Smoking Cessation With the Nicotine Patch: A Pilot Study of Patch Messaging

NCT ID: NCT01287377

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-11-30

Brief Summary

The primary purpose of this study is to test the feasibility of sending pre-cessation nicotine patches and to examine the effects associated with the pre-cessation treatment phase. Specifically, this study aims to:

1. See if subjects will use pre-cessation nicotine patches.

2. See if subjects in the pre-cessation nicotine patches go on to get more nicotine patches.

3. See if pre-cessation treatment with nicotine patches leads to a decrease in number of cigarettes smoked per day.

4. See if sending 2-weeks' worth of patches is helpful to the quitting process.

Detailed Description

Quitlines have become central to state tobacco control efforts in the U.S. In addition to offering telephone counseling, many quitlines have begun providing quitting aids (e.g., nicotine patch) to eligible smokers. The nicotine patch has been shown repeatedly to double the rate of quitting success compared to a placebo control. Recently a number of studies have examined the use of patches prior to quitting. A meta-analysis indicates that such pre-cessation treatment with nicotine patches doubles the odds of quitting, compared to starting patch treatment on the quit day, as is traditionally done.

The proposed study would look at both pre-cessation treatment with nicotine patches as well as looking to see if sending clients nicotine patches is helpful in their quitting process. The rationale for pre-cessation treatment with patches is that using patches in this manner would make it easier to quit smoking because it may: reduce the reinforcing effects of cigarette smoking, thus helping to overcome conditioned behavior; reduce the need for inhaled nicotine as smokers naturally decrease their cigarette consumption to titrate the level of nicotine in their system; and/or increase compliance with patch use in the quitting phase.

The rationale for sending nicotine patches is that when callers must go and get the patches on their own it creates a barrier to their quitting so that sending nicotine patches directly to a callers' home would make it easier for them to stay on task and quit. This pilot will allow us to test the feasibility of sending pre-treatment nicotine patches and to examine the effects associated with the pre-cessation treatment phase.

This pilot project has the following specific aims, to examine whether:

1. Subjects will use pre-cessation nicotine patches.

2. Subjects in the pre-cessation nicotine patches go on to get more nicotine patches.

3. Pre-cessation treatment with nicotine patches leads to a decrease in number of cigarettes smoked per day.

4. Sending 2-weeks' worth of patches is helpful to the quitting process.

Results will add to the theoretical understanding of behavior change from which new, effective interventions can spring.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-Patch and Telephone Counseling

Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients will be encouraged to start using these patches PRIOR to their quit date.

Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.

Group Type: EXPERIMENTAL

Telephone Counseling

Intervention Type: BEHAVIORAL

Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.

Nicotine Patches

Intervention Type: DRUG

Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to start using it right away, or usual care patches in which no patches are sent directly (although clients may still get them through their usual channels).

For those in the usual care condition, patches will not be mailed directly to them; however, we will facilitate their use by providing a certificate that can be used by the State Medicaid program and some other insurance companies to obtain free patches. For those in the active condition, we will mail 2 weeks of patches directly to their home. All subjects will receive a 2 week starter kit with fourteen 21mg patches.

Post-Patch and Telephone Counseling

Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients are encouraged to start using their patches ON their quit date.

Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.

Group Type: ACTIVE_COMPARATOR

Telephone Counseling

Intervention Type: BEHAVIORAL

Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.

Nicotine Patches

Intervention Type: DRUG

Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to start using it right away, or usual care patches in which no patches are sent directly (although clients may still get them through their usual channels).

For those in the usual care condition, patches will not be mailed directly to them; however, we will facilitate their use by providing a certificate that can be used by the State Medicaid program and some other insurance companies to obtain free patches. For those in the active condition, we will mail 2 weeks of patches directly to their home. All subjects will receive a 2 week starter kit with fourteen 21mg patches.

Telephone Counseling and no patches sent

Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.

Group Type: ACTIVE_COMPARATOR

Telephone Counseling

Intervention Type: BEHAVIORAL

Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.

Interventions

Telephone Counseling

Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.

Intervention Type: BEHAVIORAL

Nicotine Patches

Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to start using it right away, or usual care patches in which no patches are sent directly (although clients may still get them through their usual channels).

For those in the usual care condition, patches will not be mailed directly to them; however, we will facilitate their use by providing a certificate that can be used by the State Medicaid program and some other insurance companies to obtain free patches. For those in the active condition, we will mail 2 weeks of patches directly to their home. All subjects will receive a 2 week starter kit with fourteen 21mg patches.

Intervention Type: DRUG

Other Intervention Names

Habitrol

Eligibility Criteria

Inclusion Criteria

• >= 18 years old
• Daily smoker
• >=10 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 speaking

Exclusion Criteria

• Uses other form of tobacco
• Plan to use quitting aids other than nicotine patch
• Has any of the following conditions:
• Severe allergy to adhesive tape
• Arrhythmia
• Angina
• Heart attack within last 6 months
• Stroke within last 6 months
• Uncontrolled high blood pressure
• Insulin-dependent diabetes
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Shu-Hong Zhu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shu-Hong Zhu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

University of California San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

100683

Identifier Type: -

Identifier Source: org_study_id