Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia

Duke University

Status and phase: Completed; Phase 4

Conditions: Cigarette Smoking; Schizophrenia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02420015

Pro00061683

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

iCOMMIT

Experimental group

Description:

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.

Treatment:

Behavioral: Stay Quit Coach

Behavioral: cognitive-behavioral smoking cessation counseling

Drug: Bupropion

Drug: Nicotine replacement therapy

Behavioral: Mobile Contingency Management

Behavioral: SMS text messaging

Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: cognitive-behavioral smoking cessation counseling

Drug: Bupropion

Drug: Nicotine replacement therapy