Trial Outcomes & Findings for Optimizing Tobacco Dependence Treatment in the Emergency Department (NCT NCT02896400)
NCT ID: NCT02896400
Last Updated: 2020-12-04
Results Overview
Abstinence self reported and verified by exhaled carbon monoxide
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1056 participants
Primary outcome timeframe
3 months
Results posted on
2020-12-04
Participant Flow
Participant milestones
| Measure |
NRT+QL+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
BNI+QL+Text
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
BNI+NRT+QL+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
NRT+QL
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
|
BNI+QL
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
|
NRT Only
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
|
BNI+Text
Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
BNI+NRT+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
NRT+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
BNI+NRT
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
|
Control
Control arm, no intervention
|
BNI+NRT+QL
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
|
Text Only
Registration in SmokefreeText (Text)
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
QL+Text
Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
BNI Only
Brief Negotiated Interview (BNI)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
|
QL Only
Referral to CT Smokers Quitline (QL)
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Baseline
STARTED
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
|
Baseline
COMPLETED
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
1 Month Follow-up
STARTED
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
|
1 Month Follow-up
COMPLETED
|
59
|
59
|
61
|
58
|
57
|
60
|
61
|
60
|
62
|
59
|
61
|
61
|
63
|
62
|
65
|
63
|
|
1 Month Follow-up
NOT COMPLETED
|
7
|
7
|
5
|
8
|
9
|
6
|
5
|
6
|
4
|
7
|
5
|
5
|
3
|
4
|
1
|
3
|
|
3 Month Follow-up
STARTED
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
66
|
65
|
|
3 Month Follow-up
COMPLETED
|
60
|
63
|
60
|
55
|
54
|
60
|
62
|
63
|
60
|
61
|
60
|
60
|
63
|
60
|
62
|
63
|
|
3 Month Follow-up
NOT COMPLETED
|
6
|
3
|
6
|
11
|
12
|
6
|
4
|
3
|
6
|
5
|
6
|
6
|
3
|
6
|
4
|
2
|
|
Biochemical Verification at 3 Months
STARTED
|
60
|
63
|
60
|
55
|
54
|
60
|
62
|
63
|
60
|
61
|
60
|
60
|
63
|
60
|
62
|
63
|
|
Biochemical Verification at 3 Months
COMPLETED
|
14
|
15
|
13
|
14
|
9
|
11
|
11
|
14
|
15
|
8
|
5
|
19
|
10
|
12
|
7
|
6
|
|
Biochemical Verification at 3 Months
NOT COMPLETED
|
46
|
48
|
47
|
41
|
45
|
49
|
51
|
49
|
45
|
53
|
55
|
41
|
53
|
48
|
55
|
57
|
Reasons for withdrawal
| Measure |
NRT+QL+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
BNI+QL+Text
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
BNI+NRT+QL+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
NRT+QL
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
|
BNI+QL
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
|
NRT Only
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
|
BNI+Text
Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
BNI+NRT+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
NRT+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
BNI+NRT
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
|
Control
Control arm, no intervention
|
BNI+NRT+QL
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
|
Text Only
Registration in SmokefreeText (Text)
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
QL+Text
Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
BNI Only
Brief Negotiated Interview (BNI)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
|
QL Only
Referral to CT Smokers Quitline (QL)
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
1 Month Follow-up
Lost to Follow-up
|
7
|
7
|
5
|
8
|
9
|
6
|
5
|
6
|
4
|
7
|
5
|
5
|
3
|
4
|
1
|
2
|
|
1 Month Follow-up
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
3 Month Follow-up
Lost to Follow-up
|
6
|
3
|
6
|
11
|
12
|
6
|
4
|
3
|
6
|
5
|
6
|
6
|
3
|
5
|
3
|
2
|
|
3 Month Follow-up
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Biochemical Verification at 3 Months
Lost to Follow-up
|
1
|
0
|
1
|
1
|
0
|
1
|
3
|
2
|
1
|
1
|
0
|
0
|
1
|
0
|
3
|
1
|
|
Biochemical Verification at 3 Months
participant was not eligible for biochem
|
45
|
48
|
46
|
40
|
45
|
48
|
48
|
47
|
44
|
52
|
55
|
41
|
52
|
48
|
52
|
56
|
Baseline Characteristics
Optimizing Tobacco Dependence Treatment in the Emergency Department
Baseline characteristics by cohort
| Measure |
NRT+QL+Text
n=66 Participants
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
BNI+QL+Text
n=66 Participants
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
BNI+NRT+QL+Text
n=66 Participants
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
NRT+QL
n=66 Participants
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
|
BNI+QL
n=66 Participants
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
|
NRT Only
n=66 Participants
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
|
BNI+Text
n=66 Participants
Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
BNI+NRT+Text
n=66 Participants
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
NRT+Text
n=66 Participants
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
BNI+NRT
n=66 Participants
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
|
Control
n=66 Participants
Control arm, no intervention
|
BNI+NRT+QL
n=66 Participants
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
Nicotine replacement therapy (NRT): 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
|
Text Only
n=66 Participants
Registration in SmokefreeText (Text)
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
QL+Text
n=66 Participants
Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
SmokefreeText (Text): Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
|
BNI Only
n=66 Participants
Brief Negotiated Interview (BNI)
Brief Negotiated Interview (BNI): Brief motivational interview on smoking behavior
|
QL Only
n=66 Participants
Referral to CT Smokers Quitline (QL)
CT Smokers Quitline (QL): Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
|
Total
n=1056 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.86 years
STANDARD_DEVIATION 10.72 • n=5 Participants
|
41.33 years
STANDARD_DEVIATION 11.92 • n=7 Participants
|
44.36 years
STANDARD_DEVIATION 12.75 • n=5 Participants
|
43.73 years
STANDARD_DEVIATION 12.14 • n=4 Participants
|
40.56 years
STANDARD_DEVIATION 11.97 • n=21 Participants
|
42.26 years
STANDARD_DEVIATION 12.27 • n=8 Participants
|
42.64 years
STANDARD_DEVIATION 12.42 • n=8 Participants
|
43.77 years
STANDARD_DEVIATION 11.80 • n=24 Participants
|
43.67 years
STANDARD_DEVIATION 12.60 • n=42 Participants
|
44.30 years
STANDARD_DEVIATION 13.23 • n=42 Participants
|
43.65 years
STANDARD_DEVIATION 14.00 • n=42 Participants
|
43.18 years
STANDARD_DEVIATION 10.67 • n=42 Participants
|
44.33 years
STANDARD_DEVIATION 12.23 • n=36 Participants
|
42.36 years
STANDARD_DEVIATION 12.49 • n=36 Participants
|
41.86 years
STANDARD_DEVIATION 10.42 • n=24 Participants
|
43.21 years
STANDARD_DEVIATION 11.77 • n=135 Participants
|
43.26 years
STANDARD_DEVIATION 12.12 • n=136 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
41 Participants
n=42 Participants
|
35 Participants
n=42 Participants
|
35 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
33 Participants
n=36 Participants
|
42 Participants
n=36 Participants
|
31 Participants
n=24 Participants
|
36 Participants
n=135 Participants
|
536 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
38 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
37 Participants
n=42 Participants
|
33 Participants
n=36 Participants
|
24 Participants
n=36 Participants
|
35 Participants
n=24 Participants
|
30 Participants
n=135 Participants
|
520 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
13 Participants
n=36 Participants
|
19 Participants
n=36 Participants
|
14 Participants
n=24 Participants
|
10 Participants
n=135 Participants
|
231 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
55 Participants
n=8 Participants
|
45 Participants
n=8 Participants
|
55 Participants
n=24 Participants
|
51 Participants
n=42 Participants
|
43 Participants
n=42 Participants
|
52 Participants
n=42 Participants
|
49 Participants
n=42 Participants
|
51 Participants
n=36 Participants
|
45 Participants
n=36 Participants
|
52 Participants
n=24 Participants
|
56 Participants
n=135 Participants
|
807 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
18 Participants
n=136 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
15 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
9 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
26 Participants
n=42 Participants
|
29 Participants
n=36 Participants
|
28 Participants
n=36 Participants
|
19 Participants
n=24 Participants
|
29 Participants
n=135 Participants
|
401 Participants
n=136 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
35 Participants
n=24 Participants
|
37 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
35 Participants
n=42 Participants
|
30 Participants
n=36 Participants
|
28 Participants
n=36 Participants
|
34 Participants
n=24 Participants
|
31 Participants
n=135 Participants
|
537 Participants
n=136 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
63 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
28 Participants
n=136 Participants
|
|
Region of Enrollment
United States
|
66 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
66 Participants
n=8 Participants
|
66 Participants
n=8 Participants
|
66 Participants
n=24 Participants
|
66 Participants
n=42 Participants
|
66 Participants
n=42 Participants
|
66 Participants
n=42 Participants
|
66 Participants
n=42 Participants
|
66 Participants
n=36 Participants
|
66 Participants
n=36 Participants
|
66 Participants
n=24 Participants
|
66 Participants
n=135 Participants
|
1056 Participants
n=136 Participants
|
|
Cigarettes per Day (CPD)
|
10.0 cigarettes per day
n=5 Participants
|
12.0 cigarettes per day
n=7 Participants
|
10.0 cigarettes per day
n=5 Participants
|
10.0 cigarettes per day
n=4 Participants
|
10.0 cigarettes per day
n=21 Participants
|
10.0 cigarettes per day
n=8 Participants
|
10.0 cigarettes per day
n=8 Participants
|
10.0 cigarettes per day
n=24 Participants
|
9.0 cigarettes per day
n=42 Participants
|
10.0 cigarettes per day
n=42 Participants
|
10.0 cigarettes per day
n=42 Participants
|
11.0 cigarettes per day
n=42 Participants
|
10.0 cigarettes per day
n=36 Participants
|
10.0 cigarettes per day
n=36 Participants
|
10.0 cigarettes per day
n=24 Participants
|
10.0 cigarettes per day
n=135 Participants
|
10.0 cigarettes per day
n=136 Participants
|
|
Heaviness of Smoking Index >=4
|
15 participants
n=5 Participants
|
28 participants
n=7 Participants
|
13 participants
n=5 Participants
|
18 participants
n=4 Participants
|
9 participants
n=21 Participants
|
23 participants
n=8 Participants
|
20 participants
n=8 Participants
|
13 participants
n=24 Participants
|
13 participants
n=42 Participants
|
21 participants
n=42 Participants
|
15 participants
n=42 Participants
|
21 participants
n=42 Participants
|
19 participants
n=36 Participants
|
13 participants
n=36 Participants
|
17 participants
n=24 Participants
|
12 participants
n=135 Participants
|
270 participants
n=136 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All participants eligible for 3 month follow-up (deceased participants excluded). Each intervention group was compared with all participants who did not receive that intervention. The comparison group therefore differed for each intervention: BNI=526; NRT=525; QL=527; Text = 526.
Abstinence self reported and verified by exhaled carbon monoxide
Outcome measures
| Measure |
Brief Negotiated Interview (BNI)
n=527 Participants
All 8 arms with Brief Negotiated Interview as an intervention:
BNI only BNI+Nicotine Replacement Therapy (NRT) BNI+Quitline (QL) BNI+Text BNI+NRT+QL BNI+NRT+Text BNI+QL+Text BNI+NRT+QL+Text
|
Brief Negotiated Interview (BNI) CONTROL
n=526 Participants
All 8 arms which did not include the BNI intervention:
NRT+QL+Text NRT+QL NRT+Text NRT QL+Text QL Text Control
|
Nicotine Replacement Therapy (NRT)
n=528 Participants
All 8 arms with Nicotine Replacement Therapy as an intervention:
NRT only Brief Negotiated Interview (BNI)+NRT NRT+Quitline (QL) NRT+Text BNI+NRT+QL BNI+NRT+Text NRT+QL+Text BNI+NRT+QL+Text
|
Nicotine Replacement Therapy (NRT) CONTROL
n=525 Participants
All 8 arms which did not include the NRT intervention:
BNI+QL+Text BNI+QL BNI+Text BNI Only QL+Text QL Only Text Only Control
|
Quitline (QL)
n=526 Participants
All 8 arms with the Quitline as an intervention:
QL only Brief Negotiated Interview (BNI)+QL Nicotine Replacement Therapy (NRT)+QL QL+Text BNI+NRT+QL BNI+QL+Text NRT+QL+Text BNI+NRT+QL+Text
|
Quitline (QL) CONTROL
n=527 Participants
All 8 arms which did not include the QL intervention:
BNI+NRT+Text BNI+NRT BNI+Text BNI Only NRT+Text NRT Only Text Only Control
|
Text
n=527 Participants
All 8 arms with Text as an intervention:
Text only Brief Negotiated Interview (BNI)+Text Nicotine Replacement Therapy (NRT)+Text Quitline (QL)+Text BNI+NRT+Text BNI+QL+Text NRT+QL+Text BNI+NRT+QL+Text
|
Text CONTROL
n=526 Participants
All 8 arms which did not include the Text intervention:
BNI+NRT+QL BNI+NRT BNI+QL BNI Only NRT+QL NRT Only QL Only Control
|
|---|---|---|---|---|---|---|---|---|
|
Tobacco Abstinence
|
71 Participants
|
49 Participants
|
76 Participants
|
44 Participants
|
66 Participants
|
54 Participants
|
61 Participants
|
59 Participants
|
Adverse Events
NRT+QL+Text
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BNI+QL+Text
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BNI+NRT+QL+Text
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NRT+QL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BNI+QL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NRT Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BNI+Text
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BNI+NRT+Text
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NRT+Text
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BNI+NRT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BNI+NRT+QL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Text Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
QL+Text
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
BNI Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
QL Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 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