Telephone Counseling and the Distribution of Nicotine Patches to Smokers

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT00851357
Collaborator
California Department of Health Services (Other)
4,200
Enrollment
1
Location
6
Arms
33.9
Duration (Months)
123.8
Patients Per Site Per Month

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:

  1. 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).

  2. Test if sending placebo patches directly will also lead to a higher quit rate.

  3. Test if quitline counseling increases the quit rate when the smokers already receive the nicotine patches.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Nicotine Patch
  • Behavioral: Telephone Counseling
  • Drug: Placebo
  • Other: Self-Help Materials
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

Study Type:
Interventional
Actual Enrollment :
4200 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Telephone Counseling and the Centralized Distribution of Nicotine Replacement Therapy Through a Smoking Cessation Quitline
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Oct 1, 2010
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

ArmIntervention/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:
  • Habitrol
  • 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:
  • Non-nicotine patch
  • 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:
  • Habitrol
  • 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:
  • Non-nicotine patch
  • 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

    1. Number of Participants With Six-month Continuous Abstinence From Cigarettes [7 months post enrollment]

    Secondary Outcome Measures

    1. Number of Participants Quit for 30-days at 2-months Post Enrollment [2-months post enrollment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    SiteCityStateCountryPostal Code
    1University of Californian, San Diego: California Smokers' HelplineSan DiegoCaliforniaUnited States92111

    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.
    Responsible Party:
    Shu-Hong Zhu, Professor, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT00851357
    Other Study ID Numbers:
    • CDPH 05-45834
    First Posted:
    Feb 25, 2009
    Last Update Posted:
    Feb 13, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Shu-Hong Zhu, Professor, University of California, San Diego
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleUsual CarePatch (Placebo)Patch (Real)
    Arm/Group DescriptionSubjects 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
    STARTED120012011799
    COMPLETED120012011799
    NOT COMPLETED000

    Baseline Characteristics

    Arm/Group TitleUsual CarePatch (Placebo)Patch (Real)Total
    Arm/Group DescriptionSubjects 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 Participants1200120117994200
    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

    1. Primary Outcome
    TitleNumber of Participants With Six-month Continuous Abstinence From Cigarettes
    Description
    Time Frame7 months post enrollment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleUsual CarePatch (Placebo)Patch (Real)
    Arm/Group DescriptionSubjects 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 Participants120012011799
    Count of Participants [Participants]
    70
    5.8%
    101
    8.4%
    190
    10.6%
    2. Secondary Outcome
    TitleNumber of Participants Quit for 30-days at 2-months Post Enrollment
    Description
    Time Frame2-months post enrollment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleUsual CarePatch (Placebo)Patch (Real)
    Arm/Group DescriptionSubjects 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 Participants120012011799
    Count of Participants [Participants]
    136
    11.3%
    173
    14.4%
    334
    18.6%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group TitleUsual CarePatch (Placebo)Patch (Real)
    Arm/Group DescriptionSubjects 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 CarePatch (Placebo)Patch (Real)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Usual CarePatch (Placebo)Patch (Real)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/1200 (0%) 0/1201 (0%) 0/1799 (0%)
    Other (Not Including Serious) Adverse Events
    Usual CarePatch (Placebo)Patch (Real)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/1200 (0%) 0/1201 (0%) 0/1799 (0%)

    Limitations/Caveats

    [Not Specified]

    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/TitlePrincipal Investigator
    OrganizationUCSD
    Phone858-300-1056
    Emailszhu@ucsd.edu
    Responsible Party:
    Shu-Hong Zhu, Professor, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT00851357
    Other Study ID Numbers:
    • CDPH 05-45834
    First Posted:
    Feb 25, 2009
    Last Update Posted:
    Feb 13, 2020
    Last Verified:
    Feb 1, 2020