Cigarette SmokingPhase 3CON NIC IINCT00734617
Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II
A Phase 3 study testing Nicotine Patch in people with Cigarette Smoking, run by Duke University at 1 site in United States.
Trial summary
The main goals of the study are to assess benefits of higher doses of the nicotine patch prior to smoking cessation for high- and low-dependent smokers, and to investigate the potential relationship between genetic factors and smoking cessation success. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Nicotine Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 479 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to May 2009
- Phase
- Phase 3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be 18-65 years old, have smoked an average of at least 10 cigarettes per day for three cumulative or continuous years of a brand that delivers (by Federal Trade Commission rated yields) at least 0.5 mg nicotine, have an expired air carbon monoxide reading of at least 10 ppm, and express a desire to quit smoking. Additionally, subjects must express a willingness to switch to denicotinized cigarettes. A more dependent smoker is defined as someone with an FTND score of seven or greater. A less dependent smoker is defined as someone with an FTND score of less than seven.
Who cannot join
- For those with a known history of hypertension, systolic >140 mm Hg, diastolic >100 mm Hg); hypotension (systolic <90 mm Hg, diastolic <60 mm Hg) Participants with hypertension or hypotension may, however, be allowed to participate in the study if the study physician or P.A. determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety. Subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100. Potential subjects who report coronary heart disease; heart attack; cardiac rhythm disorder (irregular heart rhythm); chest pains (unless history, exam, and EKG clearly indicate a non-cardiac source); cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure); history of skin allergy; active skin condition (psoriasis) within the last five years; skin disorder except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds.); liver or kidney disorder (except kidney stones, gallstones); gastrointestinal problems or disease other than gastroesophageal reflux or heartburn; ulcers; lung disorder (including but not limited to COPD, emphysema, and asthma); brain abnormality (including but not limited to, stroke, brain tumor, seizure disorder); history of fainting; problems giving blood samples; difficulty passing urine; diabetes treated with insulin, non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%); current cancer or treatment for cancer in the past 6 months(except basal or squamous cell skin cancer); other major medical condition; current psychiatric disease (with the exception of depression, anxiety disorders, OCD and ADHD) will be excluded from the study. Potential subjects who do not have a self reported diagnosis of the above listed conditions may be excluded if the study physician or P.A. determines that the history, physical findings, EKG, or laboratory studies reveal information that may jeopardize the subject's safe study participation.
- Potential subjects who have abused alcohol or drugs, or have used within the last 30 days experimental (investigational) drugs, psychiatric medications (including antidepressants, anti-psychotics) or any other medications that are known to affect smoking cessation (e.g. clonidine) will be excluded. Potential subjects who have used smokeless tobacco (chewing tobacco, snuff), cigars, pipes, nicotine replacement therapy, or other smoking cessation treatment within the last 2 weeks will be excluded. Pregnant or nursing mothers will be excluded.
- Use of non-opiate medications for pain or sleep will be allowed. For medical conditions that do not appear above, the study physician will be consulted and if the medical condition does not jeopardize safe study participation, then the subject may be enrolled.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
The main goals of the study are to assess benefits of higher doses of the nicotine patch prior to smoking cessation for high- and low-dependent smokers, and to investigate the potential relationship between genetic factors and smoking cessation success. There will be a two-week double-blind pre-cessation exposure to nicotine patch treatment in a sample of 240 high-dependent \& 240 low-dependent smokers; half of each group will wear two 21mg nicotine patches (42mg) daily, and half will wear one 21mg nicotine patch and one comparable placebo patch daily, resulting in the following four conditions (120 subjects each) during the 2-week pre-quit period: 1) Less Dependent/21mg nic., 2) Less Dependent/42mg nic., 3) More Dependent/21mg nic., and 4) More Dependent/42mg nic. After the quit date, subjects will continue with the same nicotine dosage for the 1st 4 weeks; after that the treatment will no longer be double-blind as only nicotine patches will be used: all subjects will wear one 21-mg patch daily for 2 weeks, one 14-mg patch daily for the following 2 weeks, and one 7-mg patch for the remaining 2 weeks. The four treatment groups will be distributed over 4 sites: Durham, Raleigh, Charlotte, and Winston-Salem. After the screening visit, subjects will have 7 lab visits: at 2 weeks, 1 week, and 1 day prior to the quit-smoking date, and at 1 week, 3 weeks, 6 weeks and 10 weeks after the quit-smoking date.
- Conditions
- Cigarette Smoking
- Being tested
- Nicotine Patch
- Keywords
- Cigarette, Nicotine
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine PatchDrug
Groups 1 \& 3 1-21mg Nicotine patch and 1-placebo for 2 wks pre quit day and 4 wks post quit day
Groups 2 \& 4 2-21mg Nicotine Patches for 2 wks pre quit day and 4 wks post quit day
| Study group | Role | What they receive |
|---|---|---|
| Less Dependent Smokers | Experimental | Not described Receives: Drug: Nicotine Patch |
| More Dependent Smokers | Experimental | Not described Receives: Drug: Nicotine Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Abstinence From Smoking at Ten Weeks Post-quit
Continuous abstinence from the target quit date through the end of treatment (10 weeks) was assessed based on self reports of continuous abstinence (i.e., no lapses) that were confirmed by end-expired CO levels ≤ 10 ppm.
Measured: May 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startAug 2007
- Primary completionMay 2009
- Study completionMay 2009
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 Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jed E Rose, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734617
- Sponsor's protocol ID
- Pro00001223
- Acronym
- CON NIC II
- Status last verified
- Feb 2011
- First submitted
- 13 Aug 2008
- Last updated
- 15 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Uhl GR, Drgon T, Johnson C, Ramoni MF, Behm FM, Rose JE. Genome-wide association for smoking cessation success in a trial of precessation nicotine replacement. Mol Med. 2010 Nov-Dec;16(11-12):513-26. doi: 10.2119/molmed.2010.00052. Epub 2010 Aug 24.
PubMed 20811658Rose JE, Behm FM, Drgon T, Johnson C, Uhl GR. Personalized smoking cessation: interactions between nicotine dose, dependence and quit-success genotype score. Mol Med. 2010 Jul-Aug;16(7-8):247-53. doi: 10.2119/molmed.2009.00159. Epub 2010 Mar 17.
PubMed 20379614
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Nicotine Patch / Denicotinized Cigarette Therapy for Smoking Cessation II
- ClinicalTrials.gov ID
- NCT00734617
- Acronym / sponsor ID
- CON NIC II / Pro00001223
- Conditions
- Cigarette Smoking
- Keywords
- Cigarette, Nicotine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Posted 1 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goals of the study are to assess benefits of higher doses of the nicotine patch prior to smoking cessation for high- and low-dependent smokers, and to investigate the potential relationship between genetic factors and smoking cessation success. There will be a two-week double-blind pre-cessation exposure to nicotine patch treatment in a sample of 240 high-dependent \& 240 low-dependent smokers; half of each group will wear two 21mg nicotine patches (42mg) daily, and half will wear one 21mg nicotine patch and one comparable placebo patch daily, resulting in the following four conditions (120 subjects each) during the 2-week pre-quit period: 1) Less Dependent/21mg nic., 2) Less Dependent/42mg nic., 3) More Dependent/21mg nic., and 4) More Dependent/42mg nic. After the quit date, subjects will continue with the same nicotine dosage for the 1st 4 weeks; after that the treatment will no longer be double-blind as only nicotine patches will be used: all subjects will wear one 21-mg patch daily for 2 weeks, one 14-mg patch daily for the following 2 weeks, and one 7-mg patch for the remaining 2 weeks. The four treatment groups will be distributed over 4 sites: Durham, Raleigh, Charlotte, and Winston-Salem. After the screening visit, subjects will have 7 lab visits: at 2 weeks, 1 week, and 1 day prior to the quit-smoking date, and at 1 week, 3 weeks, 6 weeks and 10 weeks after the quit-smoking date.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Less Dependent Smokers | Experimental | Drug: Nicotine Patch |
| More Dependent Smokers | Experimental | Drug: Nicotine Patch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects must be 18-65 years old, have smoked an average of at least 10 cigarettes per day for three cumulative or continuous years of a brand that delivers (by Federal Trade Commission rated yields) at least 0.5 mg nicotine, have an expired air carbon monoxide reading of at least 10 ppm, and express a desire to quit smoking. Additionally, subjects must express a willingness to switch to denicotinized cigarettes. A more dependent smoker is defined as someone with an FTND score of seven or greater. A less dependent smoker is defined as someone with an FTND score of less than seven.
Key exclusion criteria (3 listed)
- For those with a known history of hypertension, systolic >140 mm Hg, diastolic >100 mm Hg); hypotension (systolic <90 mm Hg, diastolic <60 mm Hg) Participants with hypertension or hypotension may, however, be allowed to participate in the study if the study physician or P.A. determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety. Subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100. Potential subjects who report coronary heart disease; heart attack; cardiac rhythm disorder (irregular heart rhythm); chest pains (unless history, exam, and EKG clearly indicate a non-cardiac source); cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure); history of skin allergy; active skin condition (psoriasis) within the last five years; skin disorder except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds.); liver or kidney disorder (except kidney stones, gallstones); gastrointestinal problems or disease other than gastroesophageal reflux or heartburn; ulcers; lung disorder (including but not limited to COPD, emphysema, and asthma); brain abnormality (including but not limited to, stroke, brain tumor, seizure disorder); history of fainting; problems giving blood samples; difficulty passing urine; diabetes treated with insulin, non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%); current cancer or treatment for cancer in the past 6 months(except basal or squamous cell skin cancer); other major medical condition; current psychiatric disease (with the exception of depression, anxiety disorders, OCD and ADHD) will be excluded from the study. Potential subjects who do not have a self reported diagnosis of the above listed conditions may be excluded if the study physician or P.A. determines that the history, physical findings, EKG, or laboratory studies reveal information that may jeopardize the subject's safe study participation.
- Potential subjects who have abused alcohol or drugs, or have used within the last 30 days experimental (investigational) drugs, psychiatric medications (including antidepressants, anti-psychotics) or any other medications that are known to affect smoking cessation (e.g. clonidine) will be excluded. Potential subjects who have used smokeless tobacco (chewing tobacco, snuff), cigars, pipes, nicotine replacement therapy, or other smoking cessation treatment within the last 2 weeks will be excluded. Pregnant or nursing mothers will be excluded.
- Use of non-opiate medications for pain or sleep will be allowed. For medical conditions that do not appear above, the study physician will be consulted and if the medical condition does not jeopardize safe study participation, then the subject may be enrolled.
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 PatchGroups 1 \& 3 1-21mg Nicotine patch and 1-placebo for 2 wks pre quit day and 4 wks post quit day Groups 2 \& 4 2-21mg Nicotine Patches for 2 wks pre quit day and 4 wks post quit day | Drug | Less Dependent Smokers, More Dependent Smokers |
Primary outcome
Continuous Abstinence From Smoking at Ten Weeks Post-quit
Time frame: May 2009
Continuous abstinence from the target quit date through the end of treatment (10 weeks) was assessed based on self reports of continuous abstinence (i.e., no lapses) that were confirmed by end-expired CO levels ≤ 10 ppm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20811658Uhl GR, Drgon T, Johnson C, Ramoni MF, Behm FM, Rose JE. Genome-wide association for smoking cessation success in a trial of precessation nicotine replacement. Mol Med. 2010 Nov-Dec;16(11-12):513-26. doi: 10.2119/molmed.2010.00052. Epub 2010 Aug 24.
- Derived from this study: PubMed 20379614Rose JE, Behm FM, Drgon T, Johnson C, Uhl GR. Personalized smoking cessation: interactions between nicotine dose, dependence and quit-success genotype score. Mol Med. 2010 Jul-Aug;16(7-8):247-53. doi: 10.2119/molmed.2009.00159. Epub 2010 Mar 17.
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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.
Jed E Rose, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nicotine Patch in people with Cigarette Smoking, run by Duke University 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 1 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 15 Jul 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 1 Mar 2011). 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?
Continuous Abstinence From Smoking at Ten Weeks Post-quit (time frame: May 2009). 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 NCT00734617, 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 15 Jul 2014; AzTrials last refreshed its copy on 31 Oct 2026.