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Scopolamine for Muscarinic Receptor Engagement (emo_to2 Trial)

Phase 1

Waitlist Available

Led By David Matuskey, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and up to 48 hours post scopolamine infusion

Awards & highlights

emo_to2 Trial Summary

This trial tests how much of a scopolamine drug reaches the brain after a single dose, in healthy people, to assess its effects.

Who is the study for?

Healthy adults aged 18-60 who can consent, read, write, and follow study directions. They must be in good health based on medical history, exams, and tests. Excluded are those with hepatitis B/C or HIV; IV drug use history; abnormal lab results or ECG; pregnant/lactating women; recent prescription meds users (with exceptions); scopolamine patch users within 14 days; participants in other trials recently involving drugs or radiotracers; current smokers/nicotine users; substance abuse history within 2 years; positive drug screening.Check my eligibility

What is being tested?

The trial is testing how the body's M1 Muscarinic Receptors in the brain respond to different doses of scopolamine given intravenously. It uses a special imaging tracer called [11C]EMO ([11C]LSN3172176) during PET and MRI scans to measure this response in healthy volunteers.See study design

What are the potential side effects?

Potential side effects from scopolamine may include dry mouth, blurred vision, dizziness, confusion, difficulty urinating. The radiotracer used for imaging might cause temporary discomfort at the injection site.

emo_to2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and up to 48 hours post scopolamine infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and up to 48 hours post scopolamine infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to 48 hours post scopolamine infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in brain muscarinic receptor occupancy with [11C]LSN3172176 PET

emo_to2 Trial Design

2Treatment groups

Experimental Treatment

Group I: Scopolamine low doseExperimental Treatment2 Interventions

The target occupancy (TO) of scopolamine at M1 will be evaluated using the radiotracer [11C]EMO and positron emission tomography (PET). TO will be measured following a 15-minute IV infusion of 2.0 μg/kg scopolamine in 0-2 anticipated participants.

Group II: Scopolamine high doseExperimental Treatment2 Interventions

The target occupancy (TO) of scopolamine at M1 will be evaluated using the radiotracer [11C]EMO and positron emission tomography (PET). TO will be measured following a 15-minute IV infusion of 4.0 μg/kg scopolamine in 4-6 anticipated participants.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Scopolamine

2011

Completed Phase 4

~27650

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Janssen Scientific Affairs, LLCIndustry Sponsor

159 Previous Clinical Trials

580,512 Total Patients Enrolled

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,736,522 Total Patients Enrolled

David Matuskey, MDPrincipal InvestigatorYale University

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

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

Are there any adverse effects associated with administering high doses of Scopolamine?

"Scopolamine high dose has only been evaluated in a limited capacity, so its safety rating is relatively low at 1. This implies that the efficacy of this treatment has not yet been established."

Answered by AI

Are there any openings left for volunteers in this clinical trial?

"According to data hosted on clinicaltrials.gov, recruitment for this trial has been suspended since August 31st 2023. The initial posting of the study was October 1st 2023. Despite its current inactivity, there are still other medical trials that are actively searching for volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PET and MRI Imaging With Scopolamine at the Muscarinic M1 Receptor

David Matuskey 2024. "PET and MRI Imaging With Scopolamine at the Muscarinic M1 Receptor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06014385.

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