- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01303861
Concurrent Bupropion / Varenicline for Smoking Cessation (ConNic4)
August 4, 2014 updated by: Duke University
This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient.
These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion.
Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies.
The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
702
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Charlotte, North Carolina, United States, 28210
- Duke Center for Nicotine and Smoking Cessation Research
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Durham, North Carolina, United States, 27705
- Duke Center for Nicotine and Smoking Cessation Research
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Raleigh, North Carolina, United States, 27609
- Duke Center for Nicotine and Smoking Cessation Research
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Winston-Salem, North Carolina, United States, 27103
- Duke Center for Nicotine and Smoking Cessation Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-65 years old;
- smoked an average of at least 10 cigarettes per day for three cumulative years;
- have an expired air CO reading assessed at screening of at least 10ppm;
- express a desire to quit smoking within the next 30 days.
Exclusion Criteria:
- Hypertension (systolic >140 mm Hg, diastolic >100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
- Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg).
- Coronary heart disease;
- Lifetime history of heart attack;
- Cardiac rhythm disorder (irregular heart rhythm);
- Chest pains (unless history, exam, and ECG 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 disorder (e.g., psoriasis) within the last five years, 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;
- 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;
- Pregnant or nursing mothers;
- Alcohol abuse;
- Use of Opiate medications for pain or sleep in the past 14 days;
- Significant adverse reaction to nicotine patches, nicotine inhalers, bupropion / Wellbutrin / Zyban or Chantix / Varenicline in the past.
- Use (within the past 30 days) of:
- Illegal drugs (or if the urine drug screen is positive),
- 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), cigars, pipes or e-cigarettes;
- Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: varenicline
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2).
They will receive varenicline.
|
For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
Other Names:
|
ACTIVE_COMPARATOR: Nicotine Patches only
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2).
They will continue to receive only nicotine patches.
|
Nicotine Replacement Therapy Groups:
Varenicline and varenicline in combination with bupropion groups:
Other Names:
|
ACTIVE_COMPARATOR: Nicotine Patches with Nicotine Inhaler
This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2).
They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.
|
Nicotine Replacement Therapy Groups:
Varenicline and varenicline in combination with bupropion groups:
Other Names:
Nicotine inhaler to use as needed after quit date
Other Names:
|
ACTIVE_COMPARATOR: varenicline with bupropion
This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2).
They will receive varenicline in combination with bupropion.
|
For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.
Other Names:
For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day.
Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Four-week Continuous Abstinence From Cigarette Smoking
Time Frame: Study week 8 thru week 11
|
The primary dependent measures will be continuous four-week abstinence from weeks 8-11 post target quit date, defined as a self-report of no smoking confirmed by expired air carbon monoxide.
|
Study week 8 thru week 11
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seven Day Point Abstinence From Cigarette Smoking
Time Frame: Six months post quit date
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Secondary outcome will include point abstinence (no smoking in the previous 7-day) at 6 months post-quit.
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Six months post quit date
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Continuous Cigarette Abstinence From Quit Date
Time Frame: From Quit date to end of treatment (week 11)
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Secondary outcome will include continuous abstinence from quit date to end of treatment (week 11).
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From Quit date to end of treatment (week 11)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
- Rose JE, Behm FM. Combination treatment with varenicline and bupropion in an adaptive smoking cessation paradigm. Am J Psychiatry. 2014 Nov 1;171(11):1199-205. doi: 10.1176/appi.ajp.2014.13050595.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
July 1, 2013
Study Registration Dates
First Submitted
February 23, 2011
First Submitted That Met QC Criteria
February 23, 2011
First Posted (ESTIMATE)
February 25, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
August 6, 2014
Last Update Submitted That Met QC Criteria
August 4, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Nicotine
- Bupropion
- Varenicline
Other Study ID Numbers
- Pro00027351
- 1P50DA027840-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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