by AI

Are senior citizens included in the parameters of this investigation?

"This research seeks participants who are between 18 and 55 years of age."

Answered by AI

Is this experiment in need of additional participants at the present time?

"As per the information presented on clinicaltrials.gov, this trial is presently looking for volunteers. The experiment was first announced on September 13th 2022 and its most recent update was issued on October 28th of that same year."

Answered by AI

What risks should be considered prior to taking Harmine Hydrochloride Capsules?

"The safety rating of Harmine Hydrochloride Capsules is 1, as this trial is in the early Phase 1 stage where there has been limited research conducted into its efficacy and security."

Answered by AI

Who else is applying?

What site did they apply to?
Depression and Anxiety Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Study of Harmine in Healthy Subjects
James Murrough 2022. "Study of Harmine in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05526430.
~10 spots leftby Apr 2025
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