Schizophrenia, Cigarette Smoking
Conditions
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.
Interventions
DRUGNicotine 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
DRUGBupropion
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
BEHAVIORALcognitive-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.
BEHAVIORALMobile 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.
BEHAVIORALStay 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.
BEHAVIORALSMS 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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Self-report Prolonged Abstinence | 6 month follow-up | Prolonged abstinence will exclude tobacco use in the first two weeks following the quit date, as is consistent with other smoking cessation trials. |
| Number of Participants Whose Prolonged Abstinence is Bio-verified | 6 month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Report 7 Day Point Prevalence Abstinence | 3 months post-quit attempt (Session 5) | 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. |
| Number of Participants Who Report 30 Day Point Prevalence Abstinence | 3 months post-quit attempt (Session 5) | 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. |
Countries
United States
Participant flow
Pre-assignment details
One participant was deemed ineligible to participate in the study prior to randomization because that participant couldn't read or write English.
Participants by arm
| Arm | Count |
|---|---|
| iCOMMIT Components include:
1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.
2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
3. 4 sessions cognitive-behavioral smoking cessation counseling;
4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.
5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt. | 21 |
| Control Group Components include:
1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
2. 4 sessions cognitive-behavioral smoking cessation counseling; | 13 |
| Total | 34 |
Baseline characteristics
| Characteristic | iCOMMIT | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 49.24 years STANDARD_DEVIATION 10.3 | 48.39 years STANDARD_DEVIATION 10.2 | 46.92 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 33 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 19 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 1 Participants |
| Region of Enrollment United States | 21 participants | 34 participants | 13 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 3 Participants |
| Sex: Female, Male Male | 14 Participants | 24 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 13 |
| other Total, other adverse events | 13 / 21 | 12 / 13 |
| serious Total, serious adverse events | 2 / 21 | 3 / 13 |
Outcome results
Primary
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.
Time frame: 6 month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCOMMIT | Number of Participants Who Self-report Prolonged Abstinence | 6 Participants |
| Control Group | Number of Participants Who Self-report Prolonged Abstinence | 3 Participants |
Primary
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.
Time frame: 6 month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCOMMIT | Number of Participants Whose Prolonged Abstinence is Bio-verified | 3 Participants |
| Control Group | Number of Participants Whose Prolonged Abstinence is Bio-verified | 2 Participants |
Secondary
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.
Time frame: 3 months post-quit attempt (Session 5)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCOMMIT | Number of Participants Who Report 30 Day Point Prevalence Abstinence | 2 Participants |
| Control Group | Number of Participants Who Report 30 Day Point Prevalence Abstinence | 1 Participants |
Secondary
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.
Time frame: 6 months post-quit attempt (Session 6)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCOMMIT | Number of Participants Who Report 30 Day Point Prevalence Abstinence | 1 Participants |
| Control Group | Number of Participants Who Report 30 Day Point Prevalence Abstinence | 2 Participants |
Secondary
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.
Time frame: 6 months post-quit attempt (Session 6)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCOMMIT | Number of Participants Who Report 7 Day Point Prevalence Abstinence | 4 Participants |
| Control Group | Number of Participants Who Report 7 Day Point Prevalence Abstinence | 2 Participants |
Secondary
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.
Time frame: 3 months post-quit attempt (Session 5)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iCOMMIT | Number of Participants Who Report 7 Day Point Prevalence Abstinence | 2 Participants |
| Control Group | Number of Participants Who Report 7 Day Point Prevalence Abstinence | 1 Participants |