Not Quite Ready to Quit
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2013 |
| End Date: | August 2016 |
A Test of Two Clinical Methods to Prompt a Quit Attempt Among Smokers
In our communications with the public, the investigators will call this the Not Quite Ready
to Quit Smoking Study.
One new method to increase quit attempts is to have smokers reduce their cigs/day. The
investigators and others have shown that reduction aided by nicotine medications can
increase quit attempts and later abstinence among smokers not ready to quit. Because half of
smokers are reluctant to use nicotine medications for a non-cessation reason, the
investigators now propose to test whether reduction not aided by nicotine medications can be
effective. Another new method to increase quit attempts is motivational counseling. The
investigators previously found implementation of the brief United States Public Health
Service (USPHS) Guidelines 5 Rs motivational intervention via three 15 min phone calls can
provide a large increase in quitting (OR = 6.3); however, the investigators need to
replicate that result. A vendor will proactively email adult, daily smokers listed in a
consumer panel to recruit 560 smokers who do not plan to quit in the next month and
randomize them to a) reduction counseling without the aid of nicotine medications , b) brief
counseling guided by the USPHS 5 R's, or c) usual care. The first two conditions will be
delivered via brief counseling calls at study onset and then 2 and 4 weeks later (total = 35
min). The usual care condition will consist of a brief (< 5 min) phone intervention followed
by a quit guide. Our major hypothesis is that the incidence of quit attempts over the 6
months of the study will be greater in both the reduction and the motivational conditions
than in the usual care condition. A secondary hypothesis is that the increase in quit
attempts will lead to increased abstinence. Another secondary hypothesis is that beneficial
effects of both treatments will be mediated by increases in self-efficacy and intentions to
quit. A final hypothesis is that decreases in cigs/day and nicotine dependence will mediate
the efficacy of the reduction treatment but not the motivational treatment and, conversely,
that a shift in decisional balance will mediate the efficacy of the motivational treatment
but not of the reduction treatment.
to Quit Smoking Study.
One new method to increase quit attempts is to have smokers reduce their cigs/day. The
investigators and others have shown that reduction aided by nicotine medications can
increase quit attempts and later abstinence among smokers not ready to quit. Because half of
smokers are reluctant to use nicotine medications for a non-cessation reason, the
investigators now propose to test whether reduction not aided by nicotine medications can be
effective. Another new method to increase quit attempts is motivational counseling. The
investigators previously found implementation of the brief United States Public Health
Service (USPHS) Guidelines 5 Rs motivational intervention via three 15 min phone calls can
provide a large increase in quitting (OR = 6.3); however, the investigators need to
replicate that result. A vendor will proactively email adult, daily smokers listed in a
consumer panel to recruit 560 smokers who do not plan to quit in the next month and
randomize them to a) reduction counseling without the aid of nicotine medications , b) brief
counseling guided by the USPHS 5 R's, or c) usual care. The first two conditions will be
delivered via brief counseling calls at study onset and then 2 and 4 weeks later (total = 35
min). The usual care condition will consist of a brief (< 5 min) phone intervention followed
by a quit guide. Our major hypothesis is that the incidence of quit attempts over the 6
months of the study will be greater in both the reduction and the motivational conditions
than in the usual care condition. A secondary hypothesis is that the increase in quit
attempts will lead to increased abstinence. Another secondary hypothesis is that beneficial
effects of both treatments will be mediated by increases in self-efficacy and intentions to
quit. A final hypothesis is that decreases in cigs/day and nicotine dependence will mediate
the efficacy of the reduction treatment but not the motivational treatment and, conversely,
that a shift in decisional balance will mediate the efficacy of the motivational treatment
but not of the reduction treatment.
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)
A comparison of the two active conditions is not an objective of the study.
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.
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)
A comparison of the two active conditions is not an objective of the study.
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.
Inclusion Criteria:
- > 18 years old
- smoke > 10 cigs/day seven days/week,
- wants to stop at some point but have no plans to quit in the next month
- is able to read and write English
- is a US citizen or a permanent resident alien
- available for counseling calls before 20:00 Eastern Time
Exclusion Criteria:
- has reduced cigs/day by > 25% in the last month
- has used non-cigarette tobacco in the last month
- has used electronic cigarettes, nicotine replacement medications, varenicline or
bupropion in the last month
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