Trial Outcomes & Findings for Identifying Effective Treatment for Veterans Unwilling to Quit Smoking (NCT NCT04061720)

Last Updated: 2026-08-31

Results Overview

Participants who self-report no smoking for the past 7 days at the assessment endpoint (2-year follow-up) will be considered to meet criteria for 7-Day Point-Prevalence Abstinence. Participants who report any smoking in the past 7 days (at the 2 year follow-up) will be considered to be relapsed (smoking). Participants who self-report no smoking for the past 7 days at 2-year follow-up were mailed a self-administered saliva sample collection kit. A saliva cotinine level of 10 ng/mL was used as the cutoff to determine smoking abstinence.

Recruitment status

COMPLETED

Study phase

Target enrollment

502 participants

Primary outcome timeframe

2 years

Results posted on

2026-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	Enhanced Chronic Care Enhanced Chronic Care provides ongoing, phone-based motivational interventions and interpersonal support to promote readiness to quit, with facilitated access to evidence-based smoking treatment.	Standard Care Standard Care provides phone-based brief advice to quit once per year.
Overall Study STARTED	249	253
Overall Study COMPLETED	175	187
Overall Study NOT COMPLETED	74	66

Reasons for withdrawal

Reasons for withdrawal
Measure	Enhanced Chronic Care Enhanced Chronic Care provides ongoing, phone-based motivational interventions and interpersonal support to promote readiness to quit, with facilitated access to evidence-based smoking treatment.	Standard Care Standard Care provides phone-based brief advice to quit once per year.
Overall Study Withdrawal by Subject	36	36
Overall Study Death	19	23
Overall Study Lost to Follow-up	19	7

Baseline Characteristics

Identifying Effective Treatment for Veterans Unwilling to Quit Smoking

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enhanced Chronic Care n=249 Participants Enhanced Chronic Care provides ongoing, phone-based motivational interventions and interpersonal support to promote readiness to quit, with facilitated access to evidence-based smoking treatment.	Standard Care n=253 Participants Standard Care provides phone-based brief advice to quit once per year.	Total n=502 Participants Total of all reporting groups
Age, Continuous	62.55 Years STANDARD_DEVIATION 11.81 • n=14 Participants	62.99 Years STANDARD_DEVIATION 10.17 • n=36 Participants	62.77 Years STANDARD_DEVIATION 11.02 • n=324 Participants
Sex: Female, Male Female	18 Participants n=14 Participants	19 Participants n=36 Participants	37 Participants n=324 Participants
Sex: Female, Male Male	231 Participants n=14 Participants	234 Participants n=36 Participants	465 Participants n=324 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=14 Participants	3 Participants n=36 Participants	4 Participants n=324 Participants
Race (NIH/OMB) Asian	1 Participants n=14 Participants	0 Participants n=36 Participants	1 Participants n=324 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants	0 Participants n=36 Participants	0 Participants n=324 Participants
Race (NIH/OMB) Black or African American	44 Participants n=14 Participants	41 Participants n=36 Participants	85 Participants n=324 Participants
Race (NIH/OMB) White	198 Participants n=14 Participants	202 Participants n=36 Participants	400 Participants n=324 Participants
Race (NIH/OMB) More than one race	4 Participants n=14 Participants	3 Participants n=36 Participants	7 Participants n=324 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=14 Participants	4 Participants n=36 Participants	5 Participants n=324 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=14 Participants	5 Participants n=36 Participants	8 Participants n=324 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	244 Participants n=14 Participants	246 Participants n=36 Participants	490 Participants n=324 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=14 Participants	2 Participants n=36 Participants	4 Participants n=324 Participants
Cigarettes per day	16.82 Cigarettes smoked per day STANDARD_DEVIATION 9.25 • n=14 Participants	16.83 Cigarettes smoked per day STANDARD_DEVIATION 8.65 • n=36 Participants	16.83 Cigarettes smoked per day STANDARD_DEVIATION 8.95 • n=324 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Enhanced Chronic Care n=230 Participants Enhanced Chronic Care provides ongoing, phone-based motivational interventions and interpersonal support to promote readiness to quit, with facilitated access to evidence-based smoking treatment.	Standard Care n=230 Participants Standard Care provides phone-based brief advice to quit once per year.
7-Day Point-Prevalence Abstinence Self-report · Abstinent	45 Participants	38 Participants
7-Day Point-Prevalence Abstinence Self-report · Smoking	185 Participants	192 Participants
7-Day Point-Prevalence Abstinence Biochemically verified · Abstinent	21 Participants	21 Participants
7-Day Point-Prevalence Abstinence Biochemically verified · Smoking	209 Participants	209 Participants

SECONDARY outcome

Timeframe: 2 years

Cessation treatment use will be defined as making at least one treatment contact (initiating at least 1 cessation treatment call with reach coded as a binary outcome: use vs. no use).

Outcome measures

Outcome measures
Measure	Enhanced Chronic Care n=230 Participants Enhanced Chronic Care provides ongoing, phone-based motivational interventions and interpersonal support to promote readiness to quit, with facilitated access to evidence-based smoking treatment.	Standard Care n=230 Participants Standard Care provides phone-based brief advice to quit once per year.
Initiating at Least 1 Cessation Treatment Call	82 Participants	28 Participants

Adverse Events

Enhanced Chronic Care

Serious events: 0 serious events

Other events: 4 other events

Deaths: 19 deaths

Standard Care

Serious events: 0 serious events

Other events: 3 other events

Deaths: 23 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Enhanced Chronic Care n=158 participants at risk；n=249 participants at risk Enhanced Chronic Care provides ongoing, phone-based motivational interventions and interpersonal support to promote readiness to quit, with facilitated access to evidence-based smoking treatment.	Standard Care n=30 participants at risk；n=253 participants at risk Standard Care provides phone-based brief advice to quit once per year.
Skin and subcutaneous tissue disorders Skin rash, irritation, or swelling	1.9% 3/158 • Full two years of study enrollment All-cause Mortality and Serious Adverse Events assessed for all enrolled participants. Adverse Events monitored and assessed only for participants who entered tobacco treatment and received nicotine replacement therapy (158 in Enhanced Chronic Care and 30 in Standard Care).	3.3% 1/30 • Full two years of study enrollment All-cause Mortality and Serious Adverse Events assessed for all enrolled participants. Adverse Events monitored and assessed only for participants who entered tobacco treatment and received nicotine replacement therapy (158 in Enhanced Chronic Care and 30 in Standard Care).
Gastrointestinal disorders Persistent Indigestion	1.9% 3/158 • Full two years of study enrollment All-cause Mortality and Serious Adverse Events assessed for all enrolled participants. Adverse Events monitored and assessed only for participants who entered tobacco treatment and received nicotine replacement therapy (158 in Enhanced Chronic Care and 30 in Standard Care).	3.3% 1/30 • Full two years of study enrollment All-cause Mortality and Serious Adverse Events assessed for all enrolled participants. Adverse Events monitored and assessed only for participants who entered tobacco treatment and received nicotine replacement therapy (158 in Enhanced Chronic Care and 30 in Standard Care).
General disorders Insomnia, vivid dreams	0.63% 1/158 • Full two years of study enrollment All-cause Mortality and Serious Adverse Events assessed for all enrolled participants. Adverse Events monitored and assessed only for participants who entered tobacco treatment and received nicotine replacement therapy (158 in Enhanced Chronic Care and 30 in Standard Care).	6.7% 2/30 • Full two years of study enrollment All-cause Mortality and Serious Adverse Events assessed for all enrolled participants. Adverse Events monitored and assessed only for participants who entered tobacco treatment and received nicotine replacement therapy (158 in Enhanced Chronic Care and 30 in Standard Care).

Additional Information

Principal Investigator

William S Middleton Memorial VA Hospital

Phone: 608-280-2213

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place