Clinical trial NCT02420015: Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia
Official title: Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Cigarette Smoking
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Self-report Prolonged Abstinence
timeFrame: 6 month follow-up
measure: Number of Participants Whose Prolonged Abstinence is Bio-verified
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Number of Participants Who Report 7 Day Point Prevalence Abstinence
timeFrame: 3 months post-quit attempt (Session 5)
measure: Number of Participants Who Report 30 Day Point Prevalence Abstinence
timeFrame: 3 months post-quit attempt (Session 5)
measure: Number of Participants Who Report 7 Day Point Prevalence Abstinence
timeFrame: 6 months post-quit attempt (Session 6)
measure: Number of Participants Who Report 30 Day Point Prevalence Abstinence
timeFrame: 6 months post-quit attempt (Session 6)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jean C Beckham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: