Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia

NCT02420015 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00061683
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Cigarette Smoking

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Self-report Prolonged Abstinence

  Prolonged abstinence will exclude tobacco use in the first two weeks following the quit date, as is consistent with other smoking cessation trials.

  6 month follow-up

• Number of Participants Whose Prolonged Abstinence is Bio-verified

  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.

  6 month follow-up

Secondary Outcomes (4)

• Number of Participants Who Report 7 Day Point Prevalence Abstinence

  3 months post-quit attempt (Session 5)

• Number of Participants Who Report 30 Day Point Prevalence Abstinence

  3 months post-quit attempt (Session 5)

• Number of Participants Who Report 7 Day Point Prevalence Abstinence

  6 months post-quit attempt (Session 6)

• Number of Participants Who Report 30 Day Point Prevalence Abstinence

  6 months post-quit attempt (Session 6)

Study Arms (2)

iCOMMIT

EXPERIMENTAL

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.

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

Control Group

ACTIVE COMPARATOR

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.

Drug: Nicotine replacement therapy; Drug: Bupropion; Behavioral: cognitive-behavioral smoking cessation counseling

Interventions

Nicotine replacement therapy DRUG

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

Also known as: nicotine gum, patch, inhaler, and/or lozenge

Control Group; iCOMMIT

Bupropion DRUG

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

Also known as: Zyban

Control Group; iCOMMIT

cognitive-behavioral smoking cessation counseling BEHAVIORAL

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.

Control Group; iCOMMIT

Mobile Contingency Management BEHAVIORAL

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.

Also known as: mCM

iCOMMIT

Stay Quit Coach BEHAVIORAL

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.

iCOMMIT

SMS text messaging BEHAVIORAL

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.

Also known as: texting

iCOMMIT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27706, United States

Location

MeSH Terms

Conditions

Schizophrenia; Cigarette Smoking

Interventions

Nicotine Replacement Therapy; Nicotine Chewing Gum; Transdermal Patch; Nebulizers and Vaporizers; Bupropion

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Equipment and Supplies; Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Angela Kirby
• Organization: Duke University School of Medicine

angela.kirby@duke.edu

919-286-0411

Study Officials

• Jean C Beckham, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 17, 2015
• Study Start: March 27, 2017
• Primary Completion: January 24, 2019
• Study Completion: January 24, 2019
• Last Updated: July 10, 2019
• Results First Posted: July 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)