Smoking CessationNCT01866722
Not Quite Ready to Quit
A study testing Reduction and 5Rs in people with Smoking Cessation, run by University of Vermont at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Reduction and 5Rs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 14 Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Smoking Cessation
- Being tested
- Usual care, Reduction, 5Rs
- Keywords
- nicotine dependence, smoking cessation, lapse, relapse, tobacco, quit attempts, abstinence, motivation, reduction
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careBehavioural
Participants will get a brief (<5 min) telephone counseling session about quitting. After that, printed materials with resources to help quitting will be mailed to the participants.
ReductionBehavioural
Participants will have 3 telephone counseling sessions that focus on ways to reduce tobacco cigarette smoking. After the final session printed materials with resources to help quitting will be mailed to the participants.
5RsBehavioural
Participants will have 3 telephone counseling sessions that focus on the 5Rs for quitting tobacco cigarette smoking (Relevance, Risks, Rewards, Roadblocks, Repeat). After the final session printed materials with resources to help quitting will be mailed to the participants.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Participants will get a brief (<5 min) telephone counseling session about quitting. After that, printed materials with resources to help quitting will be mailed to the participants. Receives: Behavioral: Usual care |
| Reduction | Active comparator | Participants will have 3 telephone counseling sessions that focus on ways to reduce tobacco cigarette smoking. After the final session printed materials with resources to help quitting will be mailed to the participants. Receives: Behavioral: Reduction |
| 5Rs | Active comparator | Participants will have 3 telephone counseling sessions that focus on the 5Rs for quitting tobacco cigarette smoking (Relevance, Risks, Rewards, Roadblocks, Repeat). After the final session printed materials with resources to help quitting will be mailed to the participants. Receives: Behavioral: 5Rs |
What is being measured
The primary outcome is the main question the study is designed to answer.
quit attempts
The incidence of an attempt to quit smoking tobacco cigarettes during the 6 months of the study.
Measured: About 2 years
Secondary outcomes (1)
abstinence
7 day point prevalence abstinence from smoking tobacco cigarettes at 6 months after the beginning of treatment.
Measured: About 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startSep 2013
- Primary completion10 Jan 2015
- Study completion14 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, John Hughes, University of Vermont
- Investigators
- John R Hughes, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866722
- Sponsor's protocol ID
- CHRBS B12-268
- Other IDs
- R01CA163176
- Status last verified
- Jul 2017
- First submitted
- 22 May 2013
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wewers ME, Stillman FA, Hartman AM, Shopland DR. Distribution of daily smokers by stage of change: Current Population Survey results. Prev Med. 2003 Jun;36(6):710-20. doi: 10.1016/s0091-7435(03)00044-6.
PubMed 12744915Carpenter MJ, Hughes JR, Keely JP. Effect of smoking reduction on later cessation: a pilot experimental study. Nicotine Tob Res. 2003 Apr;5(2):155-62. doi: 10.1080/146222003100007385.
PubMed 12745487Klemperer EM, Hughes JR, Solomon LJ, Callas PW, Fingar JR. Motivational, reduction and usual care interventions for smokers who are not ready to quit: a randomized controlled trial. Addiction. 2017 Jan;112(1):146-155. doi: 10.1111/add.13594. Epub 2016 Oct 5.
PubMed 27566993
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Test of Two Clinical Methods to Prompt a Quit Attempt Among Smokers
- ClinicalTrials.gov ID
- NCT01866722
- Acronym / sponsor ID
- CHRBS B12-268
- Conditions
- Smoking Cessation
- Keywords
- nicotine dependence, smoking cessation, lapse, relapse, tobacco, quit attempts, abstinence, motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2013 (actual)
- Primary completion
- 10 Jan 2015 (actual)
- Study completion
- 14 Jul 2015 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual careParticipants will get a brief (<5 min) telephone counseling session about quitting. After that, printed materials with resources to help quitting will be mailed to the participants. |
| Reduction | Active comparator | Behavioral: ReductionParticipants will have 3 telephone counseling sessions that focus on ways to reduce tobacco cigarette smoking. After the final session printed materials with resources to help quitting will be mailed to the participants. |
| 5Rs | Active comparator | Behavioral: 5RsParticipants will have 3 telephone counseling sessions that focus on the 5Rs for quitting tobacco cigarette smoking (Relevance, Risks, Rewards, Roadblocks, Repeat). After the final session printed materials with resources to help quitting will be mailed to the participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careParticipants will get a brief (<5 min) telephone counseling session about quitting. After that, printed materials with resources to help quitting will be mailed to the participants. | Behavioural | Usual Care |
| ReductionParticipants will have 3 telephone counseling sessions that focus on ways to reduce tobacco cigarette smoking. After the final session printed materials with resources to help quitting will be mailed to the participants. | Behavioural | Reduction |
| 5RsParticipants will have 3 telephone counseling sessions that focus on the 5Rs for quitting tobacco cigarette smoking (Relevance, Risks, Rewards, Roadblocks, Repeat). After the final session printed materials with resources to help quitting will be mailed to the participants. | Behavioural | 5Rs |
Primary outcome
quit attempts
Time frame: About 2 years
The incidence of an attempt to quit smoking tobacco cigarettes during the 6 months of the study.
1 secondary outcome
abstinence
Time frame: About 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Background: PubMed 12744915Wewers ME, Stillman FA, Hartman AM, Shopland DR. Distribution of daily smokers by stage of change: Current Population Survey results. Prev Med. 2003 Jun;36(6):710-20. doi: 10.1016/s0091-7435(03)00044-6.
- Background: PubMed 12745487Carpenter MJ, Hughes JR, Keely JP. Effect of smoking reduction on later cessation: a pilot experimental study. Nicotine Tob Res. 2003 Apr;5(2):155-62. doi: 10.1080/146222003100007385.
- Results publication: PubMed 27566993Klemperer EM, Hughes JR, Solomon LJ, Callas PW, Fingar JR. Motivational, reduction and usual care interventions for smokers who are not ready to quit: a randomized controlled trial. Addiction. 2017 Jan;112(1):146-155. doi: 10.1111/add.13594. Epub 2016 Oct 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Hughes, MD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduction and 5Rs in people with Smoking Cessation, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quit attempts (time frame: About 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01866722, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.