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

Phase 3

Completed

Conditions: Smoking Cessation

Interventions: Behavioral: Telephone Counseling
Drug: Nicotine Patches

Registration Number: NCT01287377

Lead Sponsor: University of California, San Diego

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 243

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pre-Patch and Telephone Counseling	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.
Pre-Patch and Telephone Counseling	Nicotine Patches	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.
Post-Patch and Telephone Counseling	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.
Telephone Counseling and no patches sent	Telephone Counseling	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.
Post-Patch and Telephone Counseling	Nicotine Patches	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Have Not Used Tobacco in the Past 30 Days	2-months post enrollment	At a given point in time (in this case, 2 months after program registration), quitline participants are asked whether they have used cigarettes or other forms of tobacco in the past 30 days. Those who reply that they have not used tobacco in the past 30 days are considered to have quit.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Serious Quit Attempts	2-months post enrollment	A serious quit attempt is considered is a quit attempt that last more than 24 hours