Trial Outcomes & Findings for Evaluation of National Cancer Institute (NCI) Smoking Intervention Resources (NCT NCT01342523)
NCT ID: NCT01342523
Last Updated: 2015-10-14
Results Overview
Abstinence will be defined as 7-day point prevalence.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1034 participants
Primary outcome timeframe
Measured after the 3 month follow up assessment
Results posted on
2015-10-14
Participant Flow
The recruitment period ran from November 28, 2011 through March 26, 2013. All study participants were recruited through the portal to the smokefree.gov website.
Prior to randomization, potential participants were asked to make a "confirmation" call to an automated answering system to confirm willingness to perform study procedures. The call was intended to increase the likelihood that individuals would take treatment and follow-up calls. Randomization occurred immediately after the confirmation call.
Participant milestones
| Measure |
No CIS/No Loz/No Email/Lite Website/Brief Booklet
|
CIS/No Loz/No Email/Lite Website/Brief Booklet
|
no CIS/Loz/No Email/Lite Website/Brief Booklet
|
No CIS/no Loz/Email/Lite Website/Brief Booklet
|
No CIS/No Loz/No Email/Full Website/Brief Booklet
|
No CIS/No Loz/No Email/Lite Website/Full Booklet
|
CIS/Loz/No Email/Lite Website/Brief Booklet
|
CIS/No Loz/Emails/Lite Website/Brief Booklet
|
CIS/No Loz/no Email/Full Website/Brief Booklet
|
CIS/No Loz/no Email/Lite Website/Full Booklet
|
No CIS/Loz/Emails/Lite Website/Brief Booklet
|
No CIS/Loz/No Emails/Lite Website/Full Booklet
|
No CIS/Loz/No Emails/Full Website/Lite Booklet
|
no CIS/no Loz/Emails/Full Website/Brief Booklet
|
no CIS/no Loz/Emails/Lite Web/Full Booklet
|
no CIS/no Loz/no Email/Full Website/Full Booklet
|
CIS/Loz/Emails/Lite Website/Brief Booklet
|
CIS/Loz/no Email/Full Website/Brief Booklet
|
CIS/Loz/no Email/Lite Website/Full Booklet
|
CIS/no Loz/Emails/Full Website/Brief Booklet
|
CIS/no Loz/Emails/Lite Website/Full Booklet
|
CIS/no Loz/no Email/Full Website/Full Booklet
|
No CIS/Loz/Emails/Full Website/Brief Booklet
|
No CIS/Loz/Emails/Lite Website/Full Booklet
|
No CIS/Loz/no Emails/Full Website/Full Booklet
|
no CIS/no Loz/Emails/Full Website/Full Booklet
|
CIS/Loz/Emails/Full Website/Brief Booklet
|
CIS/Loz/Emails/Lite Website/Full Booklet
|
No CIS/Loz/Emails/Full Website/Full Booklet
|
CIS/no Loz/Emails/Full Website/Full Booklet
|
CIS/Loz/no Emails/Full Website/Full Booklet
|
CIS/Loz/Emails/Full Website/Full Booklet
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
32
|
36
|
33
|
36
|
36
|
22
|
27
|
28
|
28
|
38
|
38
|
39
|
38
|
38
|
32
|
29
|
27
|
21
|
27
|
29
|
30
|
36
|
36
|
37
|
38
|
34
|
31
|
35
|
29
|
31
|
28
|
|
Overall Study
COMPLETED
|
34
|
32
|
36
|
32
|
36
|
36
|
22
|
27
|
28
|
28
|
38
|
36
|
39
|
36
|
37
|
32
|
28
|
27
|
21
|
27
|
29
|
30
|
36
|
35
|
36
|
36
|
33
|
30
|
34
|
28
|
30
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
2
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
1
|
1
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of National Cancer Institute (NCI) Smoking Intervention Resources
Baseline characteristics by cohort
| Measure |
No CIS/No Loz/No Email/Lite Website/Brief Booklet
n=35 Participants
|
CIS/No Loz/No Email/Lite Website/Brief Booklet
n=32 Participants
|
no CIS/Loz/No Email/Lite Website/Brief Booklet
n=36 Participants
|
No CIS/no Loz/Email/Lite Website/Brief Booklet
n=33 Participants
|
No CIS/No Loz/No Email/Full Website/Brief Booklet
n=36 Participants
|
No CIS/No Loz/No Email/Lite Website/Full Booklet
n=36 Participants
|
CIS/Loz/No Email/Lite Website/Brief Booklet
n=22 Participants
|
CIS/No Loz/Emails/Lite Website/Brief Booklet
n=27 Participants
|
CIS/No Loz/no Email/Full Website/Brief Booklet
n=28 Participants
|
CIS/No Loz/no Email/Lite Website/Full Booklet
n=28 Participants
|
No CIS/Loz/Emails/Lite Website/Brief Booklet
n=38 Participants
|
No CIS/Loz/No Emails/Lite Website/Full Booklet
n=38 Participants
|
No CIS/Loz/No Emails/Full Website/Lite Booklet
n=39 Participants
|
no CIS/no Loz/Emails/Full Website/Brief Booklet
n=38 Participants
|
no CIS/no Loz/Emails/Lite Web/Full Booklet
n=38 Participants
|
no CIS/no Loz/no Email/Full Website/Full Booklet
n=32 Participants
|
CIS/Loz/Emails/Lite Website/Brief Booklet
n=29 Participants
|
CIS/Loz/no Email/Full Website/Brief Booklet
n=27 Participants
|
CIS/Loz/no Email/Lite Website/Full Booklet
n=21 Participants
|
CIS/no Loz/Emails/Full Website/Brief Booklet
n=27 Participants
|
CIS/no Loz/Emails/Lite Website/Full Booklet
n=29 Participants
|
CIS/no Loz/no Email/Full Website/Full Booklet
n=30 Participants
|
No CIS/Loz/Emails/Full Website/Brief Booklet
n=36 Participants
|
No CIS/Loz/Emails/Lite Website/Full Booklet
n=36 Participants
|
No CIS/Loz/no Emails/Full Website/Full Booklet
n=37 Participants
|
no CIS/no Loz/Emails/Full Website/Full Booklet
n=38 Participants
|
CIS/Loz/Emails/Full Website/Brief Booklet
n=34 Participants
|
CIS/Loz/Emails/Lite Website/Full Booklet
n=31 Participants
|
No CIS/Loz/Emails/Full Website/Full Booklet
n=35 Participants
|
CIS/no Loz/Emails/Full Website/Full Booklet
n=29 Participants
|
CIS/Loz/no Emails/Full Website/Full Booklet
n=31 Participants
|
CIS/Loz/Emails/Full Website/Full Booklet
n=28 Participants
|
Total
n=1034 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
5 Participants
n=384 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
26 Participants
n=24 Participants
|
27 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
38 Participants
n=42 Participants
|
38 Participants
n=42 Participants
|
37 Participants
n=36 Participants
|
37 Participants
n=36 Participants
|
37 Participants
n=24 Participants
|
32 Participants
n=135 Participants
|
28 Participants
n=136 Participants
|
25 Participants
n=44 Participants
|
21 Participants
n=667 Participants
|
27 Participants
n=7 Participants
|
29 Participants
n=6 Participants
|
27 Participants
n=10 Participants
|
36 Participants
n=14 Participants
|
35 Participants
n=4 Participants
|
35 Participants
n=4 Participants
|
37 Participants
n=4 Participants
|
33 Participants
n=26 Participants
|
29 Participants
n=12 Participants
|
35 Participants
n=206 Participants
|
28 Participants
n=12 Participants
|
29 Participants
n=12 Participants
|
27 Participants
n=12 Participants
|
1008 Participants
n=384 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=26 Participants
|
2 Participants
n=12 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
21 Participants
n=384 Participants
|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 13.117 • n=5 Participants
|
41.97 years
STANDARD_DEVIATION 12.124 • n=7 Participants
|
39.47 years
STANDARD_DEVIATION 11.661 • n=5 Participants
|
40.58 years
STANDARD_DEVIATION 13.709 • n=4 Participants
|
39.89 years
STANDARD_DEVIATION 12.132 • n=21 Participants
|
39.92 years
STANDARD_DEVIATION 13 • n=10 Participants
|
40.5 years
STANDARD_DEVIATION 11.859 • n=115 Participants
|
38.52 years
STANDARD_DEVIATION 14.091 • n=24 Participants
|
37.71 years
STANDARD_DEVIATION 13.160 • n=42 Participants
|
38.11 years
STANDARD_DEVIATION 13.076 • n=42 Participants
|
39 years
STANDARD_DEVIATION 12.192 • n=42 Participants
|
39.16 years
STANDARD_DEVIATION 10.812 • n=42 Participants
|
36.03 years
STANDARD_DEVIATION 11.957 • n=36 Participants
|
39.47 years
STANDARD_DEVIATION 12.967 • n=36 Participants
|
38.18 years
STANDARD_DEVIATION 11.925 • n=24 Participants
|
40.56 years
STANDARD_DEVIATION 11.007 • n=135 Participants
|
42.31 years
STANDARD_DEVIATION 13.134 • n=136 Participants
|
43.04 years
STANDARD_DEVIATION 12.738 • n=44 Participants
|
35.76 years
STANDARD_DEVIATION 12.373 • n=667 Participants
|
39.26 years
STANDARD_DEVIATION 10.376 • n=7 Participants
|
37.79 years
STANDARD_DEVIATION 10.115 • n=6 Participants
|
40.37 years
STANDARD_DEVIATION 13.433 • n=10 Participants
|
38.81 years
STANDARD_DEVIATION 11.112 • n=14 Participants
|
42.97 years
STANDARD_DEVIATION 13.716 • n=4 Participants
|
38.92 years
STANDARD_DEVIATION 13.215 • n=4 Participants
|
40.32 years
STANDARD_DEVIATION 11.242 • n=4 Participants
|
38.47 years
STANDARD_DEVIATION 12.310 • n=26 Participants
|
37.77 years
STANDARD_DEVIATION 13.386 • n=12 Participants
|
36.91 years
STANDARD_DEVIATION 10.441 • n=206 Participants
|
35.62 years
STANDARD_DEVIATION 12.754 • n=12 Participants
|
38.23 years
STANDARD_DEVIATION 13.674 • n=12 Participants
|
42.54 years
STANDARD_DEVIATION 12.96 • n=12 Participants
|
39.28 years
STANDARD_DEVIATION 12.343 • n=384 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
19 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
25 Participants
n=36 Participants
|
21 Participants
n=36 Participants
|
26 Participants
n=24 Participants
|
23 Participants
n=135 Participants
|
23 Participants
n=136 Participants
|
21 Participants
n=44 Participants
|
13 Participants
n=667 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=6 Participants
|
19 Participants
n=10 Participants
|
23 Participants
n=14 Participants
|
28 Participants
n=4 Participants
|
28 Participants
n=4 Participants
|
25 Participants
n=4 Participants
|
18 Participants
n=26 Participants
|
24 Participants
n=12 Participants
|
22 Participants
n=206 Participants
|
20 Participants
n=12 Participants
|
25 Participants
n=12 Participants
|
22 Participants
n=12 Participants
|
703 Participants
n=384 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
8 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
14 Participants
n=36 Participants
|
17 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
9 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=6 Participants
|
11 Participants
n=10 Participants
|
13 Participants
n=14 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=4 Participants
|
16 Participants
n=26 Participants
|
7 Participants
n=12 Participants
|
13 Participants
n=206 Participants
|
9 Participants
n=12 Participants
|
6 Participants
n=12 Participants
|
6 Participants
n=12 Participants
|
331 Participants
n=384 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
32 participants
n=7 Participants
|
36 participants
n=5 Participants
|
33 participants
n=4 Participants
|
36 participants
n=21 Participants
|
36 participants
n=10 Participants
|
22 participants
n=115 Participants
|
27 participants
n=24 Participants
|
28 participants
n=42 Participants
|
28 participants
n=42 Participants
|
38 participants
n=42 Participants
|
38 participants
n=42 Participants
|
39 participants
n=36 Participants
|
38 participants
n=36 Participants
|
38 participants
n=24 Participants
|
32 participants
n=135 Participants
|
29 participants
n=136 Participants
|
27 participants
n=44 Participants
|
21 participants
n=667 Participants
|
27 participants
n=7 Participants
|
29 participants
n=6 Participants
|
30 participants
n=10 Participants
|
36 participants
n=14 Participants
|
36 participants
n=4 Participants
|
37 participants
n=4 Participants
|
38 participants
n=4 Participants
|
34 participants
n=26 Participants
|
31 participants
n=12 Participants
|
35 participants
n=206 Participants
|
29 participants
n=12 Participants
|
31 participants
n=12 Participants
|
28 participants
n=12 Participants
|
1034 participants
n=384 Participants
|
PRIMARY outcome
Timeframe: Measured after the 3 month follow up assessmentPopulation: "Intention to treat (ITT)
Abstinence will be defined as 7-day point prevalence.
Outcome measures
| Measure |
Cancer Information Service Counseling ("CIS")
n=453 Participants
Participants in this intervention group received telephone quitline counseling from the Cancer Information Service (CIS). These proactive calls initiated by CIS included an initial call (30 min), occurring within 3 days of enrollment, plus 4 additional counseling calls (up to 15 min each) scheduled to occur on the quit day or the day after, and then weekly for the next 3 weeks. The content of the counseling calls focused initially on motivating quitting and then setting a quit date, providing support, building self-efficacy, and skill training. The CIS intervention group will be compared to a "No CIS" group. The original randomization plan called for approximately half of the total sample of 1034 participants to be randomized to this intervention group (CIS) and the other half to the No CIS intervention group. However, due to a problem in the electronic transfer of data from the research coordinating site to CIS, 453 participants were randomized to CIS and 581 to the "No CIS" group.
|
No Cancer Information Service Counseling ("No CIS")
n=581 Participants
Participants in this intervention group did not receive telephone quitline counseling from the Cancer Information Service (CIS). This intervention group will be compared to an intervention group that did receive telephone quitline counseling from the CIS. The original randomization plan called for approximately half of the total sample of 1034 participants to be randomized to this intervention group (No CIS) and the other half to the CIS intervention group. However, due to a problem in the electronic transfer of data from the research coordinating site to CIS, 581 participants were randomized to "No CIS" group and 453 to the CIS group.
|
Nicotine Replacement Therapy (NRT; Mini-Lozenge for 2 Weeks)
n=518 Participants
Participants in this intervention group received a 2-week starter package of nicotine mini-lozenges, with dose based on time to since first cigarette of the day as per package instructions. Each package contained 2 mini-lozenge dispensers (162 lozenges total) and instructions on proper use. Approximately half of the total sample of 1034 participants was randomized to receive the 2-week supply of mini-lozenges; the other half received no mini-lozenges.
|
No Nicotine Replacement Therapy
n=516 Participants
Participants in this intervention group received no nicotine replacement therapy (NRT), i.e., no nicotine mini-lozenges. Approximately half of the total sample of 1034 participants was randomized to receive no NRT; the other half a 2-week supply of nicotine mini-lozenges.
|
Email Messaging
n=526 Participants
Participants Email Messaging intervention group received brief email messages that could be accessed by any computer or mobile device that allowed email receipt. Messages were intended to provide: (1) Motivation/encouragement; (2) Quitting tips and information; (3) Adherence/education prompts (to use available resources as recommended), and (4) relapse prevention content. These emailed messages were sent twice/day for two weeks, once/day for an additional month, and then one every 3rd day for an additional 6 weeks (constituting a 3-month-long intervention). Approximately half of the total sample of 1034 participants was randomized to receive Email Messaging; the other half received no Email Messaging.
|
No Email Messaging
n=508 Participants
Participants in this intervention group received no Email Messaging. Approximately half of the total sample of 1034 participants was randomized to receive no Email Messaging; the other half received 3 months of Email Messaging.
|
Full SmokeFree.Gov Website
n=525 Participants
Participants in the Full SmokeFree.gov website intervention group received the standard smokefree.gov website content that included resources to motivate quitting and a step-by-step quitting guide that provided a skill-based intervention for preparing to quit, quitting, and maintaining abstinence. In addition, the active website offered encouragement and support, motivational information, and interactive features and referral links. The active website did not include direct interaction with users (e.g. live help) or interactive audio or video content. User-engagement features included task charts for behavior change, self-monitoring tools (e.g. for cravings and self-assessment), creation of a personal calendar, links to a quitline or to a counselor via text message for live help and social support through social media. No tailoring, feedback or outbound reminders were in use. Approximately half of the total sample of 1034 participants was randomized to receive the Full Smoke
|
Lite SmokeFree.Gov Website
n=509 Participants
Participants in the Lite SmokeFree.gov Website intervention group received received the "Lite" version of the website (developed by the investigators for this research) that included information about smoking and health such as benefits of quitting and information about withdrawal, medications and stress, but contained no interactive features or content that would support skill training. The look and graphics directly mirrored the full smokefree.gov website, but the number of web pages was reduced from over 50 to 16, and external links to resources were virtually eliminated. Approximately half of the total sample of 1034 participants was randomized to receive theLite SmokeFree.gov Website; the other half received the Full SmokeFree.gov Website.
|
Full Cessation Booklet
n=517 Participants
Participants in the Full Cessation Booklet intervention group received the National Cancer Institute's 36-page "Clearing the Air" brochure (www.smokefree.gov/pubs/clearing\_the\_air.pdf), containing a detailed guide for preparing to quit, quitting, and preventing relapse as well as suggested resources. Approximately half of the total sample of 1034 participants was randomized to receive the Full Cessation Booklet; the other half received a Brief Cessation Booklet.
|
Brief Cessation Booklet
n=517 Participants
Participants in the Full Cessation Booklet intervention group received a 12-page booklet developed by the investigators. The content of this booklet was the same as contained in the 36-page "Clearing the Air" booklet except that information directly relevant to coping skill training (identification of smoking triggers, making coping plans) was removed. Approximately half of the total sample of 1034 participants was randomized to receive the Brief Cessation Booklet; the other half received the Full Cessation Booklet.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
7-Day Point-Prevalence Abstinence From Smoking
|
27.8 percentage of participants not smoking
|
26.3 percentage of participants not smoking
|
30.5 percentage of participants not smoking
|
23.4 percentage of participants not smoking
|
26.2 percentage of participants not smoking
|
27.8 percentage of participants not smoking
|
29.5 percentage of participants not smoking
|
24.4 percentage of participants not smoking
|
26.3 percentage of participants not smoking
|
27.7 percentage of participants not smoking
|
SECONDARY outcome
Timeframe: Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.Inclusive of smoking rate amongst those smoking, smoking cessation milestones: initial cessation, lapse latency, lapse-relapse latency; and setting a quit date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at the 7 month follow up assessment. Furthermore, Website use will be collected as pages viewed, time viewed, use occasions, and composite measures. Counseling use will be measured by number of counseling calls.We will measure participants' use the experimental resources compared to the non-experimental resources. Particularly with the study websites, we will be tracking how often and how long participants use the regular smokefree.gov website versus the placebo website as well as what parts of the websites they are using for 6 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Data collected at all assessments (Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow ups), during web use measurements (6 months), and counseling calls measurements (4 weeks). Analyzed after the study.We will measure how these experimental resources (as well as combinations of resources) aid in quit attempts and abstinence outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.We will measure the manifestation and severity of withdrawal symptoms of participants in each treatment group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at the1 month, 3 month and 7 month follow up assessments.We will measure perceived support from both treatment and non-treatment resources.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at the 1 month, 3 month and 7 month follow up assessmentsWe will measure how satisfied participants were with the resources they were given as well as what might have made their quit attempts easier or more successful.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at the 1 month, 3 month and 7 month follow up assessments.Quit attempts will be defined in two ways: self-report of a serious attempt to quit, and occurrence of at least a 24 hr period of abstinence that was for the purpose of cessation.
Outcome measures
Outcome data not reported
Adverse Events
Lozenge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place