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SchizophreniaPhase 4NCT02420015

Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia

A Phase 4 study testing Nicotine replacement therapy, Bupropion and cognitive-behavioral smoking cessation counseling in people with Schizophrenia and Cigarette Smoking, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Schizophrenia, Cigarette Smoking
What is being tested?
Nicotine replacement therapy, Bupropion and cognitive-behavioral smoking cessation counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
27 Mar 2017to 24 Jan 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27706

Other trials in United States

About this study

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.

Read the 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.

Being tested
Nicotine replacement therapy, Bupropion, cognitive-behavioral smoking cessation counseling, Mobile Contingency Management, Stay Quit Coach
Medical subject headings
Schizophrenia, Cigarette Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nicotine replacement therapyDrug

    Also called nicotine gum, patch, inhaler, and/or lozenge

    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

  • BupropionDrug

    Also called Zyban

    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 counselingBehavioural

    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 ManagementBehavioural

    Also called mCM

    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 CoachBehavioural

    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 messagingBehavioural

    Also called texting

    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.

Study groups in NCT02420015
Study groupRoleWhat they receive
iCOMMITExperimentalThe 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.
Receives: 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 GroupActive comparatorThe 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.
Receives: Drug: Nicotine replacement therapy; Drug: Bupropion; Behavioral: cognitive-behavioral smoking cessation counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 month follow-up

  2. 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.

    Measured: 6 month follow-up

Secondary outcomes (4)

  1. Number of Participants Who Report 7 Day Point Prevalence Abstinence

    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.

    Measured: 3 months post-quit attempt (Session 5)

  2. Number of Participants Who Report 30 Day Point Prevalence Abstinence

    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.

    Measured: 3 months post-quit attempt (Session 5)

  3. Number of Participants Who Report 7 Day Point Prevalence Abstinence

    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.

    Measured: 6 months post-quit attempt (Session 6)

  4. Number of Participants Who Report 30 Day Point Prevalence Abstinence

    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.

    Measured: 6 months post-quit attempt (Session 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2015 (estimated)
  2. Study start27 Mar 2017
  3. Primary completion24 Jan 2019
  4. Study completion24 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02420015
Sponsor's protocol ID
Pro00061683
Status last verified
Jun 2019
First submitted
14 Apr 2015
Last updated
10 Jul 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nicotine replacement therapy, Bupropion and cognitive-behavioral smoking cessation counseling in people with Schizophrenia and Cigarette Smoking, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Self-report Prolonged Abstinence (time frame: 6 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02420015.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.

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