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Novel Smoking Cessation Drug for Schizophrenia

NCT02230384 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2019-04-02

Study results available
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Summary

The investigators will evaluate effects of a novel drug that improves nicotinergic receptor function vs. placebo on short-term smoking abstinence in smokers with schizophrenia who have a high interest in quitting. The investigators predict that the novel drug will increase days of abstinence, compared with placebo, identifying potential evidence of efficacy for smoking cessation in smokers with schizophrenia.

The investigators will also assess if this new drug decreases nicotine withdrawal, craving, and cognitive impairment during early abstinence, as well as evaluate adverse effects.

Conditions

  • Smoking Cessation

Interventions

DRUG

Active JNJ Drug

200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week

DRUG

Placebo Pill

Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Virginia Commonwealth University

    collaborator OTHER

  • K.N. Roy Chengappa

    lead OTHER

Principal Investigators

  • K.N. Roy Chengappa, MD · Western Psychiatric Institute and Clinic - UPMC

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-12-16
Completion
2017-03-09

Countries

  • United States

Study Locations

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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 NCT02230384 on ClinicalTrials.gov