NCT01303861

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
702

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 1, 2014

Completed
Last Updated

August 6, 2014

Status Verified

May 1, 2014

Enrollment Period

2 years

First QC Date

February 23, 2011

Results QC Date

July 5, 2014

Last Update Submit

August 4, 2014

Conditions

Nicotine Dependence

Keywords

Nicotine addictionCigarette smokingSmoking cessationZybanChantixNicotine patchesNicotrol Inhalervareniclinebupropion

Outcome Measures

Primary Outcomes (1)

  • 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.

    Study week 8 thru week 11

Secondary Outcomes (2)

  • Seven Day Point Abstinence From Cigarette Smoking

    Six months post quit date

  • Continuous Cigarette Abstinence From Quit Date

    From Quit date to end of treatment (week 11)

Study Arms (4)

varenicline

ACTIVE COMPARATOR

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.

Drug: Varenicline

Nicotine Patches only

ACTIVE COMPARATOR

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.

Drug: Nicotine patches

Nicotine Patches with Nicotine Inhaler

ACTIVE COMPARATOR

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.

Drug: Nicotine patchesDrug: Nicotine Inhaler

varenicline with bupropion

ACTIVE COMPARATOR

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.

Drug: VareniclineDrug: Bupropion

Interventions

VareniclineDRUG

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.

Also known as: Chantix
vareniclinevarenicline with bupropion
BupropionDRUG

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.

Also known as: Zyban
varenicline with bupropion
Nicotine patchesDRUG

Nicotine Replacement Therapy Groups: 1. 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 2. 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: 1. For smokers with high baseline CO: 42 mg/24 h for 1 week 2. For smokers with low baseline CO: 21 mg/24 h for 1 week

Also known as: Nicoderm
Nicotine Patches onlyNicotine Patches with Nicotine Inhaler
Nicotine InhalerDRUG

Nicotine inhaler to use as needed after quit date

Also known as: Nicotrol Inhaler
Nicotine Patches with Nicotine Inhaler

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Duke Center for Nicotine and Smoking Cessation Research

Charlotte, North Carolina, 28210, United States

Location

Duke Center for Nicotine and Smoking Cessation Research

Durham, North Carolina, 27705, United States

Location

Duke Center for Nicotine and Smoking Cessation Research

Raleigh, North Carolina, 27609, United States

Location

Duke Center for Nicotine and Smoking Cessation Research

Winston-Salem, North Carolina, 27103, United States

Location

Related Publications (3)

  • 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: 37142273DERIVED

  • 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.

    PMID: 34611902DERIVED

  • 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.

    PMID: 24934962DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderCigarette SmokingSmoking Cessation

Interventions

VareniclineBupropionTobacco Use Cessation DevicesNicotine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersTobacco SmokingSmokingBehaviorTobacco UseHealth Behavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalinesPropiophenonesKetonesOrganic ChemicalsTherapeuticsSolanaceous AlkaloidsAlkaloidsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Dr. Jed E. Rose
Organization
Duke University Medical Center - Duke Center for Smoking Cessation
jed.rose@dm.duke.edu
919-668-5055

Study Officials

  • Jed E Rose, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
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

February 23, 2011

First Posted

February 25, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2013

Study Completion

July 1, 2013

Last Updated

August 6, 2014

Results First Posted

August 1, 2014

Record last verified: 2014-05

Locations

US(4)