Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months post-quit attempt (Session 5) |
| Number of Participants Who Report 30 Day Point Prevalence Abstinence |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean C Beckham, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27706 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
One participant was deemed ineligible to participate in the study prior to randomization because that participant couldn't read or write English.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | iCOMMIT | Components include:
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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 |
|
|
| 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. |
|
| 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. |
|
|
| 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. |
|
| 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. |
|
|
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. |
| 3 months post-quit attempt (Session 5) |
| 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. | 6 months post-quit attempt (Session 6) |
| 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. | 6 months post-quit attempt (Session 6) |
| FG001 | Control Group | Components include:
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | iCOMMIT | Components include:
|
| BG001 | Control Group | Components include:
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 6 month follow-up |
|
|
| ||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 6 month follow-up |
| ||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 3 months post-quit attempt (Session 5) |
| ||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 3 months post-quit attempt (Session 5) |
| ||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 6 months post-quit attempt (Session 6) |
| ||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 6 months post-quit attempt (Session 6) |
|
Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | iCOMMIT | Components include:
| 0 | 21 | 2 | 21 | 13 | 21 |
| EG001 | Control Group | Components include:
| 0 | 13 | 3 | 13 | 12 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Mouth and/or throat irritation | General disorders | Non-systematic Assessment | study-related |
| |
| Altercation with police | Social circumstances | Non-systematic Assessment |
| ||
| Jitteriness, shakiness | Nervous system disorders | Non-systematic Assessment | Related to bupropion use |
| |
| Sleep problems and/or nightmares | Psychiatric disorders | Non-systematic Assessment |
| ||
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Related to nicotine patch use |
| |
| Sweating | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Related to quitting smoking |
| |
| Family violence | Social circumstances | Non-systematic Assessment | Not related to study participation |
| |
| Rape | Social circumstances | Non-systematic Assessment | Not related to study participation |
| |
| Increased psychiatric symptoms | Psychiatric disorders | Non-systematic Assessment | Not related to study procedures, includes increased hallucinations and/or depressed mood |
| |
| Nausea, upset stomach | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Flu | General disorders | Non-systematic Assessment | Not study related |
| |
| dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Car accident | Social circumstances | Non-systematic Assessment |
| ||
| Death in family | Social circumstances | Non-systematic Assessment |
| ||
| Eye infection | Eye disorders | Non-systematic Assessment |
| ||
| Increased foot pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Related to pre-existing medical conditions |
| |
| Benign tumor removed from lung | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Pre-existing medical condition |
| |
| Dental surgery | Surgical and medical procedures | Non-systematic Assessment | Related to pre-existing medical condition |
| |
| Pain | General disorders | Non-systematic Assessment | Related to pre-existing medical condition |
| |
| Increased seizures | Nervous system disorders | Non-systematic Assessment | Related to pre-existing medical condition |
| |
| Swelling in leg | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Related to pre-existing medical condition |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Kirby | Duke University School of Medicine | 919-286-0411 | 175526 | angela.kirby@duke.edu |
| Jun 19, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
Not provided
Not provided
| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| D000074164 | Nicotine Chewing Gum |
| D057968 | Transdermal Patch |
| D009330 | Nebulizers and Vaporizers |
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D061485 | Tobacco Use Cessation Devices |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D004864 | Equipment and Supplies |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|