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Nicotine DependencePhase 2ConNic5NCT01806779

Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers

A Phase 2 study testing Chantix, Zyban and Nicotine patches in people with Nicotine Dependence, run by Duke University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study. Read more about this study

Who is it for?
Ages 18 to 65 years, men only
Conditions the study is for
Nicotine Dependence
What is being tested?
Chantix, Zyban and Nicotine patches
Could I receive a placebo?
No, everyone receives an active treatment
How many people
376 participants
Where
4 sitesUnited States
Study dates
Mar 2013to Mar 2015
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 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have no known serious medical conditions;
  • Male;
  • Are 18-65 years old;
  • Smoke an average of at least 10 cigarettes per day;
  • Have smoked at least one cumulative year;
  • Have an expired air carbon monoxide (CO) reading of at least 10ppm;
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  • Able to read and understand English;
  • Express a desire to quit smoking in the next thirty days.
  • Potential subjects must agree to use acceptable contraception.
  • Potential subjects must agree to avoid the following:
  • participation in any other nicotine-related modification strategy outside of this protocol;
  • use of tobacco products other than cigarettes, including pipe tobacco, cigars, e-cigarettes, snuff, and chewing tobacco;
  • use of experimental (investigational) drugs or devices;
  • use of illegal drugs;
  • use of opiate medications.

Who cannot join

  • Hypertension;
  • Hypotension with symptoms;
  • Coronary heart disease;
  • Lifetime history of heart attack;
  • Cardiac rhythm disorder (irregular heart rhythm);
  • Chest pains (unless history, exam, and electrocardiogram (ECG) clearly indicate a non-cardiac source);
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  • Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
  • History of skin allergy;
  • Active skin disorder (e.g., psoriasis) within the last five years;
  • Liver or kidney disorder (except kidney stones, gallstones);
  • Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
  • Active ulcers in the past 30 days;
  • Currently symptomatic lung disorder/disease (including but not limited to Chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
  • Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
  • Migraine headaches that occur more frequently than once per week;
  • Recent, unexplained fainting spells;
  • Problems giving blood samples;
  • 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 six months (except basal or squamous cell skin cancer);
  • Other major medical condition;
  • Current psychiatric disease (with the exception of anxiety disorders, Obsessive Compulsive Disorder (OCD) and ADHD);
  • Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
  • Current depression;
  • Bulimia or anorexia;
  • Use of opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed) within the past 14 days;
  • Smoking more than one cigar a month.
  • Alcohol abuse;
  • Significant adverse reaction to nicotine patches, bupropion / Wellbutrin / Zyban or Chantix / varenicline in the past.
  • Current participation or recent participation (in the past 30 days) in another smoking study at our Center or another research facility.
  • Current participation in another research study.
  • Use (within the past 30 days) of:
  • Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates),
  • Experimental (investigational) drugs;
  • Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
  • Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;
  • Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine replacement therapy or any other smoking cessation aid.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Duke Center for Smoking Cessation

    Charlotte, North Carolina, 28210

  • Duke Center for Smoking Cessation

    Durham, North Carolina, 27705

  • Duke Center for Smoking Cessation

    Raleigh, North Carolina, 27609

  • Duke Center for Smoking Cessation

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study.

Being tested
Chantix, Zyban, Nicotine patches
Keywords
Nicotine addiction, Cigarette smoking, Smoking cessation, Zyban, Chantix, Nicotine patches, varenicline, bupropion
Medical subject headings
Tobacco Use Disorder, Cigarette Smoking, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChantixDrug

    Also called Varenicline

  • ZybanDrug

    Also called Bupropion

  • Nicotine patchesDrug

    Also called NRT

    All participants will receive 21 mg/24 h dose nicotine (nic.) patches for 1 week.

Study groups in NCT01806779
Study groupRoleWhat they receive
ChantixExperimentalFor the first 3 days after being switched from Nicotine Replacement Therapy (NRT) (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Receives: Drug: Chantix; Drug: Nicotine patches
Chantix + ZybanExperimentalFor the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Receives: Drug: Chantix; Drug: Zyban; Drug: Nicotine patches

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits

    This will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) <10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.

    Measured: Period between 8-week and 11-week visits post target Quit Day

Secondary outcomes (2)

  1. Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day

    This will be determined by a self-report of no smoking for the previous seven days when called for 6-month follow-up confirmed by expired air CO.

    Measured: 6 months post Quit Day

  2. Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit

    This will be determined by a composite of self-report of no smoking between study visits at the 1-week, 3-week, 7-week and 11-week post Quit Day study visits and expired air carbon monoxide (CO) <10 ppm (measured at those study visits). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.

    Measured: Quit Day to 11-week post Quit Day study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionDec 2014
  4. Study completionMar 2015

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
376 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01806779
Sponsor's protocol ID
Pro00042699
Other IDs
1P50DA027840-01A1
Acronym
ConNic5
Status last verified
Oct 2015
First submitted
6 Mar 2013
Last updated
18 Jan 2016
Data monitoring committee
Yes

Publications

  • Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

    PubMed 37142273

  • Rose JE, Behm FM. Combination Varenicline/Bupropion Treatment Benefits Highly Dependent Smokers in an Adaptive Smoking Cessation Paradigm. Nicotine Tob Res. 2017 Aug 1;19(8):999-1002. doi: 10.1093/ntr/ntw283.

    PubMed 29054128

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chantix, Zyban and Nicotine patches in people with Nicotine Dependence, run by Duke University at 4 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 15 inclusion and 36 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 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 8 Oct 2015). 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 Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (time frame: Period between 8-week and 11-week visits post target Quit Day). 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 NCT01806779, 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 Jan 2016.

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