← Back to Search

Other

Nicotine patch for Cognitive Impairment

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
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 day 1 or day 8
Awards & highlights

Study Summary

This trial is testing whether people with schizophrenia have a lower response to sound frequencies than healthy controls.

Eligible Conditions
  • Cognitive Impairment

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 or day 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 or day 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean inter-trial coherence (ITC) magnitude of 40 Hz-derived auditory steady-state response (ASSR) in HC and SZ participants
Secondary outcome measures
Duration deviant mismatch negativity (DD-MMN) in HC and SZ participants
Effect of nicotine on mean ITC magnitude of 40 Hz-derived ASSR in HC and SZ participants
Plasma nicotine level during event related potential (ERP) recording

Side effects data

From 2020 Phase 4 trial • 1251 Patients • NCT03176784
30%
Nausea
30%
Insomnia
17%
Skin Rash
16%
Changes in Mood
13%
Itching/Hives
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Varenicline + Patch Standard Duration
Varenicline + Patch Extended Duration
Varenicline Only Standard Duration
Varenicline Only Extended Duration

Trial Design

2Treatment groups
Experimental Treatment
Group I: Panel B: Participants with Mild-to-Moderate SZExperimental Treatment4 Interventions
In Part 1, participants with mild-to-moderate SZ receive nicotine patch + capsule placebo, and patch placebo + capsule placebo, under a cross-over design in Periods 1 and 2. In Part 2 (Period 3), SZ participants are randomly assigned to receive either MK-4334 250 mg capsule + patch placebo or capsule placebo + patch placebo.
Group II: Panel A: Healthy Control ParticipantsExperimental Treatment4 Interventions
In Part 1, HC participants receive nicotine patch + capsule placebo, and patch placebo + capsule placebo, under a cross-over design in Periods 1 and 2. In Part 2 (Period 3), HC participants are randomly assigned to receive either MK-4334 250 mg capsule + patch placebo or capsule placebo + patch placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine patch
2015
Completed Phase 4
~7450
MK-4334
2022
Completed Phase 1
~40
Placebo patch
2014
Completed Phase 4
~4910
Placebo capsule
2015
Completed Phase 4
~5270

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,784 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,533 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,442 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)
2022. "Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05136690.
~13 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top