Telephone Counseling and the Distribution of Nicotine Patches to Smokers
Study Details
Study Description
Brief Summary
The primary purpose of this study is to determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims to:
-
Test if sending active nicotine patches directly will lead to a higher quit rate, compared to a condition where the quitline assists the smokers to obtain patches by other means (e.g. via their health plans).
-
Test if sending placebo patches directly will also lead to a higher quit rate.
-
Test if quitline counseling increases the quit rate when the smokers already receive the nicotine patches.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
Studies have shown that statewide tobacco quitlines can dramatically increase call volume by offering direct mailings of free nicotine replacement therapy (NRT) products. Sending free NRT such as patches to quitline callers, however, often requires a large budget because quitlines have a large number of smokers calling for help each year. A strong rationale is needed for state funding agencies to pay for the patches, which are generally considered the responsibility of health plans. This study will contrast the condition of sending nicotine patches directly from the quitline with a condition where the quitline assists smokers to obtain patches by other means, primarily through their health plans. The study aims to demonstrate that sending patches immediately after smokers call the quitline has a motivational effect that will lead to a higher quit rate than if smokers have to obtain the patches themselves, even if they are able to obtain them for free. To tease apart how much of the effect of sending patches directly from the quitline is due to the active ingredient in the patches and how much is due to motivational effects, this study adds a placebo condition. We hypothesize that the active patches condition will outperform the placebo condition, and the sending of placebo patches will outperform the condition in which the smokers obtain the nicotine patches themselves. We also hypothesize that counseling has its own effect on quitting above and beyond that of the nicotine patches. This study will supply data that can be used to decide what role nicotine replacement therapy should play in publicly funded tobacco cessation programs. Results will also add to the theoretical understanding of behavior change from which new, effective interventions can spring.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Active patches and telephone counseling Proactive Telephone Counseling and 8-weeks of nicotine patches |
Drug: Nicotine Patch
Subjects are randomized into 1 of 3 conditions: active, placebo or usual care. Usual care subjects are not mailed patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches. For those mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
Other Names:
Behavioral: Telephone Counseling
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.
Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and discussion of nicotine patch use) plus up to 5 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling.
|
Placebo Comparator: Placebo patches and telephone counseling Proactive Telephone Counseling and 8-weeks of placebo patches |
Behavioral: Telephone Counseling
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.
Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and discussion of nicotine patch use) plus up to 5 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling.
Drug: Placebo
Placebo nicotine patch
Other Names:
|
Active Comparator: Telephone counseling Proactive Telephone Counseling |
Behavioral: Telephone Counseling
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.
Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and discussion of nicotine patch use) plus up to 5 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling.
|
Active Comparator: Active patches and materials 8-weeks of nicotine patches and materials |
Drug: Nicotine Patch
Subjects are randomized into 1 of 3 conditions: active, placebo or usual care. Usual care subjects are not mailed patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches. For those mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
Other Names:
Other: Self-Help Materials
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.
Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Reading materials and written consent will be mailed to all study subjects the next business day.
|
Active Comparator: Placebo patches and materials 8-weeks placebo patches and materials |
Drug: Placebo
Placebo nicotine patch
Other Names:
Other: Self-Help Materials
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.
Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Reading materials and written consent will be mailed to all study subjects the next business day.
|
Active Comparator: Materials Self-help materials |
Other: Self-Help Materials
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.
Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Reading materials and written consent will be mailed to all study subjects the next business day.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Six-month Continuous Abstinence From Cigarettes [7 months post enrollment]
Secondary Outcome Measures
- Number of Participants Quit for 30-days at 2-months Post Enrollment [2-months post enrollment]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
= 18 years old
-
Daily smoker
-
=6 cigarettes per day
-
Ready to quit within one month
-
First time quitline caller
-
Valid phone number
-
Valid address (no P.O. boxes)
-
California resident
-
Agree to participate in study and evaluation
-
English or Spanish speaking
Exclusion Criteria:
-
Uses other form of tobacco
-
Use of Zyban or Chantix
-
One of the following conditions: Severe allergy to adhesive tape, Arrhythmia, Angina, Heart attack within last year, Stroke within last year, Uncontrolled high blood pressure, Insulin-dependent diabetes, Pregnancy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Californian, San Diego: California Smokers' Helpline | San Diego | California | United States | 92111 |
Sponsors and Collaborators
- University of California, San Diego
- California Department of Health Services
Investigators
- Principal Investigator: Shu-Hong Zhu, Ph.D., University of California, San Diego
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDPH 05-45834
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Usual Care | Patch (Placebo) | Patch (Real) |
---|---|---|---|
Arm/Group Description | Subjects are not mailed nicotine patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches. | Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches. | Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. |
Period Title: Overall Study | |||
STARTED | 1200 | 1201 | 1799 |
COMPLETED | 1200 | 1201 | 1799 |
NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Usual Care | Patch (Placebo) | Patch (Real) | Total |
---|---|---|---|---|
Arm/Group Description | Subjects are not mailed nicotine patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches. | Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches. | Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. | Total of all reporting groups |
Overall Participants | 1200 | 1201 | 1799 | 4200 |
Age, Customized (Count of Participants) | ||||
18-24 |
136
11.3%
|
145
12.1%
|
205
11.4%
|
486
11.6%
|
25-44 |
569
47.4%
|
534
44.5%
|
877
48.7%
|
1980
47.1%
|
45-64 |
453
37.8%
|
461
38.4%
|
648
36%
|
1562
37.2%
|
65+ |
40
3.3%
|
61
5.1%
|
68
3.8%
|
169
4%
|
Unknown |
2
0.2%
|
0
0%
|
1
0.1%
|
3
0.1%
|
Sex: Female, Male (Count of Participants) | ||||
Female |
658
54.8%
|
645
53.7%
|
998
55.5%
|
2301
54.8%
|
Male |
542
45.2%
|
556
46.3%
|
801
44.5%
|
1899
45.2%
|
Race/Ethnicity, Customized (Count of Participants) | ||||
White |
638
53.2%
|
609
50.7%
|
888
49.4%
|
2135
50.8%
|
Black |
191
15.9%
|
194
16.2%
|
307
17.1%
|
692
16.5%
|
Hispanic |
250
20.8%
|
270
22.5%
|
421
23.4%
|
941
22.4%
|
Asian |
24
2%
|
36
3%
|
46
2.6%
|
106
2.5%
|
American Indian |
18
1.5%
|
16
1.3%
|
24
1.3%
|
58
1.4%
|
Multi-Race |
76
6.3%
|
73
6.1%
|
103
5.7%
|
252
6%
|
Unknown |
3
0.3%
|
3
0.2%
|
10
0.6%
|
16
0.4%
|
Education (Count of Participants) | ||||
<12 |
314
26.2%
|
288
24%
|
444
24.7%
|
1046
24.9%
|
HS Diploma |
405
33.8%
|
378
31.5%
|
595
33.1%
|
1378
32.8%
|
Some College |
396
33%
|
442
36.8%
|
631
35.1%
|
1469
35%
|
BA/BS or Higher |
84
7%
|
92
7.7%
|
128
7.1%
|
304
7.2%
|
Unknown |
1
0.1%
|
1
0.1%
|
1
0.1%
|
3
0.1%
|
Language (Count of Participants) | ||||
English |
1068
89%
|
1049
87.3%
|
1559
86.7%
|
3676
87.5%
|
Spanish |
132
11%
|
152
12.7%
|
240
13.3%
|
524
12.5%
|
Smoke Level (Count of Participants) | ||||
6-10 |
352
29.3%
|
353
29.4%
|
527
29.3%
|
1232
29.3%
|
11+ |
848
70.7%
|
848
70.6%
|
1272
70.7%
|
2968
70.7%
|
Outcome Measures
Title | Number of Participants With Six-month Continuous Abstinence From Cigarettes |
---|---|
Description | |
Time Frame | 7 months post enrollment |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Usual Care | Patch (Placebo) | Patch (Real) |
---|---|---|---|
Arm/Group Description | Subjects are not mailed nicotine patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches. | Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches. | Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. |
Measure Participants | 1200 | 1201 | 1799 |
Count of Participants [Participants] |
70
5.8%
|
101
8.4%
|
190
10.6%
|
Title | Number of Participants Quit for 30-days at 2-months Post Enrollment |
---|---|
Description | |
Time Frame | 2-months post enrollment |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Usual Care | Patch (Placebo) | Patch (Real) |
---|---|---|---|
Arm/Group Description | Subjects are not mailed nicotine patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches. | Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches. | Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. |
Measure Participants | 1200 | 1201 | 1799 |
Count of Participants [Participants] |
136
11.3%
|
173
14.4%
|
334
18.6%
|
Adverse Events
Time Frame | ||||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Usual Care | Patch (Placebo) | Patch (Real) | |||
Arm/Group Description | Subjects are not mailed nicotine patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches. | Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches. | Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. | |||
All Cause Mortality |
||||||
Usual Care | Patch (Placebo) | Patch (Real) | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
Usual Care | Patch (Placebo) | Patch (Real) | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/1200 (0%) | 0/1201 (0%) | 0/1799 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Usual Care | Patch (Placebo) | Patch (Real) | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/1200 (0%) | 0/1201 (0%) | 0/1799 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Principal Investigator |
---|---|
Organization | UCSD |
Phone | 858-300-1056 |
szhu@ucsd.edu |
- CDPH 05-45834