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The study investigators will enroll 45 treatment seeking, cigarette smokers with a Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia who will be randomly assigned into three arms of treatment for smoking cessation treatment, receiving either 1. Control: "standard therapy" (n=15), including stepwise monotherapy of nicotine patch or bupropion sustained release, 2. Extended treatment with combination bupropion, nicotine patch, and nicotine lozenge for 6 months (n=15), or 3. Extended treatment with combination bupropion, nicotine patch, and nicotine lozenge for 6 months with home visits (n=15) and phone calls to the home or living facility. During all treatments, participants will receive weekly smoking cessation group counseling, as is standard for smoking cessation treatment. At the time of enrollment, participants will complete a one-study visit lead-in to complete baseline assessments, psychological and medical evaluation, and comprehensive assessment of drug use to determine study eligibility. Once determined to be eligible for the trial, participants will be randomly assigned to one of the treatment arms using a randomization procedure. The "standard therapy" treatment arm, or control group, will receive either nicotine patch taper starting at 21 milligrams (mg) daily, nicotine lozenge as needed, and/or bupropion sustained release at 150mg daily for 3 days, then 150 mg twice a day for a total of 12 weeks. The extended therapy arm will start the nicotine patch at 21mg daily with as needed nicotine lozenge for breakthrough cravings and initiation of bupropion sustained release at 150mg daily for 3 days a week prior to starting nicotine replacement, then 150 mg twice daily for 6 months (as tolerated). The third arm will be identical to the second arm except for the added home visit intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Monotherapy | Other | Treatment as usual starting with one smoking cessation medication plus group therapy. |
|
| Combination Extended Treatment | Experimental | Extended treatment with multiple standard medications plus group therapy. |
|
| Combination Extended Treatment + Home Visits/Calls | Experimental | Extended treatment with multiple standard medications plus group therapy plus home visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination Bupropion + NRTs | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled Carbon Monoxide (CO) as Parts Per Million (PPM) | Weekly measurements of expired carbon monoxide in the units of parts per million (PPM) participants to evaluate abstinence from smoking (a value equal to or less than 3 PPM is considered abstinent). | Measured week 0, 12, and 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Los Angeles Veterans Affairs Medical Center | Los Angeles | California | 90073 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Monotherapy | Treatment as usual starting with one smoking cessation medication plus group therapy. Monotherapy |
| FG001 | Combination Extended Treatment | Extended treatment with multiple standard medications plus group therapy. Combination Bupropion + NRTs Extended Treatment |
| FG002 | Combination Extended Treatment + Home Visits/Calls | Extended treatment with multiple standard medications plus group therapy plus home visits. Combination Bupropion + NRTs Extended Treatment Home Visits & Calls |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Monotherapy | Treatment as usual starting with one smoking cessation medication plus group therapy. Monotherapy |
| BG001 | Combination Extended Treatment | Extended treatment with multiple standard medications plus group therapy. Combination Bupropion + NRTs Extended Treatment |
| 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 | Exhaled Carbon Monoxide (CO) as Parts Per Million (PPM) | Weekly measurements of expired carbon monoxide in the units of parts per million (PPM) participants to evaluate abstinence from smoking (a value equal to or less than 3 PPM is considered abstinent). | Posted | Mean | Standard Deviation | ppm | Measured week 0, 12, and 26 |
|
For the 26 weeks the study was conducted.
Due to the nature of the study, there was not a substantial risk for serious adverse events or mortality. Non serious adverse events were recorded non systematically.
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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 | Standard Monotherapy | Treatment as usual starting with one smoking cessation medication plus group therapy. Monotherapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
Modest sample size lacked power to differentiate between the COMB-EXT groups with/without HV; no control group other than TAU; no motivation to quit rating scale; no biochemical (plasma, salivary, urine) measures taken to ensure abstinence
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arthur Brody | Department of Psychiatry, University of California San Diego | 8585528585 | 3775 | abrody@ucsd.edu |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D006792 | House Calls |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Extended Treatment |
| Other |
|
| Home Visits & Calls | Other |
|
| Monotherapy | Drug |
|
| BG002 | Combination Extended Treatment + Home Visits/Calls | Extended treatment with multiple standard medications plus group therapy plus home visits. Combination Bupropion + NRTs Extended Treatment Home Visits & Calls |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 |
| Combination Extended Treatment + Home Visits/Calls |
Extended treatment with multiple standard medications plus group therapy plus home visits. Combination Bupropion + NRTs Extended Treatment Home Visits & Calls |
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 6 |
| 13 |
| EG001 | Combination Extended Treatment | Extended treatment with multiple standard medications plus group therapy. Combination Bupropion + NRTs Extended Treatment | 0 | 10 | 0 | 10 | 3 | 10 |
| EG002 | Combination Extended Treatment + Home Visits/Calls | Extended treatment with multiple standard medications plus group therapy plus home visits. Combination Bupropion + NRTs Extended Treatment Home Visits & Calls | 0 | 11 | 0 | 11 | 3 | 11 |
| Vivid dreams | Psychiatric disorders | Non-systematic Assessment |
|
| Rash (with the patch) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | Non-systematic Assessment |
|
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