Tobacco Use Cessation, Tobacco Use Disorder
Conditions
Keywords
tobacco
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALstage-tailored intervention
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.
Sponsors
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7 Day Point Prevalence of Cigarette Abstinence | 3 mo, 6 mo, 12 mo, and 18 mo post-baseline |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Usual care provided NRT during hospitalization with brief cessation advice. | 111 |
| 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. | 113 |
| Total | 224 |
Baseline characteristics
| Characteristic | Control | Brief Treatment | Total |
|---|---|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 14.1 | 39.9 years STANDARD_DEVIATION 13.5 | 39.9 years STANDARD_DEVIATION 14 |
| Sex/Gender, Customized Female | 71 participants | 63 participants | 134 participants |
| Sex/Gender, Customized Male | 36 participants | 48 participants | 84 participants |
| Sex/Gender, Customized Other | 4 participants | 2 participants | 6 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 111 | 2 / 113 |
| other Total, other adverse events | 0 / 111 | 0 / 113 |
| serious Total, serious adverse events | 0 / 111 | 0 / 113 |
Outcome results
Primary
7 Day Point Prevalence of Cigarette Abstinence
Time frame: 3 mo, 6 mo, 12 mo, and 18 mo post-baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | 7 Day Point Prevalence of Cigarette Abstinence | 6 month | 6 Participants |
| Control | 7 Day Point Prevalence of Cigarette Abstinence | 12 month | 10 Participants |
| Control | 7 Day Point Prevalence of Cigarette Abstinence | 18 month | 7 Participants |
| Control | 7 Day Point Prevalence of Cigarette Abstinence | 3 month | 3 Participants |
| Brief Treatment | 7 Day Point Prevalence of Cigarette Abstinence | 3 month | 14 Participants |
| Brief Treatment | 7 Day Point Prevalence of Cigarette Abstinence | 6 month | 14 Participants |
| Brief Treatment | 7 Day Point Prevalence of Cigarette Abstinence | 18 month | 18 Participants |
| Brief Treatment | 7 Day Point Prevalence of Cigarette Abstinence | 12 month | 18 Participants |
Comparison: To test the primary hypothesis, we ran a generalized estimating equation model with logit link function (PROC GENMOD in SAS version 9.2), to examine abstinence versus smoking status at the 3- through 18-month follow-ups by condition.p-value: 0.01895% CI: [1.22, 8.14]generalized estimating equation model