Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia
NCT ID: NCT02420015
Last Updated: 2019-07-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
35 participants
INTERVENTIONAL
2017-03-27
2019-01-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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iCOMMIT
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.
Nicotine replacement therapy
Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum, nicotine inhaler, or nicotine nasal spray, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion
All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 3-month follow-up
cognitive-behavioral smoking cessation counseling
Participants will receive four 20-minute smoking cessation counseling sessions and a participant manual. The four sessions are based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation.
Mobile Contingency Management
Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence.
Stay Quit Coach
Stay Quit Coach is a smart phone application that serves as a source of readily available support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. The app guides user in creating tailored plans that include their personal reasons for quitting, interactive tools to help users cope with urges to smoke, motivational messages, support contacts to help users stay smoke free and how to address lapses. Participants assigned to this condition will be asked to use Stay Quit Coach from Session 2 through the 6-month follow-up.
SMS text messaging
Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt, including messages reminding participants to take their smoking cessation medication.
Control Group
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.
Nicotine replacement therapy
Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum, nicotine inhaler, or nicotine nasal spray, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion
All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 3-month follow-up
cognitive-behavioral smoking cessation counseling
Participants will receive four 20-minute smoking cessation counseling sessions and a participant manual. The four sessions are based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation.
Interventions
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Nicotine replacement therapy
Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum, nicotine inhaler, or nicotine nasal spray, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion
All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 3-month follow-up
cognitive-behavioral smoking cessation counseling
Participants will receive four 20-minute smoking cessation counseling sessions and a participant manual. The four sessions are based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation.
Mobile Contingency Management
Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence.
Stay Quit Coach
Stay Quit Coach is a smart phone application that serves as a source of readily available support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. The app guides user in creating tailored plans that include their personal reasons for quitting, interactive tools to help users cope with urges to smoke, motivational messages, support contacts to help users stay smoke free and how to address lapses. Participants assigned to this condition will be asked to use Stay Quit Coach from Session 2 through the 6-month follow-up.
SMS text messaging
Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt, including messages reminding participants to take their smoking cessation medication.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Jean C Beckham, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro00061683
Identifier Type: -
Identifier Source: org_study_id
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