Trial Outcomes & Findings for Providing Free Nicotine Patches to Quitline Smokers (NCT NCT01736085)

Last Updated: 2020-02-19

Results Overview

At seven months post enrollment we will conduct a brief telephone survey to assess smoking status. The information obtained will allow us to determine six month prolonged abstinence rates.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3706 participants

Primary outcome timeframe

Seven months post enrollment

Results posted on

2020-02-19

Participant Flow

Participant milestones

Participant milestones
Measure	Material Group Subjects will receive self-help materials	Materials Plus Voucher Subjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches Voucher: Subjects will receive a voucher for nicotine patches. Subjects randomized into the voucher condition will receive a voucher that can be exchanged for two weeks' worth of free starter kit nicotine patches by calling a dedicated phone number (Quit Boost). The voucher will be mailed the day after the screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date.	Materials Plus Patches Subjects will receive self-help materials and a 2 week's worth of nicotine patches Nicotine patches: Subjects will receive nicotine patches directly sent to their home. Subjects randomized into the patch condition will receive two weeks' worth of free starter kit nicotine patches directly. The patches will be mailed directly to their home the day after screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date.	Counseling Subjects will receive up to 5 sessions of telephone counseling Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling	Counseling Plus Voucher Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches. Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling Voucher: Subjects will receive a voucher for nicotine patches. Subjects ra	Counseling Plus Patches Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches. Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling Nicotine patches: Subjects will receive nicotine patches directly sent to their home. Subj
Overall Study STARTED	529	530	793	530	530	794
Overall Study COMPLETED	529	530	793	530	530	794
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

2 people dropped per subjects' request (materials only and patches + materials)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Material Group n=529 Participants Subjects will receive self-help materials	Materials Plus Voucher n=530 Participants Subjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches Voucher: Subjects will receive a voucher for nicotine patches. Subjects randomized into the voucher condition will receive a voucher that can be exchanged for two weeks' worth of free starter kit nicotine patches by calling a dedicated phone number (Quit Boost). The voucher will be mailed the day after the screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date.	Materials Plus Patches n=793 Participants Subjects will receive self-help materials and a 2 week's worth of nicotine patches Nicotine patches: Subjects will receive nicotine patches directly sent to their home. Subjects randomized into the patch condition will receive two weeks' worth of free starter kit nicotine patches directly. The patches will be mailed directly to their home the day after screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date.	Counseling n=530 Participants Subjects will receive up to 5 sessions of telephone counseling Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling	Counseling Plus Voucher n=530 Participants Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches. Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling Voucher: Subjects will receive a voucher for nicotine patches. Subjects ra	Counseling Plus Patches n=794 Participants Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches. Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling Nicotine patches: Subjects will receive nicotine patches directly sent to their home. Subj	Total n=3706 Participants Total of all reporting groups
Age, Customized 18-24 years	55 Participants n=93 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	70 Participants n=4 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	77 Participants n=27 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	62 Participants n=483 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	52 Participants n=36 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	76 Participants n=10 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	392 Participants n=115 Participants • 2 people dropped per subjects' request (materials only and patches + materials)
Age, Customized 25-44 years	203 Participants n=93 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	207 Participants n=4 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	304 Participants n=27 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	211 Participants n=483 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	200 Participants n=36 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	297 Participants n=10 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	1422 Participants n=115 Participants • 2 people dropped per subjects' request (materials only and patches + materials)
Age, Customized 45-64 years	236 Participants n=93 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	217 Participants n=4 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	354 Participants n=27 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	231 Participants n=483 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	245 Participants n=36 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	368 Participants n=10 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	1651 Participants n=115 Participants • 2 people dropped per subjects' request (materials only and patches + materials)
Age, Customized 65+ years	35 Participants n=93 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	36 Participants n=4 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	58 Participants n=27 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	26 Participants n=483 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	33 Participants n=36 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	53 Participants n=10 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	241 Participants n=115 Participants • 2 people dropped per subjects' request (materials only and patches + materials)
Sex: Female, Male Female	279 Participants n=93 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	283 Participants n=4 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	377 Participants n=27 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	244 Participants n=483 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	265 Participants n=36 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	419 Participants n=10 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	1867 Participants n=115 Participants • 2 people dropped per subjects' request (materials only and patches + materials)
Sex: Female, Male Male	250 Participants n=93 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	247 Participants n=4 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	416 Participants n=27 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	286 Participants n=483 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	265 Participants n=36 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	375 Participants n=10 Participants • 2 people dropped per subjects' request (materials only and patches + materials)	1839 Participants n=115 Participants • 2 people dropped per subjects' request (materials only and patches + materials)
Race/Ethnicity, Customized White	288 Participants n=93 Participants	263 Participants n=4 Participants	438 Participants n=27 Participants	301 Participants n=483 Participants	300 Participants n=36 Participants	465 Participants n=10 Participants	2055 Participants n=115 Participants
Race/Ethnicity, Customized Black	70 Participants n=93 Participants	80 Participants n=4 Participants	117 Participants n=27 Participants	59 Participants n=483 Participants	57 Participants n=36 Participants	110 Participants n=10 Participants	493 Participants n=115 Participants
Race/Ethnicity, Customized Hispanic	109 Participants n=93 Participants	94 Participants n=4 Participants	140 Participants n=27 Participants	94 Participants n=483 Participants	122 Participants n=36 Participants	139 Participants n=10 Participants	698 Participants n=115 Participants
Race/Ethnicity, Customized Asian	15 Participants n=93 Participants	22 Participants n=4 Participants	30 Participants n=27 Participants	21 Participants n=483 Participants	9 Participants n=36 Participants	16 Participants n=10 Participants	113 Participants n=115 Participants
Race/Ethnicity, Customized American Indian and Alaska Native	6 Participants n=93 Participants	11 Participants n=4 Participants	12 Participants n=27 Participants	8 Participants n=483 Participants	9 Participants n=36 Participants	10 Participants n=10 Participants	56 Participants n=115 Participants
Race/Ethnicity, Customized Multi-Race	39 Participants n=93 Participants	55 Participants n=4 Participants	52 Participants n=27 Participants	41 Participants n=483 Participants	31 Participants n=36 Participants	51 Participants n=10 Participants	269 Participants n=115 Participants
Race/Ethnicity, Customized Other	2 Participants n=93 Participants	5 Participants n=4 Participants	4 Participants n=27 Participants	6 Participants n=483 Participants	2 Participants n=36 Participants	3 Participants n=10 Participants	22 Participants n=115 Participants
Education <=12	111 Participants n=93 Participants	99 Participants n=4 Participants	132 Participants n=27 Participants	96 Participants n=483 Participants	99 Participants n=36 Participants	123 Participants n=10 Participants	660 Participants n=115 Participants
Education GED/HSD	150 Participants n=93 Participants	148 Participants n=4 Participants	259 Participants n=27 Participants	159 Participants n=483 Participants	152 Participants n=36 Participants	232 Participants n=10 Participants	1100 Participants n=115 Participants
Education Some College	218 Participants n=93 Participants	242 Participants n=4 Participants	323 Participants n=27 Participants	222 Participants n=483 Participants	227 Participants n=36 Participants	339 Participants n=10 Participants	1571 Participants n=115 Participants
Education BS/BA +	50 Participants n=93 Participants	41 Participants n=4 Participants	79 Participants n=27 Participants	53 Participants n=483 Participants	52 Participants n=36 Participants	100 Participants n=10 Participants	375 Participants n=115 Participants
Cigs per day <15	223 Participants n=93 Participants	261 Participants n=4 Participants	348 Participants n=27 Participants	201 Participants n=483 Participants	215 Participants n=36 Participants	330 Participants n=10 Participants	1578 Participants n=115 Participants
Cigs per day <=15	306 Participants n=93 Participants	269 Participants n=4 Participants	445 Participants n=27 Participants	329 Participants n=483 Participants	315 Participants n=36 Participants	464 Participants n=10 Participants	2128 Participants n=115 Participants

PRIMARY outcome

Timeframe: Seven months post enrollment

Population: intent-to-treat; we are looking at the marginal means

At seven months post enrollment we will conduct a brief telephone survey to assess smoking status. The information obtained will allow us to determine six month prolonged abstinence rates.

Outcome measures

Outcome measures
Measure	Usual Care n=1059 Participants no provision of free nicotine replacement therapy (NRT)	Voucher n=1060 Participants Free nicotine replacement through a voucher system	Patches n=1587 Participants nicotine replacement sent directly
Number of Participants With Six Months Prolonged Abstinence	61 Participants	76 Participants	151 Participants

SECONDARY outcome

Timeframe: Two months post enrollment

Population: those evaluated at 2-months; we are looking at the marginal means

At the follow up evaluation, subjects will be asked if they have made a quit attempt that lasted at least 24 hours.