Effects of Transdermal Nicotine on Response Inhibition to Emotional Cues in Schizophrenia

NCT03838484 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-04-29

Study results available
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Summary

The purpose of this study is to test whether nicotine, a drug that activates receptors called nicotinic acetylcholine receptors in the brain, improves the ability to make or withhold responses to faces that are either emotionally neutral or emotionally negative. This study will also test whether the drug affects brain activity while making or withholding responses using electroencephalography. Previous studies in people with schizophrenia have shown that more errors in response to negative emotional cues are related to greater likelihood of impulsive aggressive behavior. Therefore, the aim of this study is to determine whether nicotine might be a new strategy to reduce aggressive behavior. The investigators' goal is 25 individuals with schizophrenia and 25 healthy controls to complete the study at Vanderbilt.

Conditions

Interventions

DRUG

Nicotine Patch, 7 Mg/24 Hr

Nicotine patch, 7 mg/24 hour will be applied to the skin.

DRUG

Placebo patch

Placebo skin patch will be applied to the skin.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • University of Florida

    collaborator OTHER
  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Alan S Lewis, MD, PhD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-10
Primary Completion
2020-02-24
Completion
2020-02-24

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03838484 on ClinicalTrials.gov