Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers

Nicotine Dependence Clinical Trial

— ConNic5  

Official title:

Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806779
• Other study ID #: Pro00042699
• Secondary ID: 1P50DA027840-01A
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2013
• Last updated: December 14, 2015
• Start date: March 2013
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

Drug:
• Chantix

• Zyban

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

Locations

Country	Name	City	State
United States	Duke Center for Smoking Cessation	Charlotte	North Carolina
United States	Duke Center for Smoking Cessation	Durham	North Carolina
United States	Duke Center for Smoking Cessation	Raleigh	North Carolina
United States	Duke Center for Smoking Cessation	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute on Drug Abuse (NIDA), Philip Morris USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Smoking Withdrawal Symptoms	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.	Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day	No
Primary	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.	Period between 8-week and 11-week visits post target Quit Day	No
Secondary	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.	6 months post Quit Day	No
Secondary	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.	Quit Day to 11-week post Quit Day study visit	No