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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23DA018691-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of California, San Francisco | OTHER |
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The purpose of this study is to test in a randomized clinical trial a series of hypotheses concerning the efficacy of an extended expert-system intervention plus nicotine replacement therapy (NRT) for treating tobacco dependence among patients hospitalized on a smoke-free psychiatric unit.
It is hypothesized that the intervention will be more effective than the enhanced standard care control condition (on-unit NRT with self-help brochure) in producing biochemically verified abstinence from cigarettes at 3-, 6-, 12-, and 18-months follow up. Additionally, intervention participants will exhibit greater stage progression, commitment to abstinence, and delay in relapse to smoking following hospital discharge, factors predictive of future success with quitting smoking. Smoking cessation treatments have been shown to be highly cost-effective with the general population of smokers, and cost is likely to be a consideration in efforts to incorporate additional services into an inpatient psychiatric setting. Therefore, a secondary specific aim is to model the cost-effectiveness of the smoking cessation intervention. Intervention efficacy will be examined in a university-based psychiatric inpatient unit. A smaller pilot study will examine translation of the intervention to a county hospital serving a more diversified patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enhanced usual care control | No Intervention | NRT during hospitalization with brief advice to stay quit once discharged | |
| stage-tailored intervention | Experimental | NRT during hospitalization with brief advice to stay quit once discharged plus a computer-delivered stage-tailored smoking cessation intervention with manual and counseling plus 10-weeks of nicotine patch available post-hospitalization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stage-tailored intervention | Behavioral | This intervention consists of nicotine patch therapy during hospitalization; a stage-based self-help manual; an individualized, expert-system, feedback report at intake, 3 months and 6 months post-hospitalization with carbon copies sent to participants' outpatient clinicians; and an individual 30-min smoking cessation counseling sessions during hospitalization. Additionally, up to 10 weeks of nicotine patch is provided to intervention participants intending to stay quit following hospital discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| 7 Day Point Prevalence of Cigarette Abstinence | 3 mo, 6 mo, 12 mo, and 18 mo post-baseline |
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Inclusion Criteria: Men and women over 18 years of age hospitalized on an inpatient psychiatric unit who report smoking at least 5 cigarettes per day; smoking at least 100 cigarettes in one's lifetime, residing in the San Francisco Bay Area with no plan to relocate outside of the area in the next 18 months, and access to a telephone for scheduling follow up assessments.
Exclusion Criteria: Dementia or other brain injury precluding ability to participate; non-English speaking; severe agitation, psychosis, or hostility; and medical contraindications to nicotine replacement therapy (NRT). Recruitment of acutely psychotic, manic, or hostile patients will be delayed until there is significant reduction of these symptoms. Medical contraindications are: myocardial infarction in the preceding 3 months, unstable angina pectoris, liver or kidney disease, current pregnancy or breast feeding, allergies to adhesives, or other medical conditions that the medical team deems incompatible with NRT use.
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| Name | Affiliation | Role |
|---|---|---|
| Judith Prochaska | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital | San Francisco | California | 94110 | United States | ||
| Langley Porter Psychiatric Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26528651 | Result | Barnett PG, Wong W, Jeffers A, Hall SM, Prochaska JJ. Cost-effectiveness of smoking cessation treatment initiated during psychiatric hospitalization: analysis from a randomized, controlled trial. J Clin Psychiatry. 2015 Oct;76(10):e1285-91. doi: 10.4088/JCP.14m09016. |
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no plan to make individual participant data available
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Adult smokers (N=224) were recruited between July 2006 and December 2008 from the adult inpatient psychiatry unit at the Langley Porter Psychiatric Institute (LPPI) located on the University of California, San Francisco (UCSF) medical school campus.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Usual care provided NRT during hospitalization with brief cessation advice. |
| FG001 | Brief Treatment | The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Usual care provided NRT during hospitalization with brief cessation advice. |
| BG001 | Brief Treatment | The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 of Cigarette Abstinence | Posted | Count of Participants | Participants | 3 mo, 6 mo, 12 mo, and 18 mo post-baseline |
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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 | 1: Enhanced Standard Care Control | enhanced standard care control | 2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Prochaska, PhD, MPH; Associate Professor | Stanord University | 650-724-3608 | JPro@stanford.edu |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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|
| San Francisco |
| California |
| 94143 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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|
| 111 |
| 0 |
| 111 |
| 0 |
| 111 |
| EG001 | 2: Intervention | intervention Tobacco Use Cessation: This intervention consists of nicotine patch therapy during hospitalization; a stage-based self-help manual; an individualized, expert-system, feedback report at intake, 3 months and 6 months post-hospitalization with carbon copies sent to participants' outpatient clinicians; and an individual 30-min smoking cessation counseling sessions during hospitalization. Additionally, up to 10 weeks of nicotine patch is provided to intervention participants intending to stay quit following hospital discharge. | 2 | 113 | 0 | 113 | 0 | 113 |
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| D001523 |
| Mental Disorders |