CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Active JNJ Drug +1 moredrug
Likely dose
Active JNJ Drug 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02230384
NCT02230384Phase 2Completed

The Development of of A Novel Therapeutic to Aid Tobacco Smoking Cessation in Persons With Schizophrenia or Schizoaffective Disorder

K.N. Roy Chengappa·interventional·Posted Sep 3, 2014·Updated Apr 2, 2019

In Brief

A Phase 2 clinical trial evaluating Active JNJ Drug and Placebo Pill for Smoking Cessation. Completed, enrolled 62 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 3, 2014
Enrollment StartSep 1, 2014
Primary CompletionDec 16, 2016
Study CompletionMar 9, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.8 years ago

Interventions

Active JNJ Drugdrug

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

Placebo Pilldrug

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