SmokingPhase 4NCT02681510
UW-CTRI Triple Medication Smoking Cessation Study
A Phase 4 study testing Varenicline, Nicotine Transdermal Patch and Nicotine Mini in people with Smoking, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study will focus on enhancing future smoking cessation treatment effectiveness by piloting a potentially more powerful combination of three FDA-approved pharmacotherapies: varenicline plus combination of two types of nicotine replacement therapy (NRT) treatment (nicotine lozenge and nicotine patch). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Varenicline, Nicotine Transdermal Patch and Nicotine Mini
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 13 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >17 years;
- >=5 cigarettes/day for the previous 6 months;
- alveolar CO >= 6 ppm; able to read, write and speak English;
- planning to remain in the intervention catchment area for at least 4 months; not currently taking bupropion or varenicline;
- if the participant is currently using NRT, s/he agrees to use only study medication for the duration of the study;
- free of medical contraindications to NRT and varenicline; and,
- if participant is a woman of childbearing potential, using an approved method of birth control during treatment.
Who cannot join
- Current diagnosis of/treatment for psychosis or bipolar disorder;
- suicidal ideation within the past 12 months; any history of suicide attempts; * significant hepatic or renal impairment; history of significant allergic reactions to varenicline or any type of NRT in the past;
- use of any investigational drugs in the previous 30 days. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: UW-CTRI Smoking Cessation Medication Tolerability Study
This study will focus on enhancing future smoking cessation treatment effectiveness by piloting a potentially more powerful combination of three FDA-approved pharmacotherapies: varenicline plus combination of two types of nicotine replacement therapy (NRT) treatment (nicotine lozenge and nicotine patch). Data from this pilot study will help inform the design of future studies that would use this combination treatment as a cessation tool within the chronic care arsenal of treatments.
Read the detailed description
Recent research suggests that a new combination therapy may be especially effective in increasing long-term abstinence from smoking. A key purpose of the proposed study is to examine what types of tolerability concerns, if any, emerge from the simultaneous use of three FDA-approved cessation medications (varenicline, nicotine patch, and nicotine lozenge) and the timing of those events, in order to better assess how the use of this combination of tobacco cessation medicines can be most effectively and safely delivered and monitored. Study participants will take the three medications for 12 weeks in a manner consistent with labeling. Adverse events will be assessed at all study visits.
- Conditions
- Smoking
- Being tested
- Varenicline, Nicotine Transdermal Patch, Nicotine Mini
- Keywords
- medication tolerability
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
Standard FDA approved 12 weeks of treatment with Varenicline
Nicotine Transdermal PatchDrug
Standard FDA approved 12 weeks of treatment with Nicotine Transdermal Patch
Nicotine MiniDrug
Also called Nicotine Mini-Lozenge
Standard FDA approved 12 weeks of treatment with Nicotine Mini-Lozenge
| Study group | Role | What they receive |
|---|---|---|
| Three drug intervention | Experimental | varenicline, nicotine patch and nicotine lozenge for 12 weeks Receives: Drug: Varenicline; Drug: Nicotine Transdermal Patch; Drug: Nicotine Mini |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Assess adverse event rates in relation to participant ability to continue use of all 3 medications throughout the treatment period
Measured: 12 weeks
Secondary outcomes (3)
Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms
Satisfaction with Medications' Ability to Control Withdrawal Symptoms assessed on a 1-10 Likert Scale (higher value=greater satisfaction)
Measured: Week 12
Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking
Participant Satisfaction with Medications' Ability to Help Participant Quit Smoking assessed on a 1-10 Likert Scale (higher value=greater satisfaction)
Measured: Week 12
Number of Participants Who Reported Quitting at the End of Treatment
Self-reported Quit Rate at End of Treatment (12 Weeks); assessed as no smoking in the 7 days prior to the Week 12 follow-up call
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion13 Jun 2016
- Study completion13 Jun 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 University of Wisconsin, MadisonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael C Fiore, Principal investigator, University of Wisconsin--CTRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681510
- Sponsor's protocol ID
- UW 2015-1376
- Status last verified
- Sep 2017
- First submitted
- 9 Feb 2016
- Last updated
- 11 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Berg KM, Jorenby DE, Baker TB, Fiore MC. Triple Smoking Cessation Therapy with Varenicline, Nicotine Patch and Nicotine Lozenge: A Pilot Study to Assess Tolerability, Satisfaction, and End-of-Treatment Quit Rates. J Smok Cessat. 2018 Sep;13(3):145-153. doi: 10.1017/jsc.2017.18. Epub 2017 Sep 25.
PubMed 30524509
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UW-CTRI Smoking Cessation Medication Tolerability Study
- ClinicalTrials.gov ID
- NCT02681510
- Acronym / sponsor ID
- UW 2015-1376
- Conditions
- Smoking
- Keywords
- medication tolerability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 13 Jun 2016 (actual)
- Study completion
- 13 Jun 2016 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Posted 11 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will focus on enhancing future smoking cessation treatment effectiveness by piloting a potentially more powerful combination of three FDA-approved pharmacotherapies: varenicline plus combination of two types of nicotine replacement therapy (NRT) treatment (nicotine lozenge and nicotine patch). Data from this pilot study will help inform the design of future studies that would use this combination treatment as a cessation tool within the chronic care arsenal of treatments.
Detailed description
Recent research suggests that a new combination therapy may be especially effective in increasing long-term abstinence from smoking. A key purpose of the proposed study is to examine what types of tolerability concerns, if any, emerge from the simultaneous use of three FDA-approved cessation medications (varenicline, nicotine patch, and nicotine lozenge) and the timing of those events, in order to better assess how the use of this combination of tobacco cessation medicines can be most effectively and safely delivered and monitored. Study participants will take the three medications for 12 weeks in a manner consistent with labeling. Adverse events will be assessed at all study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three drug intervention | Experimental | Drug: Varenicline, Drug: Nicotine Transdermal Patch, Drug: Nicotine Minivarenicline, nicotine patch and nicotine lozenge for 12 weeks |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >17 years;
- >=5 cigarettes/day for the previous 6 months;
- alveolar CO >= 6 ppm; able to read, write and speak English;
- planning to remain in the intervention catchment area for at least 4 months; not currently taking bupropion or varenicline;
- if the participant is currently using NRT, s/he agrees to use only study medication for the duration of the study;
Key exclusion criteria (3 listed)
- Current diagnosis of/treatment for psychosis or bipolar disorder;
- suicidal ideation within the past 12 months; any history of suicide attempts; * significant hepatic or renal impairment; history of significant allergic reactions to varenicline or any type of NRT in the past;
- use of any investigational drugs in the previous 30 days. -
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: ChantixStandard FDA approved 12 weeks of treatment with Varenicline | Drug | Three drug intervention |
| Nicotine Transdermal PatchStandard FDA approved 12 weeks of treatment with Nicotine Transdermal Patch | Drug | Three drug intervention |
| Nicotine MiniAlso: Nicotine Mini-LozengeStandard FDA approved 12 weeks of treatment with Nicotine Mini-Lozenge | Drug | Three drug intervention |
Primary outcome
Number of Participants With Adverse Events
Time frame: 12 weeks
Assess adverse event rates in relation to participant ability to continue use of all 3 medications throughout the treatment period
3 secondary outcomes
Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms
Time frame: Week 12
Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking
Time frame: Week 12
Number of Participants Who Reported Quitting at the End of Treatment
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30524509Berg KM, Jorenby DE, Baker TB, Fiore MC. Triple Smoking Cessation Therapy with Varenicline, Nicotine Patch and Nicotine Lozenge: A Pilot Study to Assess Tolerability, Satisfaction, and End-of-Treatment Quit Rates. J Smok Cessat. 2018 Sep;13(3):145-153. doi: 10.1017/jsc.2017.18. Epub 2017 Sep 25.
- Individual participant dataSharing planned: Undecided
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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.
Michael C Fiore principal investigator
University of Wisconsin--CTRI
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, Nicotine Transdermal Patch and Nicotine Mini in people with Smoking, run by University of Wisconsin, Madison 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 7 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 11 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 11 Oct 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?
Number of Participants With Adverse Events (time frame: 12 weeks). 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 NCT02681510, 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 11 Oct 2017.