A Randomized Trial of Internet Access to Nicotine Patches

The objective of this project is to determine the efficacy and cost-effectiveness of
providing access to free nicotine patches, with or without a required linkage to proactive
telephone counseling, as adjuncts to internet-assisted tobacco treatment. Online cessation
services will be provided by the Center for Health Communication Research at the University
of Michigan.

This investigation has three specific aims and one exploratory aim:

- Specific Aim 1: To determine the efficacy of providing access to free nicotine patches
as an addition to online smoking cessation services.

- Specific Aim 2: To determine the efficacy of providing access to free nicotine patches
linked with proactive telephone counseling as an addition to online smoking cessation
services.

- Specific Aim 3: To determine the cost-effectiveness of providing access to free
nicotine patches, with or without linkage to proactive phone counseling, as additions
to online cessation services.

- Exploratory Aim 1: To examine potential mediators and moderators of intervention
effects. An examination of potential mediators will identify key psychological and
behavioral processes (e.g. medication adherence, self-efficacy, etc.) that underlie how
the interventions affect the process of quitting and offer guidance regarding key
targets for future research. An examination of potential moderators (e.g. level of
dependence, income, gender) will identify candidate subgroups for which the proposed
interventions may be more effective and cost- effective.

Smokers searching online for help quitting (N=2,475) will be recruited and randomized to
receive one of three treatments:

1. online smoking cessation services (i.e. web),

2. online cessation services plus access to free nicotine patches (i.e.web+patch),

3. online cessation services with access to free patches contingent upon participation in
proactive telephone counseling (i.e. web+patch+phone).

The Center for Health Communications Research at the University of Michigan will serve as
the smoking cessation website for this research project. Developed by Vic Strecher and
colleagues, Project Quit is a web-based program designed to help individuals who would like
to quit smoking in the next 30 days. The program is grounded in cognitive-behavioral methods
of smoking cessation and relapse prevention. The web-based smoking cessation intervention
features highly tailored email messages. Once enrolled in the project and the baseline
assessment is completed, participants receive six tailored web sessions namely:

- Action plan (1 week before quit date);

- Barriers 1 (2 days before quit date);

- Supportive message (on quit date);

- Barriers 2 (2 days after quit date);

- Motivation (1 week after quit date);

- Testimonial (2 weeks after quit date).

Evaluations will occur at baseline and at 1-, 3-, and 9-months post-enrollment. The primary
outcome measure will be self-reported 6-month prolonged abstinence measured at the 9-month
evaluation.

This proposal addresses a critical need for evidence-based cessation treatments for smokers.
At the completion of this project, it is our expectation that we will have identified an
effective online intervention package (or packages) for dissemination of internet-assisted
tobacco treatment.

This study will enroll people recruited via online sources. Participants will complete a
baseline survey about their smoking habits and quit history. Participants will then be
randomly assigned to one of the following three treatment groups:

- Group 1 participants will receive access to an online tailored stop smoking program.

- Group 2 participants will receive free access to nicotine patches and an online
tailored stop smoking program.

- Group 3 participants will receive telephone counseling, free access to nicotine patches
and an online tailored stop smoking program.

Participants receiving telephone counseling will receive 5 phone calls over a 2-month period
to discuss their personal smoking cessation plan; they must complete the pre-quit and 7-10
day calls in order to receive the nicotine patches. At 1, 3, and 9 months post-enrollment,
all participants will complete online surveys about their smoking cessation experience.
Participants will be contacted by phone to complete the surveys if they do not complete them
online.

Inclusion Criteria:

- Currently smokes 10 or more cigarettes per day

- Does not use any tobacco products other than cigarettes

- Willing to set a quit date within 2 to 4 weeks following study entry

- Willing to use a nicotine patch

- Able to speak English

- Access to Internet, email, and telephone at work or home

- Resident of the United States

- Only one person per household is eligible to enroll

Exclusion Criteria:

- Medically unable to use the nicotine patch (e.g., pregnant, history of a heart
attack)

- Currently uses nicotine replacement therapy (NRT) products

- Currently uses or plans to use Bupropion SR, Wellbutrin, or Zyban