Tobacco Use DisorderPhase 2NCT01050569
Innovative Interventions for Smoking Cessation
A Phase 2 study testing Nicotine Patch, VLNC Cigarette and VLNC Cigarette Plus Nicotine Patch in people with Tobacco Use Disorder, run by University of Minnesota at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Nicotine Patch, VLNC Cigarette and VLNC Cigarette Plus Nicotine Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Jun 2012
- Phase
- Phase 2
- 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
- a) Smoking at least 10 cigarettes daily for the past year;
- b) In good physical health;
- c) No contraindications for medicinal nicotine; and
- d) Stable, good mental health.
Who cannot join
- a) Subjects must not be using other tobacco or nicotine products.
- b) Female subjects cannot be pregnant or nursing and must be using appropriate birth control.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota
Duluth, Minnesota, 55812
University of MN's Tobacco Use Research Center
Minneapolis, Minnesota, 55414
About this study
Official title: Innovative Interventions for Smoking Cessation: Comparison of Very Low Nicotine Content Cigarettes Plus Nicotine Patch; Very Low Nicotine Content Cigarettes Alone or Nicotine Patch Alone
The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. The study will determine if adding nicotine replacement medication to the very low content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.
Read the detailed description
The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content cigarette (VLNC) compared to the VLNC cigarette alone or 21 mg nicotine patch alone on abstinence, time to relapse and toxicant levels.
The following primary hypothesis will be tested:
Abstinence rates will be highest and the time to relapse will be the longest in the VLNC cigarettes plus nicotine patch condition compared to nicotine patch or VLNC cigarettes alone.
Other hypotheses include:
- Greater positive subjective responses to cigarettes will be observed with VLNC cigarettes plus patch vs. VLNC cigarette;
- Less drop-outs will be observed in the VLNC plus patch vs the other two conditions; and
- Less compensatory smoking will be observed in the VLNC plus patch condition compared to VLNC cigarette alone condition.
Cigarette smokers will be randomized to:
- VLNC cigarettes (which provide sensory behavioral aspects of smoking but with limited nicotine) plus nicotine patch for 6 weeks;
- Nicotine patch for 6 weeks; or
- VLNC cigarettes alone.
Outcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, and biomarkers of toxicant exposure. Predictors of abstinence and treatment response for each of the treatment conditions will be explored.
- Conditions
- Tobacco Use Disorder
- Being tested
- Nicotine Patch, VLNC Cigarette, VLNC Cigarette Plus Nicotine Patch
- Keywords
- Smoking Cessation, Nicotine Free Cigarettes
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine PatchDrug
Also called Nicoderm CQ
21 mg
VLNC CigaretteOther
Also called Quest 3, Xodus
Cigarette where the tobacco contains <0.1 mg of nicotine yield.
VLNC Cigarette Plus Nicotine PatchOther
Also called Nicoderm CQ, Quest 3, Xodus
21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
| Study group | Role | What they receive |
|---|---|---|
| VLNC Cigarette | Active comparator | Very Low Nicotine Content Cigarette. Dosage: 0.05 mg to 0.09 mg nicotine yield cigarette; Frequency: Daily; Duration: 6 weeks. Receives: Other: VLNC Cigarette |
| Nicotine Patch | Active comparator | 21 mg nicotine patch. Dosage: 21 mg; Frequency: Daily; Duration: 6 weeks. Receives: Drug: Nicotine Patch |
| VLNC Cigarette plus Nicotine Patch | Experimental | Very Low Nicotine Content Cigarette plus 21 mg Nicotine Patch. Patch Dosage: 21 mg; Cigarette Dosasge: 0.05 to 0.09 mg nicotine yield; Frequency: Daily; Duration: 6 weeks Receives: Other: VLNC Cigarette Plus Nicotine Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of Treatment Abstinence Rate
Cotinine and carbon monoxide (CO) verified point prevalence abstinence
Measured: 12 week
End of Follow-up Abstinence Rates
CO- and cotinine-verified point prevalence abstinence
Measured: 36 weeks
Secondary outcomes (2)
Exposure to Tobacco Toxicants
Measured: 6 weeks
Time to Lapse or Relapse to Tobacco Use
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startOct 2008
- Primary completionDec 2011
- Study completionJun 2012
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 (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Dorothy Hatsukami, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050569
- Sponsor's protocol ID
- 0409M63686
- Other IDs
- 1R01DA025598
- Status last verified
- Oct 2019
- First submitted
- 14 Jan 2010
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hatsukami DK, Hertsgaard LA, Vogel RI, Jensen JA, Murphy SE, Hecht SS, Carmella SG, al'Absi M, Joseph AM, Allen SS. Reduced nicotine content cigarettes and nicotine patch. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1015-24. doi: 10.1158/1055-9965.EPI-12-1439. Epub 2013 Apr 19.
PubMed 23603206Dermody SS, Donny EC, Hertsgaard LA, Hatsukami DK. Greater reductions in nicotine exposure while smoking very low nicotine content cigarettes predict smoking cessation. Tob Control. 2015 Nov;24(6):536-9. doi: 10.1136/tobaccocontrol-2014-051797. Epub 2014 Sep 5.
PubMed 25192771
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Interventions for Smoking Cessation: Comparison of Very Low Nicotine Content Cigarettes Plus Nicotine Patch; Very Low Nicotine Content Cigarettes Alone or Nicotine Patch Alone
- ClinicalTrials.gov ID
- NCT01050569
- Acronym / sponsor ID
- 0409M63686
- Conditions
- Tobacco Use Disorder
- Keywords
- Smoking Cessation, Nicotine Free Cigarettes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Posted 28 Feb 2014
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 evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. The study will determine if adding nicotine replacement medication to the very low content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.
Detailed description
The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content cigarette (VLNC) compared to the VLNC cigarette alone or 21 mg nicotine patch alone on abstinence, time to relapse and toxicant levels.
The following primary hypothesis will be tested:
Abstinence rates will be highest and the time to relapse will be the longest in the VLNC cigarettes plus nicotine patch condition compared to nicotine patch or VLNC cigarettes alone.
Other hypotheses include:
- Greater positive subjective responses to cigarettes will be observed with VLNC cigarettes plus patch vs. VLNC cigarette;
- Less drop-outs will be observed in the VLNC plus patch vs the other two conditions; and
- Less compensatory smoking will be observed in the VLNC plus patch condition compared to VLNC cigarette alone condition.
Cigarette smokers will be randomized to:
- VLNC cigarettes (which provide sensory behavioral aspects of smoking but with limited nicotine) plus nicotine patch for 6 weeks;
- Nicotine patch for 6 weeks; or
- VLNC cigarettes alone.
Outcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, and biomarkers of toxicant exposure. Predictors of abstinence and treatment response for each of the treatment conditions will be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VLNC Cigarette | Active comparator | Other: VLNC CigaretteVery Low Nicotine Content Cigarette. Dosage: 0.05 mg to 0.09 mg nicotine yield cigarette; Frequency: Daily; Duration: 6 weeks. |
| Nicotine Patch | Active comparator | Drug: Nicotine Patch21 mg nicotine patch. Dosage: 21 mg; Frequency: Daily; Duration: 6 weeks. |
| VLNC Cigarette plus Nicotine Patch | Experimental | Other: VLNC Cigarette Plus Nicotine PatchVery Low Nicotine Content Cigarette plus 21 mg Nicotine Patch. Patch Dosage: 21 mg; Cigarette Dosasge: 0.05 to 0.09 mg nicotine yield; Frequency: Daily; Duration: 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a) Smoking at least 10 cigarettes daily for the past year;
- b) In good physical health;
- c) No contraindications for medicinal nicotine; and
- d) Stable, good mental health.
Key exclusion criteria (2 listed)
- a) Subjects must not be using other tobacco or nicotine products.
- b) Female subjects cannot be pregnant or nursing and must be using appropriate birth control.
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 PatchAlso: Nicoderm CQ21 mg | Drug | Nicotine Patch |
| VLNC CigaretteAlso: Quest 3, XodusCigarette where the tobacco contains <0.1 mg of nicotine yield. | Other | VLNC Cigarette |
| VLNC Cigarette Plus Nicotine PatchAlso: Nicoderm CQ, Quest 3, Xodus21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield. | Other | VLNC Cigarette plus Nicotine Patch |
Primary outcome
End of Treatment Abstinence Rate
Time frame: 12 week
Cotinine and carbon monoxide (CO) verified point prevalence abstinence
End of Follow-up Abstinence Rates
Time frame: 36 weeks
CO- and cotinine-verified point prevalence abstinence
2 secondary outcomes
Exposure to Tobacco Toxicants
Time frame: 6 weeks
Time to Lapse or Relapse to Tobacco Use
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23603206Hatsukami DK, Hertsgaard LA, Vogel RI, Jensen JA, Murphy SE, Hecht SS, Carmella SG, al'Absi M, Joseph AM, Allen SS. Reduced nicotine content cigarettes and nicotine patch. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1015-24. doi: 10.1158/1055-9965.EPI-12-1439. Epub 2013 Apr 19.
- Derived from this study: PubMed 25192771Dermody SS, Donny EC, Hertsgaard LA, Hatsukami DK. Greater reductions in nicotine exposure while smoking very low nicotine content cigarettes predict smoking cessation. Tob Control. 2015 Nov;24(6):536-9. doi: 10.1136/tobaccocontrol-2014-051797. Epub 2014 Sep 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.
Dorothy Hatsukami, PhD principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotine Patch, VLNC Cigarette and VLNC Cigarette Plus Nicotine Patch in people with Tobacco Use Disorder, run by University of Minnesota at 2 sites 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 4 inclusion and 2 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 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Feb 2014). 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?
End of Treatment Abstinence Rate (time frame: 12 week). 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 NCT01050569, which also lists 2 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 18 Nov 2019.