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| Name | Class |
|---|---|
| Hennepin County Medical Center, Minneapolis | OTHER |
| Brown University | OTHER |
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This is a smoking cessation study that will enroll smokers who have been diagnosed with a severe mental illness. The study will use a combination of intensive tobacco treatment counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting smoking over the course of six months.
At the baseline measurement visit, participants will be asked to complete a survey and an interview. They will be randomly assigned to either the intervention or control group. Both groups will receive a smoking cessation manual and list of resources. The intervention group will also receive smoking cessation counseling and nicotine replacement therapy. Both groups will be seen for in-person assessments again at 8 weeks and 6 months post baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges. |
|
| Control | Other | Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine patch | Drug | Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use |
| Measure | Description | Time Frame |
|---|---|---|
| 7-Day Point Prevalence Abstinence | To determine the number of patients in the intervention and control conditions who achieve 7-day point prevalence abstinence at 8 weeks and 6 months after enrollment. | 8 weeks and 6 months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Quit Attempts | To determine the number of patients in the intervention and control condition who achieve self-reported minimum 24 hour quit attempts. | 8 weeks and 6 months post baseline |
| Smoking Reduction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harry Lando, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33593332 | Derived | Busch AM, Nederhoff DM, Dunsiger SI, Japuntich SJ, Chrastek M, Adkins-Hempel M, Rinehart LM, Lando H. Chronic care treatment for smoking cessation in patients with serious mental illness: a pilot randomized trial. BMC Psychiatry. 2021 Feb 17;21(1):104. doi: 10.1186/s12888-021-03113-5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges. Nicotine patch: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use Nicotine lozenge: Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use Therapy: In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community |
| FG001 | Control | Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation. Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges. Nicotine patch: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use Nicotine lozenge: Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use Therapy: In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | 7-Day Point Prevalence Abstinence | To determine the number of patients in the intervention and control conditions who achieve 7-day point prevalence abstinence at 8 weeks and 6 months after enrollment. | Posted | Count of Participants | Participants | 8 weeks and 6 months post baseline |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges. Nicotine patch: Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use Nicotine lozenge: Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use Therapy: In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increased coughing following smoking cessation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harry Lando, PhD | University of Minnesota | 612-624-1877 | lando001@umn.edu |
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| 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 | Jul 16, 2019 | May 3, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 15, 2019 | May 3, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000073865 | Cigarette Smoking |
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D003865 | Depressive Disorder, Major |
| D001714 | Bipolar Disorder |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D013812 | Therapeutics |
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The outcomes assessor will not be made aware of the participant's study status, although it may become obvious during the assessments.
| Nicotine lozenge | Drug | Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use |
|
| Therapy | Behavioral | In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase |
|
| Information | Other | Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community |
|
To determine the mean reduction in cigarettes per day in the intervention and control conditions.
| 8 weeks and 6 months post baseline |
| BG001 | Control | Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation. Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Control | Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation. Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community |
|
|
| Secondary | Quit Attempts | To determine the number of patients in the intervention and control condition who achieve self-reported minimum 24 hour quit attempts. | Posted | Count of Participants | Participants | 8 weeks and 6 months post baseline |
|
|
|
| Secondary | Smoking Reduction | To determine the mean reduction in cigarettes per day in the intervention and control conditions. | Posted | Mean | Standard Deviation | cigarettes per day | 8 weeks and 6 months post baseline |
|
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| 0 |
| 19 |
| 0 |
| 19 |
| 1 |
| 19 |
| EG001 | Control | Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation. Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community | 0 | 19 | 0 | 19 | 0 | 19 |
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| D064424 |
| Tobacco Use |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D000068105 | Bipolar and Related Disorders |