Durham, North Carolina 27706


Purpose:

This study is designed to evaluate if a treatment the investigators call iCOMMIT is effective at helping smokers with schizophrenia stop smoking. iCOMMIT is a smoking cessation treatment that combines mobile technology with behavioral strategies, counseling, and medications.


Study summary:

The purpose of this 2-arm randomized controlled trial (RCT) is to evaluate the efficacy of Multi-Component Mobile-enhanced Treatment for Smoking Cessation (iCOMMIT) in helping individuals with schizophrenia or other psychotic disorders stop smoking. Eligible participants will be randomized to receive iCOMMIT, which includes smoking cessation counseling, pharmacotherapy, and mobile technology components, or a control intervention that includes smoking cessation counseling and pharmacotherapy, but no mobile technology components. The control condition represents an intensive standard of care and helps control for monitoring, counselor, time, and attention effects. The primary outcome for the study will be self-reported and bio-verified prolonged smoking abstinence at the 6-month follow-up. Self-reported prolonged abstinence will be verified by saliva cotinine assay. Secondary outcomes will include 7- and 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 or 30 days.


Criteria:

Inclusion Criteria: - Currently smoke at least ten cigarettes a day - Have been smoking for at least one year - Meet criteria for schizophrenia, schizoaffective disorder, or another psychotic disorder based on structured clinical interview - Can speak and write fluent conversational English - Are between 18 and 70 years of age - Are willing to make a smoking cessation attempt - Score 26 or higher on the Montreal Cognitive Assessment Exclusion Criteria: - Have a history of myocardial infarction in the past 6 months - Have a contraindication to NRT with no medical clearance from the primary care provider or study physician - Use and unwillingness to stop use of other forms of nicotine such as cigars, pipes, or chewing tobacco - Are pregnant - Meet criteria for a current manic episode based on structured clinical interview - Are currently enrolled in another smoking cessation trial - Are currently imprisoned or in psychiatric hospitalization


NCT ID:

NCT02420015


Primary Contact:

Principal Investigator
Jean C Beckham, Ph.D.
Duke University

Angela C Kirby, MS
Phone: 919-684-1079
Email: angela.kirby@duke.edu


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27706
United States

Alex Thompson
Phone: 919-684-1079
Email: alex.thompson@duke.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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