Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers

NCT01806779 | Completed Phase 2 Results DMC

• 2 other identifiers: Pro000426991P50DA027840-01A1
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 4

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.

Conditions

Nicotine Dependence

Keywords

Nicotine addiction; Cigarette smoking; Smoking cessation; Zyban; Chantix; Nicotine patches; varenicline; bupropion

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

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

  6 months post Quit Day

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

  Quit Day to 11-week post Quit Day study visit

Other Outcomes (1)

• Change in Smoking Withdrawal Symptoms

  Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day

Study Arms (2)

Chantix

EXPERIMENTAL

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; Drug: Nicotine patches

Chantix + Zyban

EXPERIMENTAL

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; Drug: Zyban; Drug: Nicotine patches

Interventions

Chantix DRUG

Also known as: Varenicline

Chantix; Chantix + Zyban

Zyban DRUG

Also known as: Bupropion

Chantix + Zyban

Nicotine patches DRUG

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

Also known as: NRT

Chantix; Chantix + Zyban

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Duke University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Philip Morris USA, Inc.: collaborator

Study Sites (4)

Duke Center for Smoking Cessation

Charlotte, North Carolina, 28210, United States

Location

Duke Center for Smoking Cessation

Durham, North Carolina, 27705, United States

Location

Duke Center for Smoking Cessation

Raleigh, North Carolina, 27609, United States

Location

Duke Center for Smoking Cessation

Winston-Salem, North Carolina, 27103, United States

Location

Related Publications (2)

• 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.

  PMID: 37142273 DERIVED

• 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.

  PMID: 29054128 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Cigarette Smoking; Smoking Cessation

Interventions

Varenicline; Bupropion; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Propiophenones; Ketones; Organic Chemicals; Therapeutics

Results Point of Contact

• Title: Dr. Jed E. Rose
• Organization: Duke Center for Smoking Cessation

jed.rose@duke.edu

919-668-5055

Study Officials

• Jed E Rose, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 7, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: January 18, 2016
• Results First Posted: October 8, 2015

Record last verified: 2015-10

Locations

US (4)