SmokingPhase 4ChanLightNCT01639560
Varenicline for Light Smokers
A Phase 4 study testing Varenicline in people with Smoking, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine if varenicline is effective in treating tobacco dependence in adults who smoke 5-10 cigarettes per day. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be ≥ 18 years of age;
- smokes 5 to 10 CPD for at least 6 months;
- express interest in quitting smoking;
- indicate ability to complete all study visits; and
- provide written informed consent to participate in the study.
- Subject is a female subject of non-childbearing potential or a female subject of childbearing potential - who is using contraceptives and has a negative pregnancy test result;
- Subject is in good health as determined by the investigator;
- Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments.
Who cannot join
- An active medical condition such as unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia;
- History of renal failure;
- Cancer [excluding non-melanoma skin cancer] not in remission;
- Psychosis or bipolar disorder;
- Current unstable or untreated moderate or severe depression as assessed by the CES-D;
- have, as defined by the C-SSRS (Columbia-Suicide Severity Rating Scale), current non-specific suicidal thoughts, or have a lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act.");
Show all 16Show fewer
- Substance dependence other than nicotine, defined as:
- Patient has a recent history (past month) of heavy alcohol consumption as defined by NIAAA: i. Men: More than 4 drinks on any day or 14 per week ii. Women: More than 3 drinks on any day or 7 per week. b. Use of cocaine, heroin, club drugs (i.e., MDMA/"ecstasy"), methamphetamine, or hallucinogens (e.g., LSD) at any time during the past month.
- Use of marijuana on a weekly basis for the past month
- An allergy to varenicline;
- Current use of a behavioral or pharmacologic tobacco dependence treatment and unwilling or unable to discontinue use;
- Another member of their household already participating in this study; and
- Current treatment with another investigational drug (within 30 days of study entry).
- Has an unstable medical condition;
- Subject has untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100;
- Women of child-bearing potential, or who are pregnant, lactating or likely to become pregnant during the trial and are unwilling to use an acceptable form of contraception during the medication phase will also be excluded. All female subjects of childbearing potential must have a negative pregnancy test and must agree to use approved contraception during participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if varenicline is effective in treating tobacco dependence in adults who smoke 5-10 cigarettes per day.
Read the detailed description
Nearly 50% of U.S. cigarette smokers smoke ≤ 10 cigarettes per day (CPD) and are considered "light smokers." Most light smokers will either maintain a chronic light smoking habit or increase their level of smoking during their lifetime. Importantly, light smokers are at risk for adverse health consequences and increased all-cause mortality. While multiple factors such as reinforcement behavior, diminished autonomy, economic constraints and tobacco control policies influence light smoking, nicotine dependence appears particularly important in 5 to 10 CPD smokers. Despite the high prevalence of light smoking and its increased healthcare burden, few studies have evaluated the efficacy of pharmacotherapy for this group of smokers. Varenicline, which targets symptoms of nicotine dependence, has been shown to increase smoking abstinence rates in moderate to heavy smokers (≥ 10 cigarettes per day). However, varenicline has not been evaluated in subjects who smoke < 10 CPD. In the current proposal we will investigate the efficacy of varenicline for smoking cessation in 5 to 10 CPD light smokers who wish to quit. This study will be conducted as a double-blind, placebo-controlled, randomized clinical trial at the Mayo Clinic, enrolling 224 eligible participants who smoke 5 to 10 CPD. Participants will receive behavior therapy and either varenicline or placebo for 12 weeks with follow up through 26 weeks. We will determine if varenicline increases smoking abstinence in light smokers at end-of-treatment and 26 weeks as compared to placebo.
- Conditions
- Smoking
- Being tested
- Varenicline, Placebo
- Keywords
- smoking, tobacco dependence, nicotine dependence
- Medical subject headings
- Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called chantix
1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling
PlaceboDrug
Also called sugar pill
1 placebo tablet twice per day for 12 weeks and brief behavioral counseling
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Active comparator | 1 mg of varenicline twice per day for 12 weeks. Receives: Drug: Varenicline |
| placebo | Placebo comparator | 1 placebo tablet twice a day for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point Prevalence Smoking Outcome at 12 Weeks (End of Treatment)
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Point prevalence is defined as no smoking in the past 7 days.
Measured: 12 weeks
Prolonged Smoking Outcome at 12 Weeks (End of Treatment)
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.
Measured: 12 weeks
Secondary outcomes (2)
Point Prevalence Smoking Outcome at 24 Weeks (End of Study)
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Point prevalence is defined as no smoking in the past 7 days.
Measured: 24 weeks
Prolonged Smoking Outcome at 24 Weeks (End of Study)
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Jon Ebbert, Mayo Clinic
- Investigators
- Jon O. Ebbert, MD, Principal investigator, Mayo ClinicIvana T. Croghan, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639560
- Sponsor's protocol ID
- 12-005652
- Other IDs
- WS2293926
- Acronym
- ChanLight
- Status last verified
- Jan 2018
- First submitted
- 10 Jul 2012
- Last updated
- 22 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ebbert JO, Croghan IT, Hurt RT, Schroeder DR, Hays JT. Varenicline for Smoking Cessation in Light Smokers. Nicotine Tob Res. 2016 Oct;18(10):2031-5. doi: 10.1093/ntr/ntw123. Epub 2016 Apr 26.
PubMed 27117285
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline for Light Smokers
- ClinicalTrials.gov ID
- NCT01639560
- Acronym / sponsor ID
- ChanLight / 12-005652
- Conditions
- Smoking
- Keywords
- smoking, tobacco dependence, nicotine dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Posted 13 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if varenicline is effective in treating tobacco dependence in adults who smoke 5-10 cigarettes per day.
Detailed description
Nearly 50% of U.S. cigarette smokers smoke ≤ 10 cigarettes per day (CPD) and are considered "light smokers." Most light smokers will either maintain a chronic light smoking habit or increase their level of smoking during their lifetime. Importantly, light smokers are at risk for adverse health consequences and increased all-cause mortality. While multiple factors such as reinforcement behavior, diminished autonomy, economic constraints and tobacco control policies influence light smoking, nicotine dependence appears particularly important in 5 to 10 CPD smokers. Despite the high prevalence of light smoking and its increased healthcare burden, few studies have evaluated the efficacy of pharmacotherapy for this group of smokers. Varenicline, which targets symptoms of nicotine dependence, has been shown to increase smoking abstinence rates in moderate to heavy smokers (≥ 10 cigarettes per day). However, varenicline has not been evaluated in subjects who smoke < 10 CPD. In the current proposal we will investigate the efficacy of varenicline for smoking cessation in 5 to 10 CPD light smokers who wish to quit. This study will be conducted as a double-blind, placebo-controlled, randomized clinical trial at the Mayo Clinic, enrolling 224 eligible participants who smoke 5 to 10 CPD. Participants will receive behavior therapy and either varenicline or placebo for 12 weeks with follow up through 26 weeks. We will determine if varenicline increases smoking abstinence in light smokers at end-of-treatment and 26 weeks as compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Active comparator | Drug: Varenicline1 mg of varenicline twice per day for 12 weeks. |
| placebo | Placebo comparator | Drug: Placebo1 placebo tablet twice a day for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be ≥ 18 years of age;
- smokes 5 to 10 CPD for at least 6 months;
- express interest in quitting smoking;
- indicate ability to complete all study visits; and
- provide written informed consent to participate in the study.
Key exclusion criteria (16 listed)
- An active medical condition such as unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia;
- History of renal failure;
- Cancer [excluding non-melanoma skin cancer] not in remission;
- Psychosis or bipolar disorder;
- Current unstable or untreated moderate or severe depression as assessed by the CES-D;
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 |
|---|---|---|
| VareniclineAlso: chantix1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling | Drug | Varenicline |
| PlaceboAlso: sugar pill1 placebo tablet twice per day for 12 weeks and brief behavioral counseling | Drug | placebo |
Primary outcome
Point Prevalence Smoking Outcome at 12 Weeks (End of Treatment)
Time frame: 12 weeks
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Point prevalence is defined as no smoking in the past 7 days.
Prolonged Smoking Outcome at 12 Weeks (End of Treatment)
Time frame: 12 weeks
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.
2 secondary outcomes
Point Prevalence Smoking Outcome at 24 Weeks (End of Study)
Time frame: 24 weeks
Prolonged Smoking Outcome at 24 Weeks (End of Study)
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27117285Ebbert JO, Croghan IT, Hurt RT, Schroeder DR, Hays JT. Varenicline for Smoking Cessation in Light Smokers. Nicotine Tob Res. 2016 Oct;18(10):2031-5. doi: 10.1093/ntr/ntw123. Epub 2016 Apr 26.
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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.
Jon O. Ebbert, MD principal investigator
Mayo Clinic
Ivana T. Croghan, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline in people with Smoking, run by Mayo Clinic 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 8 inclusion and 16 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 22 Feb 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Point Prevalence Smoking Outcome at 12 Weeks (End of Treatment) (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT01639560, which also lists 1 linked publication.
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 22 Feb 2018.