Tobacco Use Disorder
Conditions
Keywords
Self-determination, motivation, adherence, competence, autonomy, tobacco dependence, Tobacco use and dependence, Behavior change
Brief summary
These two studies will examine the role of autonomous motivation in maintained adherence. The first study will determine whether smokers are still abstinent from tobacco 32 months after starting in a previous project (Smoker's Health Study). The purpose of the second study is to determine which of three treatments for tobacco dependence provides the greatest amount of protection from relapsing to smoking after quitting. Specifically, the investigators will determine if extending the length of treatment time focusing on relapse prevention and arranging for support from important others prevents relapse compared to community care. Also, the investigators will determine if providing extended treatment time and support from important others plus providing medications to those that don't want to quit prevents long term relapse compared to just extending the length of treatment time and support from others. Additionally, a sub set of the population will be randomized to using hand held palm devices to recover real-time data assessment during the last 10 months of the project.
Detailed description
These two studies will extend our examination of self-determination theory (SDT) based counseling interventions to the issue of maintained abstinence from tobacco use. Two projects are proposed, both of which build on the results of our current trial. The first is a 32-month follow-up of the smoking status of patients in the preceding trial called the Smoker's Health Study (self-determination, smoking, diet, and health). That SDT intervention (4 counselor visits over 6 months) increased cessation at 6 months relative to community care, and was also effective in increasing 12 month prolonged abstinence, and the results have been reported in two manuscripts (Williams, McGregor, Sharp, Levesque, Kouides, Ryan, and Deci, In press; Williams, McGregor, Sharp, Levesque, Kouides, Ryan, and Deci, 2005). The part of this first project that will be conducted as part of this grant will be to complete 32 month follow-up of smokers in the Smoker's Health Study. The second project is a 3-cell clinical trial called the Smoker's Health Project that will examine two extensions of the current intervention, both of which place greater emphasis on use of, and adherence to, cessation medications. The two arms will be compared to community care. Both arms involve two visits with a physician to discuss medications and side effects. In both interventions, counselors will address medication adherence. The two arms differ in that patients not ready to quit in one arm will receive a smoking reduction approach (with medications) in which they first try to reduce their smoking to half and then attempt cessation. In addition, to place greater emphasis on medications and to examine medication adherence as a mediator of maintained cessation. There will be two major changes in the intervention intended to facilitate long-term maintenance. First, the intervention will extend over 12 months (whereas the current one lasts only 6 months) with meetings during the additional 6 months focusing on maintenance and relapse prevention. Second, at least one family member or best friend of each patient will be encouraged to meet with a counselor to learn how to be more autonomy supportive with the patient around issues related to tobacco. Cessation and maintained abstinence will be examined with logistic regression. The SDT process model of maintained cessation will be tested using structural equation modeling, and cost-effectiveness analyses will be done for the interventions.
Interventions
BEHAVIORALSelf-determination Intervention for Tobacco Dependence
autonomy supported behavioral intervention for tobacco dependent individuals
Sponsors
National Cancer Institute (NCI)
New York State Department of Health
Greater Rochester Area Tobacco Cessation Center
Health Maintenance Consortium
National Institutes of Health (NIH)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Smoking 5 or more cigarettes per day. * 18 years of age or older. * Speak and read English. * Eligible regardless of desire to quit smoking
Exclusion criteria
* Pregnancy * History of psychotic illness other than depression * Life expectancy of less than 24 months * Dementia, or incompetence for medical decision making
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention. | 12 months after subject completes intervention. | The primary outcome measure was 12-month prolonged abstinence (12M-PA) assessed by patient self-report 12-months after the intervention ended. If participant responded that they had not smoked a cigarette, even a puff, in the last 7 days at 12 months post-intervention, and reported date of last cigarette was 365 days or more prior to assessment date, then they were considered to have 12 month prolonged abstinence. A baseline-observation-carried-forward (BOCF)strategy was used for missing data such that those not reporting smoking status 12 months post-intervention were considered smoking. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7 Day Point Prevelence (7DPP) | 12 months after the intervention | Seven-day point prevalence abstinence (7DPP) was assessed by asking: Have you smoked a cigarette, even a puff, in the last 7 days?16 Participants were also asked if they had smoked cigars or pipe, chewed tobacco, or used snuff in the past 7 days, and if they responded yes they were considered tobacco users. |
Countries
United States
Participant flow
Recruitment details
Recruitment began in August 2004 and completed in September 2008. Subjects were consented in the research office.
Participants by arm
| Arm | Count |
|---|---|
| Community Care The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready. | 172 |
| Extended Autonomy Support (EAS The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy. | 324 |
| Harm Reduction (HR) The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping. | 324 |
| Total | 820 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 3 | 3 | 6 |
| Overall Study | Lost to Follow-up | 100 | 187 | 183 |
| Overall Study | Withdrawal by Subject | 8 | 14 | 7 |
Baseline characteristics
| Characteristic | Community Care | Extended Autonomy Support (EAS | Harm Reduction (HR) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 15 Participants | 21 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 163 Participants | 309 Participants | 303 Participants | 775 Participants |
| Age Continuous | 47.74 years STANDARD_DEVIATION 11.49614 | 46.27 years STANDARD_DEVIATION 12.14891 | 48.32 years STANDARD_DEVIATION 11.6947 | 47.39 years STANDARD_DEVIATION 11.69 |
| Sex: Female, Male Female | 98 Participants | 194 Participants | 196 Participants | 488 Participants |
| Sex: Female, Male Male | 74 Participants | 130 Participants | 128 Participants | 332 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 172 | 1 / 324 | 0 / 324 |
| serious Total, serious adverse events | 4 / 172 | 3 / 324 | 6 / 324 |
Outcome results
Primary
12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention.
The primary outcome measure was 12-month prolonged abstinence (12M-PA) assessed by patient self-report 12-months after the intervention ended. If participant responded that they had not smoked a cigarette, even a puff, in the last 7 days at 12 months post-intervention, and reported date of last cigarette was 365 days or more prior to assessment date, then they were considered to have 12 month prolonged abstinence. A baseline-observation-carried-forward (BOCF)strategy was used for missing data such that those not reporting smoking status 12 months post-intervention were considered smoking.
Time frame: 12 months after subject completes intervention.
Population: A baseline-observation-carried-forward (BOCF)strategy was used for missing data such that those not reporting smoking status 12 months post-intervention were considered smoking.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Community Care | 12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention. | 169 participants |
| Extended Autonomy Support (EAS | 12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention. | 321 participants |
| Harm Reduction (HR) | 12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention. | 318 participants |
Secondary
7 Day Point Prevelence (7DPP)
Seven-day point prevalence abstinence (7DPP) was assessed by asking: Have you smoked a cigarette, even a puff, in the last 7 days?16 Participants were also asked if they had smoked cigars or pipe, chewed tobacco, or used snuff in the past 7 days, and if they responded yes they were considered tobacco users.
Time frame: 12 months after the intervention
Population: 820 individuals were randomized to condition, of those, 12 died during the course of the study (all deaths were found to be unrelated to the study). Final analysis number included all those randomized and excluded those who died during the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Community Care | 7 Day Point Prevelence (7DPP) | 169 participants |
| Extended Autonomy Support (EAS | 7 Day Point Prevelence (7DPP) | 321 participants |
| Harm Reduction (HR) | 7 Day Point Prevelence (7DPP) | 318 participants |