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

University of California San Diego

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

Treatments: Behavioral: Telephone Counseling; Drug: Nicotine Patches

Study type: Interventional

Funder types: Other

Identifiers

NCT01287377

100683

Details and patient eligibility

About

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.

Full 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.

Enrollment: 243 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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243 participants in 3 patient groups

Pre-Patch and Telephone Counseling

Experimental group

Description:

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.

Treatment:

Behavioral: Telephone Counseling

Drug: Nicotine Patches

Post-Patch and Telephone Counseling

Active Comparator group

Description:

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.

Treatment:

Behavioral: Telephone Counseling

Drug: Nicotine Patches

Telephone Counseling and no patches sent

Active Comparator group

Description:

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.

Treatment:

Behavioral: Telephone Counseling