Trial Outcomes & Findings for Smokers' Health Project: Self-Determination and Maintaining Tobacco Abstinence (NCT NCT00178685)

NCT ID: NCT00178685

Last Updated: 2013-02-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 837 participants
• Primary outcome timeframe: 12 months after subject completes intervention.
• Results posted on: 2013-02-15

Participant Flow

Recruitment began in August 2004 and completed in September 2008. Subjects were consented in the research office.

Participant milestones

Measure	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.	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.	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.
Overall Study STARTED	172	324	324
Overall Study COMPLETED	61	120	128
Overall Study NOT COMPLETED	111	204	196

Reasons for withdrawal

Measure	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.	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.	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.
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

Smokers' Health Project: Self-Determination and Maintaining Tobacco Abstinence

Baseline characteristics by cohort

Measure	Community Care n=172 Participants 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.	Extended Autonomy Support (EAS n=324 Participants 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.	Harm Reduction (HR) n=324 Participants 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.	Total n=820 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	163 Participants n=5 Participants	309 Participants n=7 Participants	303 Participants n=5 Participants	775 Participants n=4 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants	45 Participants n=4 Participants
Age Continuous	47.74 years STANDARD_DEVIATION 11.49614 • n=5 Participants	46.27 years STANDARD_DEVIATION 12.14891 • n=7 Participants	48.32 years STANDARD_DEVIATION 11.69470 • n=5 Participants	47.39 years STANDARD_DEVIATION 11.69 • n=4 Participants
Sex: Female, Male Female	98 Participants n=5 Participants	194 Participants n=7 Participants	196 Participants n=5 Participants	488 Participants n=4 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	130 Participants n=7 Participants	128 Participants n=5 Participants	332 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Community Care n=169 Participants 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.	Extended Autonomy Support (EAS n=321 Participants 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.	Harm Reduction (HR) n=318 Participants 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.
12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention.	169 participants	321 participants	318 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Community Care n=169 Participants 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.	Extended Autonomy Support (EAS n=321 Participants 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.	Harm Reduction (HR) n=318 Participants 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.
7 Day Point Prevelence (7DPP)	169 participants	321 participants	318 participants

Adverse Events

Community Care

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Extended Autonomy Support (EAS

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Harm Reduction (HR)

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Community Care n=172 participants at risk 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.	Extended Autonomy Support (EAS n=324 participants at risk 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.	Harm Reduction (HR) n=324 participants at risk 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.
General disorders Death	2.3% 4/172 • Number of events 4	0.93% 3/324 • Number of events 3	1.9% 6/324 • Number of events 6

Other adverse events

Measure	Community Care n=172 participants at risk 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.	Extended Autonomy Support (EAS n=324 participants at risk 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.	Harm Reduction (HR) n=324 participants at risk 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.
Social circumstances Dropped from study after patient quit smoking	0.58% 1/172 • Number of events 1	0.31% 1/324 • Number of events 1	0.00% 0/324
General disorders Patient had adverse event while being treated for MS. Unrelated to smoking study.	0.58% 1/172 • Number of events 1	0.31% 1/324 • Number of events 1	0.00% 0/324

Additional Information

Dr. Geoffrey Williams

University of Rochester

Phone: 585-530-2050

Email: geoffrey_williams@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place