Trial Information

A Test of Two Clinical Methods to Prompt a Quit Attempt Among Smokers

Objectives

Among smokers who wish to quit at some time but do not plan to quit in the next month:

Major Hypotheses

Major Hypothesis 1: A treatment to reduce cigs/day that does not include nicotine
replacement therapy (NRT) will increase the incidence of a quit attempt (yes/no outcome).

Major Hypothesis 2: A motivational treatment based on the USPHS's 5 Rs will increase the
incidence of a quit attempt (yes/no outcome)

The current application focuses on new clinical interventions to increase quit attempts.
One recent method to increase quit attempts in ambivalent smokers has been reduction of
cigs/day. This method typically includes teaching ways to reduce cigs/day with the aid of
nicotine replacement therapy (NRT). Recent reviews and meta-analyses have concluded
reduction aided by NRT among ambivalent smokers consistently increases the probability of
future quit attempts and abstinence.

Another recent clinical method to prompt quit attempts is motivational treatments. The USPHS
treatment guidelines recommend smokers not ready to quit receive a briefer, somewhat
different motivational treatment focusing on the "5 Rs;" i.e., a) personal relevance of
smoking, b) risks of smoking, d) rewards from smoking cessation, d) roadblocks to quitting
and e) repetition.

Rationale for Proposed Studies: We now propose to test the efficacy of a
non-pharmacological reduction treatment for two reasons. First, many smokers are not willing
to use NRT for reduction. Another reason for testing a non-pharmacological treatment for
reduction is that prior studies of NRT- aided reduction have been interpreted to indicate
that reducing cigs/day will increase later quitting; however, since many(but not all)recent
studies suggest pretreatment with NRT alone improves quitting, it is unclear whether
reduction or pretreatment is the cause of any increase quitting in prior studies.

We also propose a replication test of our 5 Rs intervention because, although the counseling
technique of reviewing Relevance, Risks, Rewards, Roadblocks, and Repeat (5R's) have been
part of the last two USPHS Guidelines (most recently updated in 2008), our search of PubMed,
PsychINFO, NIH RePorter (database of NIH grants) and clinicaltrials.gov in 11/11 indicates
no published and no current or planned test of the 5 Rs, other than our study (Carpenter et
al., 2004). Clearly, more than one test of the approach recommended for >80% of smokers who
are not ready to quit (Wewers, Stillman, Hartman, & Shopland, 2003) is needed. Another
reason for our replication test is that our prior Journal of Consulting and Clinical
Psychology (JCCP) study of the 5 Rs used a no treatment control group; thus, we wish to
increase clinical relevance and methodological rigor by employing a usual care comparison
condition.

Study Design Design and Rationale for Methodological Decisions: We will use a three-group
(n= 560 total)Randomized Control Trial (RCT) to test whether a reduction and a 5 Rs
motivational intervention each increases the incidence of a quit attempt (Table 2). The
reduction and 5 Rs interventions will be time-matched with an initial 15 min call at
baseline followed by two 10 min calls at 2 and 4 weeks later (total = 35 min). The usual
care condition will receive a brief (< 5 min) call and mailed information about risks of
smoking, self-quitting and treatment resources at the same time-points. Monitoring of
cigs/day and abstinence will be via weekly online questionnaires.

Timing of treatments and measure Counseling calls Usual care: at baseline only Reduction:
baseline, Week 2, Week 4 5Rs: baseline, Week 2, Week 4

Measures for all 3 groups--all asked weekly x 4 then monthly x 5 cigs/day quit attempts
abstinence mediators Subject Selection Subjects will be current smokers who do not plan to
quit in the near future; i.e., about 70% of all smokers, because the purpose of our
treatment is to prompt new quit attempts among ambivalent smokers.

Vulnerable Populations Not applicable

Number of Subjects 560 current smokers. We will consent 560 in an effort to have 516 who
complete at least one counselor call.