Clinical trial NCT01287377: Smoking Cessation With the Nicotine Patch: A Pilot Study of Patch Messaging
Official title: Smoking Cessation With the Nicotine Patch: A Pilot Study of Patch Messaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: tobacco cessation
smoking cessation
nicotine
counseling
telephone
self-help
smoking abstinence
tobacco use disorder
nicotine replacement therapy
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2011-02-01
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants Who Have Not Used Tobacco in the Past 30 Days
timeFrame: 2-months post enrollment
Secondary outcomes:
measure: Number of Participants With Serious Quit Attempts
timeFrame: 2-months post enrollment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: UCSD
name: Shu-Hong Zhu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: