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Concurrent Bupropion / Varenicline for Smoking Cessation (ConNic4)

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Varenicline
Bupropion
Nicotine patches
Nicotine Inhaler
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Nicotine addiction, Cigarette smoking, Smoking cessation, Zyban, Chantix, Nicotine patches, Nicotrol Inhaler, varenicline, bupropion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke Center for Nicotine and Smoking Cessation Research
  • Duke Center for Nicotine and Smoking Cessation Research
  • Duke Center for Nicotine and Smoking Cessation Research
  • Duke Center for Nicotine and Smoking Cessation Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

varenicline

Nicotine Patches only

Nicotine Patches with Nicotine Inhaler

varenicline with bupropion

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Four-week Continuous Abstinence From Cigarette Smoking
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.

Secondary Outcome Measures

Seven Day Point Abstinence From Cigarette Smoking
Secondary outcome will include point abstinence (no smoking in the previous 7-day) at 6 months post-quit.
Continuous Cigarette Abstinence From Quit Date
Secondary outcome will include continuous abstinence from quit date to end of treatment (week 11).

Full Information

First Posted
February 23, 2011
Last Updated
August 4, 2014
Sponsor
Duke University
Collaborators
National Institute on Drug Abuse (NIDA), Philip Morris USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01303861
Brief Title
Concurrent Bupropion / Varenicline for Smoking Cessation
Acronym
ConNic4
Official Title
Concurrent Bupropion / Varenicline for Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute on Drug Abuse (NIDA), Philip Morris USA, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
Nicotine addiction, Cigarette smoking, Smoking cessation, Zyban, Chantix, Nicotine patches, Nicotrol Inhaler, varenicline, bupropion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
702 (Actual)

8. Arms, Groups, and Interventions

Arm Title
varenicline
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Nicotine Patches only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Nicotine Patches with Nicotine Inhaler
Arm Type
Active Comparator
Arm Description
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.
Arm Title
varenicline with bupropion
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
Zyban
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nicotine patches
Other Intervention Name(s)
Nicoderm
Intervention Description
Nicotine Replacement Therapy Groups: For smokers with high baseline carbon monoxide (CO): 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. Varenicline and varenicline in combination with bupropion groups: For smokers with high baseline CO: 42 mg/24 h for 1 week For smokers with low baseline CO: 21 mg/24 h for 1 week
Intervention Type
Drug
Intervention Name(s)
Nicotine Inhaler
Other Intervention Name(s)
Nicotrol Inhaler
Intervention Description
Nicotine inhaler to use as needed after quit date
Primary Outcome Measure Information:
Title
Four-week Continuous Abstinence From Cigarette Smoking
Description
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.
Time Frame
Study week 8 thru week 11
Secondary Outcome Measure Information:
Title
Seven Day Point Abstinence From Cigarette Smoking
Description
Secondary outcome will include point abstinence (no smoking in the previous 7-day) at 6 months post-quit.
Time Frame
Six months post quit date
Title
Continuous Cigarette Abstinence From Quit Date
Description
Secondary outcome will include continuous abstinence from quit date to end of treatment (week 11).
Time Frame
From Quit date to end of treatment (week 11)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jed E Rose, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Center for Nicotine and Smoking Cessation Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Duke Center for Nicotine and Smoking Cessation Research
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Center for Nicotine and Smoking Cessation Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Duke Center for Nicotine and Smoking Cessation Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34611902
Citation
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.
Results Reference
derived
PubMed Identifier
24934962
Citation
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.
Results Reference
derived

Learn more about this trial

Concurrent Bupropion / Varenicline for Smoking Cessation

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