Smoking CessationPhase 4NCT01807871
Treatment of Smoking Lapses and Relapses
A Phase 4 study testing nicotine patch, experimental use and nicotine patch, labeled use in people with Smoking Cessation, run by University of Vermont at 1 site in United States.
Trial summary
Many smokers who try to stop smoking with nicotine medications (NM) such as gum, lozenge and patch, go back to smoking (i.e., a slip or lapse). Currently, labeling on many NM products tells smokers who lapse while using NM to stop NM. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- nicotine patch, experimental use and nicotine patch, labeled use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 701 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Feb 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
- at least 18 years old
- daily smoker of 10 or more cigarettes per day for at least 1 year
- state they plan to probably or definitely quit smoking in the next month
- have a home or cell phone
- willing to use nicotine patch
- good command of written and spoken English
- weigh at least 100 pounds
- US citizen or permanent resident alien
Who cannot join
- use of non-cigarette tobacco in the last month
- use of a smoking cessation medication or smoking cessation counseling in the last month
- medical contraindication to use of patch
- other person in household already in our study
- previously a participant in the study
- currently pregnant or breast feeding
Show all 9Show fewer
- plan to become pregnant in the next 6 months
- regularly works the overnight shift
- use of electronic cigarettes in the last month
Trial locations and contacts
1 site in 1 country.
About this study
Many smokers who try to stop smoking with nicotine medications (NM) such as gum, lozenge and patch, go back to smoking (i.e., a slip or lapse). Currently, labeling on many NM products tells smokers who lapse while using NM to stop NM. However, some studies suggest it is safe to continue NM upon a lapse and that doing so dramatically increases success at quitting. The investigators will test this by doing a randomized trial in which all treatment and measures are done from home with paper, phone or computer surveys. The investigators will recruit smokers who want to quit, provide them with 10 weeks of nicotine patch treatment and 5 weeks of counseling. One group will be asked to stop use of the patch if they lapse and the other group will be asked to continue use of the patch if they lapse. The investigators will compare the groups on their success at quitting and side-effects.
Read the detailed description
Objectives:
To test our hypothesis that among the subset of the 770 enrolled participants who quit smoking and then lapsed while using the nicotine patch, those randomized to continue the patch post-lapse will be more likely to be 7-day point prevalent abstinent at 4-month follow-up than those randomized to discontinue the patch post-lapse.
To test whether the amount of patch use post-lapse, craving, withdrawal, cigs/day, motivation to quit, confidence in quitting, nicotine reinforcement from cigarettes, and self-efficacy mediate any effect of post-lapse patch use on abstinence.
To test whether the incidence of adverse events (AEs) during post-lapse patch use is minimal.
Purpose:
Over the counter (OTC) NRT is, by far, the most common treatment for smoking cessation in the United States (Cokkinides, Ward, Jemel, \& Thun, 2005). Over 80% of those using OTC NRT will lapse (Stead, Perera, Bullen, Mant, \& Lancaster, 2008). One possible reason for this high rate of relapse is that NRT package labeling states "do not use if you continue to smoke", and the majority of smokers believe this means it is best to stop using NRT upon a lapse; e.g., the only survey on real-world use of NRT during a lapse episode found that 77% of smokers discontinued NRT after a lapse (Pierce \& Gilpin, 2002). The investigators and others (Bader, McDonald, \& Selby, 2009) believe continuing NRT during a lapse episode will a) relieve craving and withdrawal (West \& Shiffman, 2001), b) block the reinforcing effects of smoking (Perkins, Fonte, Meeker, White, \& Wilson, 2001; Rose \& Behm, 2004), c) help smokers smoke less (Hughes \& Carpenter, 2005), and d) increase self-efficacy, all of which should help smokers re-establish abstinence.
Study design:
The investigators are proposing a parallel groups randomized controlled trial (RCT) in which all treatment and monitoring occur via phone, and medication via mail. The investigators will recruit about 770 smokers to receive phone counseling before and after the quit date and nicotine patches for 10 weeks after the quit date. At study entry, smokers will be randomized to a "Continue NRT" or a "Discontinue NRT" condition. The Continue NRT participants will be advised that, if they lapse, they should continue NRT. Smokers randomized to the Discontinue NRT condition will be advised that, if they lapse, they should discontinue NRT use. The messages will also include rationales. Messages will be delivered several times via written material, Interactive Voice Response (IVR) messages and during phone counseling. Participants will record cigs/day nightly via a phone-based IVR system for 10 weeks. If the IVR detects a lapse during the first 10 weeks of the study, it will encourage the participant to re-establish abstinence as soon as possible and repeat the condition-appropriate message about post-lapse NRT use. After the 10-week treatment period, the investigators will use monthly questionnaires (online or paper) to assess recent smoking, cigs/day, NRT use, and other stop-smoking medications.
Subject selection:
Men and women, minorities and children over 18 will be included. Pregnant and breastfeeding women, women who plan to become pregnant and those at risk for AEs from NRT will be excluded. Our goal is to recruit a sample of the same gender, ethnicity/race prevalence as that of US smokers interested in quitting; i.e. 52% men, 78% White/Non-Hispanic, 11% Black, 8% Hispanic and 3% other ethnicities/races (Hughes \& Callas, 2010). The investigators do not have data on which to estimate the percent who will be children between ages 18-21 but most studies suggest very few young smokers are interested in formal treatment (Sussman, 2002).
Number of subjects:
The investigators have chosen an initial inclusion of 770 smokers to obtain a sample size of 490 smokers who lapse on NRT.
- Conditions
- Smoking Cessation
- Being tested
- nicotine patch, experimental use, nicotine patch, labeled use
- Keywords
- nicotine dependence, smoking cessation, lapse, relapse, tobacco, nicotine patch, nicotine replacement therapy, NRT
- 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.
nicotine patch, experimental useDrug
Also called Nicoderm Clear 21 mg, Nicoderm Clear 14 mg, Nicoderm Clear 7 mg
nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch.
nicotine patch, labeled useDrug
Also called Nicoderm Clear 21 mg, Nicoderm Clear 14 mg, Nicoderm Clear 7 mg
nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling.
| Study group | Role | What they receive |
|---|---|---|
| nicotine patch, experimental use | Experimental | Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels. Receives: Drug: nicotine patch, experimental use |
| nicotine patch, labeled use | Active comparator | Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches. Receives: Drug: nicotine patch, labeled use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point-prevalent Abstinence at 4 Months
To test our hypothesis that among the subset of the 701 enrolled participants who quit smoking and then lapsed while using the nicotine patch, those randomized to continue the patch post-lapse will be more likely to be 7-day point-prevalent abstinent at 4 month follow-up than those randomized to discontinue the patch post-lapse. 7-day point prevalent abstinence was assessed by response to the question "In the last 7 days, on how many days did you smoke" on the 4 month follow-up survey. Respondents who replied "0" were classified as "Yes" for 7-day point-prevalent abstinence; all other responses (including missing) were classified as "No".
Measured: 4 months after the quit date
Secondary outcomes (2)
Mediators of Effect of Post-lapse Nicotine Replacement Therapy Use on Abstinence
To test whether the amount of use of nicotine patch post-lapse, craving, withdrawal, cigs/day, motivation to quit, confidence in quitting, nicotine reinforcement from cigarettes, and self-efficacy mediate any effect of post-lapse patch use on abstinence.
Measured: 4 months after the quit date
Adverse Drug Effects
To test whether the incidence of adverse drug effects during the post-lapse use of nicotine patch is minimal.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2016
- Study completionFeb 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 (10)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 701 participants (actual)
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
- NCT01807871
- Sponsor's protocol ID
- M12-113
- Other IDs
- R01CA165080
- Status last verified
- Sep 2017
- First submitted
- 4 Mar 2013
- Last updated
- 13 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cokkinides VE, Ward E, Jemal A, Thun MJ. Under-use of smoking-cessation treatments: results from the National Health Interview Survey, 2000. Am J Prev Med. 2005 Jan;28(1):119-22. doi: 10.1016/j.amepre.2004.09.007.
PubMed 15626567Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000146. doi: 10.1002/14651858.CD000146.pub3.
PubMed 18253970Pierce JP, Gilpin EA. Impact of over-the-counter sales on effectiveness of pharmaceutical aids for smoking cessation. JAMA. 2002 Sep 11;288(10):1260-4. doi: 10.1001/jama.288.10.1260.
PubMed 12215133Bader P, McDonald P, Selby P. An algorithm for tailoring pharmacotherapy for smoking cessation: results from a Delphi panel of international experts. Tob Control. 2009 Feb;18(1):34-42. doi: 10.1136/tc.2008.025635. Epub 2008 Oct 9.
PubMed 18845621West R, Shiffman S. Effect of oral nicotine dosing forms on cigarette withdrawal symptoms and craving: a systematic review. Psychopharmacology (Berl). 2001 May;155(2):115-22. doi: 10.1007/s002130100712.
PubMed 11400998Perkins KA, Fonte C, Meeker J, White W, Wilson A. The discriminative stimulus and reinforcing effects of nicotine in humans following nicotine pretreatment. Behav Pharmacol. 2001 Feb;12(1):35-44. doi: 10.1097/00008877-200102000-00004.
PubMed 11270510Hughes JR, Carpenter MJ. The feasibility of smoking reduction: an update. Addiction. 2005 Aug;100(8):1074-89. doi: 10.1111/j.1360-0443.2005.01174.x.
PubMed 16042638Sussman S. Effects of sixty six adolescent tobacco use cessation trials and seventeen prospective studies of self-initiated quitting. Tob Induc Dis. 2002 Jan 15;1(1):35-81. doi: 10.1186/1617-9625-1-1-35.
PubMed 19570247Hughes JR, Solomon LJ, Peasley-Miklus CE, Callas PW, Fingar JR. Effectiveness of continuing nicotine replacement after a lapse: A randomized trial. Addict Behav. 2018 Jan;76:68-81. doi: 10.1016/j.addbeh.2017.07.023. Epub 2017 Jul 14.
PubMed 28756042Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.
PubMed 37335995
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Smoking Lapses and Relapses
- ClinicalTrials.gov ID
- NCT01807871
- Acronym / sponsor ID
- M12-113
- Conditions
- Smoking Cessation
- Keywords
- nicotine dependence, smoking cessation, lapse, relapse, tobacco, nicotine patch, nicotine replacement therapy, NRT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 701 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Posted 28 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many smokers who try to stop smoking with nicotine medications (NM) such as gum, lozenge and patch, go back to smoking (i.e., a slip or lapse). Currently, labeling on many NM products tells smokers who lapse while using NM to stop NM. However, some studies suggest it is safe to continue NM upon a lapse and that doing so dramatically increases success at quitting. The investigators will test this by doing a randomized trial in which all treatment and measures are done from home with paper, phone or computer surveys. The investigators will recruit smokers who want to quit, provide them with 10 weeks of nicotine patch treatment and 5 weeks of counseling. One group will be asked to stop use of the patch if they lapse and the other group will be asked to continue use of the patch if they lapse. The investigators will compare the groups on their success at quitting and side-effects.
Detailed description
Objectives:
To test our hypothesis that among the subset of the 770 enrolled participants who quit smoking and then lapsed while using the nicotine patch, those randomized to continue the patch post-lapse will be more likely to be 7-day point prevalent abstinent at 4-month follow-up than those randomized to discontinue the patch post-lapse.
To test whether the amount of patch use post-lapse, craving, withdrawal, cigs/day, motivation to quit, confidence in quitting, nicotine reinforcement from cigarettes, and self-efficacy mediate any effect of post-lapse patch use on abstinence.
To test whether the incidence of adverse events (AEs) during post-lapse patch use is minimal.
Purpose:
Over the counter (OTC) NRT is, by far, the most common treatment for smoking cessation in the United States (Cokkinides, Ward, Jemel, \& Thun, 2005). Over 80% of those using OTC NRT will lapse (Stead, Perera, Bullen, Mant, \& Lancaster, 2008). One possible reason for this high rate of relapse is that NRT package labeling states "do not use if you continue to smoke", and the majority of smokers believe this means it is best to stop using NRT upon a lapse; e.g., the only survey on real-world use of NRT during a lapse episode found that 77% of smokers discontinued NRT after a lapse (Pierce \& Gilpin, 2002). The investigators and others (Bader, McDonald, \& Selby, 2009) believe continuing NRT during a lapse episode will a) relieve craving and withdrawal (West \& Shiffman, 2001), b) block the reinforcing effects of smoking (Perkins, Fonte, Meeker, White, \& Wilson, 2001; Rose \& Behm, 2004), c) help smokers smoke less (Hughes \& Carpenter, 2005), and d) increase self-efficacy, all of which should help smokers re-establish abstinence.
Study design:
The investigators are proposing a parallel groups randomized controlled trial (RCT) in which all treatment and monitoring occur via phone, and medication via mail. The investigators will recruit about 770 smokers to receive phone counseling before and after the quit date and nicotine patches for 10 weeks after the quit date. At study entry, smokers will be randomized to a "Continue NRT" or a "Discontinue NRT" condition. The Continue NRT participants will be advised that, if they lapse, they should continue NRT. Smokers randomized to the Discontinue NRT condition will be advised that, if they lapse, they should discontinue NRT use. The messages will also include rationales. Messages will be delivered several times via written material, Interactive Voice Response (IVR) messages and during phone counseling. Participants will record cigs/day nightly via a phone-based IVR system for 10 weeks. If the IVR detects a lapse during the first 10 weeks of the study, it will encourage the participant to re-establish abstinence as soon as possible and repeat the condition-appropriate message about post-lapse NRT use. After the 10-week treatment period, the investigators will use monthly questionnaires (online or paper) to assess recent smoking, cigs/day, NRT use, and other stop-smoking medications.
Subject selection:
Men and women, minorities and children over 18 will be included. Pregnant and breastfeeding women, women who plan to become pregnant and those at risk for AEs from NRT will be excluded. Our goal is to recruit a sample of the same gender, ethnicity/race prevalence as that of US smokers interested in quitting; i.e. 52% men, 78% White/Non-Hispanic, 11% Black, 8% Hispanic and 3% other ethnicities/races (Hughes \& Callas, 2010). The investigators do not have data on which to estimate the percent who will be children between ages 18-21 but most studies suggest very few young smokers are interested in formal treatment (Sussman, 2002).
Number of subjects:
The investigators have chosen an initial inclusion of 770 smokers to obtain a sample size of 490 smokers who lapse on NRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nicotine patch, experimental use | Experimental | Drug: nicotine patch, experimental useParticipants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels. |
| nicotine patch, labeled use | Active comparator | Drug: nicotine patch, labeled useParticipants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- at least 18 years old
- daily smoker of 10 or more cigarettes per day for at least 1 year
- state they plan to probably or definitely quit smoking in the next month
- have a home or cell phone
- willing to use nicotine patch
Key exclusion criteria (9 listed)
- use of non-cigarette tobacco in the last month
- use of a smoking cessation medication or smoking cessation counseling in the last month
- medical contraindication to use of patch
- other person in household already in our study
- previously a participant in the study
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 |
|---|---|---|
| nicotine patch, experimental useAlso: Nicoderm Clear 21 mg, Nicoderm Clear 14 mg, Nicoderm Clear 7 mgnicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch. | Drug | nicotine patch, experimental use |
| nicotine patch, labeled useAlso: Nicoderm Clear 21 mg, Nicoderm Clear 14 mg, Nicoderm Clear 7 mgnicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling. | Drug | nicotine patch, labeled use |
Primary outcome
Point-prevalent Abstinence at 4 Months
Time frame: 4 months after the quit date
To test our hypothesis that among the subset of the 701 enrolled participants who quit smoking and then lapsed while using the nicotine patch, those randomized to continue the patch post-lapse will be more likely to be 7-day point-prevalent abstinent at 4 month follow-up than those randomized to discontinue the patch post-lapse. 7-day point prevalent abstinence was assessed by response to the question "In the last 7 days, on how many days did you smoke" on the 4 month follow-up survey. Respondents who replied "0" were classified as "Yes" for 7-day point-prevalent abstinence; all other responses (including missing) were classified as "No".
2 secondary outcomes
Mediators of Effect of Post-lapse Nicotine Replacement Therapy Use on Abstinence
Time frame: 4 months after the quit date
Adverse Drug Effects
Time frame: Up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15626567Cokkinides VE, Ward E, Jemal A, Thun MJ. Under-use of smoking-cessation treatments: results from the National Health Interview Survey, 2000. Am J Prev Med. 2005 Jan;28(1):119-22. doi: 10.1016/j.amepre.2004.09.007.
- Background: PubMed 18253970Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000146. doi: 10.1002/14651858.CD000146.pub3.
- Background: PubMed 12215133Pierce JP, Gilpin EA. Impact of over-the-counter sales on effectiveness of pharmaceutical aids for smoking cessation. JAMA. 2002 Sep 11;288(10):1260-4. doi: 10.1001/jama.288.10.1260.
- Background: PubMed 18845621Bader P, McDonald P, Selby P. An algorithm for tailoring pharmacotherapy for smoking cessation: results from a Delphi panel of international experts. Tob Control. 2009 Feb;18(1):34-42. doi: 10.1136/tc.2008.025635. Epub 2008 Oct 9.
- Background: PubMed 11400998West R, Shiffman S. Effect of oral nicotine dosing forms on cigarette withdrawal symptoms and craving: a systematic review. Psychopharmacology (Berl). 2001 May;155(2):115-22. doi: 10.1007/s002130100712.
- Background: PubMed 11270510Perkins KA, Fonte C, Meeker J, White W, Wilson A. The discriminative stimulus and reinforcing effects of nicotine in humans following nicotine pretreatment. Behav Pharmacol. 2001 Feb;12(1):35-44. doi: 10.1097/00008877-200102000-00004.
- Background: PubMed 16042638Hughes JR, Carpenter MJ. The feasibility of smoking reduction: an update. Addiction. 2005 Aug;100(8):1074-89. doi: 10.1111/j.1360-0443.2005.01174.x.
- Background: PubMed 19570247Sussman S. Effects of sixty six adolescent tobacco use cessation trials and seventeen prospective studies of self-initiated quitting. Tob Induc Dis. 2002 Jan 15;1(1):35-81. doi: 10.1186/1617-9625-1-1-35.
- Results publication: PubMed 28756042Hughes JR, Solomon LJ, Peasley-Miklus CE, Callas PW, Fingar JR. Effectiveness of continuing nicotine replacement after a lapse: A randomized trial. Addict Behav. 2018 Jan;76:68-81. doi: 10.1016/j.addbeh.2017.07.023. Epub 2017 Jul 14.
- Derived from this study: PubMed 37335995Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.
- Individual participant dataSharing planned: No
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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 Phase 4 study testing nicotine patch, experimental use and nicotine patch, labeled use 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 8 inclusion and 9 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 13 Oct 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.
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 28 Mar 2017). 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-prevalent Abstinence at 4 Months (time frame: 4 months after the quit date). 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 NCT01807871, which also lists 10 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 13 Oct 2017.