Smoking CessationPhase 3ConNic3NCT00894166

Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype

A Phase 3 study testing Nicotine Patches, Nicotine patches, then bupropion & nicotine patches (Pre-Quit) and Nicotine patches, then varenicline (Pre-Quit) in people with Smoking Cessation, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Smoking Cessation
What is being tested?: Nicotine Patches, Nicotine patches, then bupropion & nicotine patches (Pre-Quit) and Nicotine patches, then varenicline (Pre-Quit)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 606 participants
Where: 1 siteUnited States
Study dates: May 2009to Oct 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18-65 years old
smoked an average of at least 10 cigarettes per day for three cumulative years of a brand that delivers (by Federal Trade Commission rated yields) at least 0.5mg nicotine
expired carbon monoxide reading of at least 15ppm
express a desire to quit smoking in the next 30 days

Who cannot join

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 (systolic <90 mm Hg, diastolic <60 mm Hg).
Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety.
Coronary heart disease;
Lifetime history of heart attack;
Cardiac rhythm disorder (irregular heart rhythm);

Show all 35Show fewer

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;
Lung disorder (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);
History of migraine headaches in the past 5 years;
History of fainting;
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 - The Patient Health Questionnaire (PHQ-9) for Depression will be used to screen for current (within 2 weeks) depression. Potential subjects who score >9 (or who score >0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") will be excluded from study participation, and, at the discretion of the study physician, referred to appropriate psychiatric treatment;
Bulimia or anorexia;
Pregnant or nursing mothers;
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);
Opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed)
Smokeless tobacco (chewing tobacco, snuff), cigars or pipes;
Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.
Alcohol abuse - The AUDIT (Alcohol Use Disorders Identification Test) questionnaire will be used to assess alcohol abuse. Potential participants will be asked the first two questions on the AUDIT questionnaire during the phone screen. If the person scores "4" on both questions, a screening appointment will not be scheduled. During the screening session the entire AUDIT questionnaire will be administered. Females who score greater than or equal to 13 and males who score greater than or equal to 15 will be excluded from the study.
Significant adverse reaction to Wellbutrin / Zyban or Chantix / Varenicline in the past

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke Center for Nicotine & Smoking Cessation Research
Charlotte, Durham, Raleigh, Winston-Salem, North Carolina

Other trials in United States

About this study

Nicotine replacement therapy (NRT) is a well-tolerated and efficacious smoking cessation treatment, and yet many smokers fail to quit using NRT. Many of these smokers may benefit from prescription treatment alternatives, including Zyban or Chantix. In this study, the investigators propose to develop and evaluate a stepped-care treatment algorithm that would evaluate whether smokers who receive treatment with NRT should be supplemented with Zyban or switched to Chantix only based on: 1) their initial response to NRT; and 2) individual genetic factors found to predict smoking cessation in other studies evaluating these treatments. This study is a continuation of our previous studies showing that abstinence rates can be increased by starting nicotine patch therapy two weeks before the quit date. The investigators will provide pre-cessation NRT to all participants initially. Those who do not show a favorable response on early indicators of success (e.g., smoking in the first week after the target quit-smoking date) will receive "rescue" treatment by having their NRT treatment supplemented with Zyban , by being switched to treatment with Chantix or will remain on NRT (control).

The investigators hypothesize that "Rescue" treatment with Zyban in combination with NRT or Chantix will increase success rates over leaving subjects on NRT when they are NRT insufficient responders, i.e. they have shown an unfavorable response to NRT in the first week pre-quit or the first week post-quit.

Conditions: Smoking Cessation
Being tested: Nicotine Patches, Nicotine patches, then bupropion & nicotine patches (Pre-Quit), Nicotine patches, then varenicline (Pre-Quit), Nicotine patches, then nicotine patches (Pre-Quit), Nicotine patches, then bupropion & nicotine patches (Post-Quit)
Keywords: Smoking Cessation, Chantix, varenicline, Nicotine Replacement Therapy, Nicotine Patches, Zyban, bupropion, Quit Smoking
Medical subject headings: Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nicotine PatchesDrug
Also called NicoDermCQ
21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.
Nicotine patches, then bupropion & nicotine patches (Pre-Quit)Drug
Also called Zyban, NicoDermCQ
21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.
Nicotine patches, then varenicline (Pre-Quit)Drug
Also called Chantix, NicoDermCQ
21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)
Nicotine patches, then nicotine patches (Pre-Quit)Drug
Also called NicoDermCQ
21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.
Nicotine patches, then bupropion & nicotine patches (Post-Quit)Drug
Also called Zyban, NicoDermCQ
21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.
Nicotine patches, then varenicline (Post-Quit)Drug
Also called Chantix, NicoDermCQ
21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)
Nicotine patches, then nicotine patches (Post-Quit)Drug
Also called NicoDermCQ
21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.

Study groups in NCT00894166
Study group	Role	What they receive
Nicotine Replacement Therapy Responder	Active comparator	Nicotine Responders Receives: Drug: Nicotine Patches
Pre-Quit Rescue to Bupropion & Nicotine	Active comparator	Participants not responsive to nicotine patches who are randomly assigned at week 2 to use of Zyban (bupropion) in combination with nicotine patches Receives: Drug: Nicotine patches, then bupropion & nicotine patches (Pre-Quit)
Pre-Quit Rescue to Varenicline	Active comparator	Participants not responsive to nicotine patches who are randomly assigned at week 2 to use of Chantix (varenicline) Receives: Drug: Nicotine patches, then varenicline (Pre-Quit)
Pre-Quit Rescue to Nicotine	Active comparator	Participants not responsive to nicotine patches who are randomly assigned at week 2 to continued use of nicotine patches Receives: Drug: Nicotine patches, then nicotine patches (Pre-Quit)
Post-Quit Rescue to Bupropion & Nicotine	Active comparator	Participants not responsive to nicotine patches who are randomly assigned at week 4 to use of Zyban (bupropion) in combination with nicotine patches Receives: Drug: Nicotine patches, then bupropion & nicotine patches (Post-Quit)
Post-Quit Rescue to Varenicline	Active comparator	Participants not responsive to nicotine patches who are randomly assigned at week 4 to use of Chantix (varenicline) Receives: Drug: Nicotine patches, then varenicline (Post-Quit)
Post-Quit Rescue to Nicotine	Active comparator	Participants not responsive to nicotine patches who are randomly assigned at week 4 to continued use of nicotine patches Receives: Drug: Nicotine patches, then nicotine patches (Post-Quit)

What is being measured

The primary outcome is the main question the study is designed to answer.

Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment)
A self report of no cigarettes smoked confirmed by expired air carbon monoxide of <=10ppm was the criterion for abstinence.
Measured: weeks 8-11 after quit date

Secondary outcomes (2)

Abstinence (7 Days) at 6 Months.
Measured: point abstinence (7 days) at 6 months post-quit date
Continuous Abstinence From Smoking at 6 Months Post Quit.
Measured: continuous abstinence at 6 months post quit day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Oct 2011

First posted6 May 2009 (estimated)
Study startMay 2009
Primary completionJul 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Smoking CessationStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 606 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00894166
Sponsor's protocol ID: Pro00013846
Acronym: ConNic3
Status last verified: Sep 2013
First submitted: 4 May 2009
Last updated: 23 Sep 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
PubMed 37230961
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.
PubMed 37142273
Rose JE, Behm FM. Adapting smoking cessation treatment according to initial response to precessation nicotine patch. Am J Psychiatry. 2013 Aug;170(8):860-7. doi: 10.1176/appi.ajp.2013.12070919.
PubMed 23640009
Uhl GR, Walther D, Musci R, Fisher C, Anthony JC, Storr CL, Behm FM, Eaton WW, Ialongo N, Rose JE. Smoking quit success genotype score predicts quit success and distinct patterns of developmental involvement with common addictive substances. Mol Psychiatry. 2014 Jan;19(1):50-4. doi: 10.1038/mp.2012.155. Epub 2012 Nov 6.
PubMed 23128154

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype
ClinicalTrials.gov ID: NCT00894166
Acronym / sponsor ID: ConNic3 / Pro00013846
Conditions: Smoking Cessation
Keywords: Smoking Cessation, Chantix, varenicline, Nicotine Replacement Therapy, Nicotine Patches, Zyban, bupropion, Quit Smoking
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 606 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Philip Morris USA, Inc.
Study start: May 2009
Primary completion: Jul 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 6 May 2009 (estimated)
Results: Posted 26 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 7

Arm	Type	Receives
Nicotine Replacement Therapy Responder	Active comparator	Drug: Nicotine PatchesNicotine Responders
Pre-Quit Rescue to Bupropion & Nicotine	Active comparator	Drug: Nicotine patches, then bupropion & nicotine patches (Pre-Quit)Participants not responsive to nicotine patches who are randomly assigned at week 2 to use of Zyban (bupropion) in combination with nicotine patches
Pre-Quit Rescue to Varenicline	Active comparator	Drug: Nicotine patches, then varenicline (Pre-Quit)Participants not responsive to nicotine patches who are randomly assigned at week 2 to use of Chantix (varenicline)
Pre-Quit Rescue to Nicotine	Active comparator	Drug: Nicotine patches, then nicotine patches (Pre-Quit)Participants not responsive to nicotine patches who are randomly assigned at week 2 to continued use of nicotine patches
Post-Quit Rescue to Bupropion & Nicotine	Active comparator	Drug: Nicotine patches, then bupropion & nicotine patches (Post-Quit)Participants not responsive to nicotine patches who are randomly assigned at week 4 to use of Zyban (bupropion) in combination with nicotine patches
Post-Quit Rescue to Varenicline	Active comparator	Drug: Nicotine patches, then varenicline (Post-Quit)Participants not responsive to nicotine patches who are randomly assigned at week 4 to use of Chantix (varenicline)
Post-Quit Rescue to Nicotine	Active comparator	Drug: Nicotine patches, then nicotine patches (Post-Quit)Participants not responsive to nicotine patches who are randomly assigned at week 4 to continued use of nicotine patches

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

18-65 years old
smoked an average of at least 10 cigarettes per day for three cumulative years of a brand that delivers (by Federal Trade Commission rated yields) at least 0.5mg nicotine
expired carbon monoxide reading of at least 15ppm
express a desire to quit smoking in the next 30 days

Key exclusion criteria (35 listed)

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 (systolic <90 mm Hg, diastolic <60 mm Hg).
Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety.
Coronary heart disease;
Lifetime history of heart attack;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nicotine PatchesAlso: NicoDermCQ21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.	Drug	Nicotine Replacement Therapy Responder
Nicotine patches, then bupropion & nicotine patches (Pre-Quit)Also: Zyban, NicoDermCQ21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.	Drug	Pre-Quit Rescue to Bupropion & Nicotine
Nicotine patches, then varenicline (Pre-Quit)Also: Chantix, NicoDermCQ21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)	Drug	Pre-Quit Rescue to Varenicline
Nicotine patches, then nicotine patches (Pre-Quit)Also: NicoDermCQ21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.	Drug	Pre-Quit Rescue to Nicotine
Nicotine patches, then bupropion & nicotine patches (Post-Quit)Also: Zyban, NicoDermCQ21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.	Drug	Post-Quit Rescue to Bupropion & Nicotine
Nicotine patches, then varenicline (Post-Quit)Also: Chantix, NicoDermCQ21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)	Drug	Post-Quit Rescue to Varenicline
Nicotine patches, then nicotine patches (Post-Quit)Also: NicoDermCQ21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.	Drug	Post-Quit Rescue to Nicotine

Primary outcome

Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment)
Time frame: weeks 8-11 after quit date
A self report of no cigarettes smoked confirmed by expired air carbon monoxide of <=10ppm was the criterion for abstinence.

2 secondary outcomes

Abstinence (7 Days) at 6 Months.
Time frame: point abstinence (7 days) at 6 months post-quit date
Continuous Abstinence From Smoking at 6 Months Post Quit.
Time frame: continuous abstinence at 6 months post quit day

Results and safety

Results posted to the registry on 26 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NRT Responder	132	71
Pre-Quit Randomization to Bupropion + NRT	109	46
Pre-Quit Randomization to Varenicline	112	50
Pre-Quit Randomization to NRT	114	45
Post-Quit Randomization to Bupropion + NRT	34	10
Post-Quit Randomized to Varenicline	36	20
Post-Quit Randomized to NRT	35	19
Withdrew Prior to Randomization	34	0

Primary outcome: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment)

Time frame: weeks 8-11 after quit date. Number (95% Confidence Interval). Unit: percentage of subjects abstinent

Measure	NRT Responder n = 120	Pre-Quit Randomization to Bupropion + NRT n = 99	Pre-Quit Randomization to Varenicline n = 103	Pre-Quit Randomization to NRT n = 106	Post-Quit Randomization to Bupropion + NRT n = 30	Post-Quit Randomized to Varenicline n = 35	Post-Quit Randomized to NRT n = 30
Value	59.2 (50.4 to 68)	28.3 (19.4 to 37.2)	23.3 (15.1 to 31.5)	16.0 (9 to 23)	26.7 (10.9 to 42.5)	37.1 (21.1 to 53.1)	26.7 (10.9 to 42.5)

Population analysed: All participants were included in the analyses except those dropping out prior to randomization points, those censored for taking contraindicated medications or failing to meet other inclusion criteria, and one death having no apparent relationship to treatment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subjects were receiving study drugs for 11-13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NRT Responder	3 of 132 (2.3%)	88 of 132 (66.7%)	Not reported
Pre-Quit Randomization to Bupropion + NRT	4 of 109 (3.7%)	74 of 109 (67.9%)	Not reported
Pre-Quit Randomization to Varenicline	3 of 112 (2.7%)	64 of 112 (57.1%)	Not reported
Pre-Quit Randomization to NRT	2 of 114 (1.8%)	85 of 114 (74.6%)	Not reported
Post-Quit Randomization to Bupropion + NRT	2 of 34 (5.9%)	31 of 34 (91.2%)	Not reported
Post-Quit Randomized to Varenicline	1 of 36 (2.8%)	27 of 36 (75%)	Not reported
Post-Quit Randomized to NRT	1 of 35 (2.9%)	28 of 35 (80%)	Not reported

Limitations and caveats (from the sponsor): The group sizes for the post quit date randomization groups was relatively small. Second, the study used a tailored dose of pre-cessation nicotine patch therapy that is not in accordance with current product labeling in the US.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37230961Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
Derived from this study: PubMed 37142273Livingstone-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.
Derived from this study: PubMed 23640009Rose JE, Behm FM. Adapting smoking cessation treatment according to initial response to precessation nicotine patch. Am J Psychiatry. 2013 Aug;170(8):860-7. doi: 10.1176/appi.ajp.2013.12070919.
Derived from this study: PubMed 23128154Uhl GR, Walther D, Musci R, Fisher C, Anthony JC, Storr CL, Behm FM, Eaton WW, Ialongo N, Rose JE. Smoking quit success genotype score predicts quit success and distinct patterns of developmental involvement with common addictive substances. Mol Psychiatry. 2014 Jan;19(1):50-4. doi: 10.1038/mp.2012.155. Epub 2012 Nov 6.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jed E Rose, Ph.D. principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (time frame: weeks 8-11 after quit date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00894166, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2013.