Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia

Phase 4

Completed

Conditions: Schizophrenia
Cigarette Smoking

Interventions: Drug: Nicotine replacement therapy
Drug: Bupropion
Behavioral: cognitive-behavioral smoking cessation counseling
Behavioral: Mobile Contingency Management
Behavioral: Stay Quit Coach
Behavioral: SMS text messaging

Registration Number: NCT02420015

Lead Sponsor: Duke University

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Bupropion	The components of the intervention include 1) pharmacotherapy for smoking cessation \[including nicotine replacement therapy (NRT) and bupropion\]; and 2) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation.
Control Group	cognitive-behavioral smoking cessation counseling	The components of the intervention include 1) pharmacotherapy for smoking cessation \[including nicotine replacement therapy (NRT) and bupropion\]; and 2) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation.
iCOMMIT	cognitive-behavioral smoking cessation counseling	The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation \[including nicotine replacement therapy (NRT) and bupropion\]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence.
iCOMMIT	Mobile Contingency Management	The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation \[including nicotine replacement therapy (NRT) and bupropion\]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence.
iCOMMIT	Stay Quit Coach	The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation \[including nicotine replacement therapy (NRT) and bupropion\]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence.
iCOMMIT	SMS text messaging	The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation \[including nicotine replacement therapy (NRT) and bupropion\]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence.
iCOMMIT	Nicotine replacement therapy	The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation \[including nicotine replacement therapy (NRT) and bupropion\]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence.
Control Group	Nicotine replacement therapy	The components of the intervention include 1) pharmacotherapy for smoking cessation \[including nicotine replacement therapy (NRT) and bupropion\]; and 2) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation.
iCOMMIT	Bupropion	The components of the intervention include 1) behavioral therapy in the form of mobile contingency management (mCM) designed to increase early abstinent rates; 2) pharmacotherapy for smoking cessation \[including nicotine replacement therapy (NRT) and bupropion\]; 3) four sessions of guideline based cognitive-behavioral smoking cessation counseling designed to increased coping skills specific to smoking cessation; 4) a smart-phone based relapse prevention application (the Stay Quit Coach) that is populated during the counseling sessions; and 5) SMS text messaging reminders to increase medication adherence.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Self-report Prolonged Abstinence	6 month follow-up	Prolonged abstinence will exclude tobacco use in the first two weeks following the quit date, as is consistent with other smoking cessation trials.
Number of Participants Whose Prolonged Abstinence is Bio-verified	6 month follow-up	Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence at each follow-up.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Report 30 Day Point Prevalence Abstinence	6 months post-quit attempt (Session 6)	Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days.
Number of Participants Who Report 7 Day Point Prevalence Abstinence	6 months post-quit attempt (Session 6)	Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days.