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Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers (ConNic5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01806779
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : October 8, 2015
Last Update Posted : January 18, 2016
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Philip Morris USA, Inc.
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: Chantix Drug: Zyban Drug: Nicotine patches Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers
Study Start Date : March 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chantix
For 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.
Drug: Chantix
Other Name: Varenicline

Drug: Nicotine patches
All participants will receive 21 mg/24 h dose nicotine (nic.) patches for 1 week.
Other Name: NRT

Experimental: Chantix + Zyban
For 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.
Drug: Chantix
Other Name: Varenicline

Drug: Zyban
Other Name: Bupropion

Drug: Nicotine patches
All participants will receive 21 mg/24 h dose nicotine (nic.) patches for 1 week.
Other Name: NRT




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day [ Time Frame: 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.

  2. Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit [ Time Frame: Quit Day to 11-week post Quit Day study 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.


Other Outcome Measures:
  1. Change in Smoking Withdrawal Symptoms [ Time Frame: Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day ]
    Withdrawal symptoms will be assessed by questionnaire on Quit Day, Week 1, Week 3, Week 7 and Week 11 post target quit date and 6 months post quit Follow-Up (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
  • 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.

Exclusion Criteria:

  • 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);
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806779


Locations
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United States, North Carolina
Duke Center for Smoking Cessation
Charlotte, North Carolina, United States, 28210
Duke Center for Smoking Cessation
Durham, North Carolina, United States, 27705
Duke Center for Smoking Cessation
Raleigh, North Carolina, United States, 27609
Duke Center for Smoking Cessation
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Duke University
National Institute on Drug Abuse (NIDA)
Philip Morris USA, Inc.
Investigators
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Principal Investigator: Jed E Rose, Ph.D. Duke University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01806779    
Other Study ID Numbers: Pro00042699
1P50DA027840-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2013    Key Record Dates
Results First Posted: October 8, 2015
Last Update Posted: January 18, 2016
Last Verified: October 2015
Keywords provided by Duke University:
Nicotine addiction
Cigarette smoking
Smoking cessation
Zyban
Chantix
Nicotine patches
varenicline
bupropion
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors