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)
• Enrollment: 4,200
• Location: 1
• Arms: 6
• Duration (Months): 33.9
• Patients Per Site Per Month: 123.8

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 Disease	Intervention/Treatment	Phase
Smoking Cessation	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

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: 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

	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.

• 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: Nicotine Replacement Therapy; Nicotine Patch; Smoking cessation; Telephone; Tobacco cessation; Counseling; Nicotine; Self-Help; Smoking abstinence; Tobacco Use Disorder
• Additional relevant MeSH terms: Nicotine

Study Results

Participant Flow

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

1. Primary Outcome

Title	Number of Participants With Six-month Continuous Abstinence From Cigarettes
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%

2. Secondary Outcome

Title	Number of Participants Quit for 30-days at 2-months Post Enrollment
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

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

[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.