Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia, Smoking Cessation |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/6/2019 |
| Start Date: | March 27, 2017 |
| End Date: | January 24, 2019 |
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.
at helping smokers with schizophrenia stop smoking. iCOMMIT is a smoking cessation treatment
that combines mobile technology with behavioral strategies, counseling, and medications.
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.
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.
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
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Jean C Beckham, Ph.D.
Phone: 919-684-1079
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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