Tobacco DependencePhase 2NCT01444131
Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
A Phase 2 study testing Varenicline, Nicotine Patch in people with Tobacco Dependence, run by University of Stellenbosch at 7 sites in South Africa.
Trial summary
The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Varenicline, Nicotine Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 446 participants
- Where
- 7 sitesSouth Africa
- Study dates
- Apr 2011to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current cigarette smokers, male and female, aged between 18-75 years (both limits inclusive), and who are motivated to stop smoking.
- Have smoked on average at least 10 cigarettes per day during past year and during the month prior to screening, and no period of abstinence greater than 3 months in the past year.
- Women of child-bearing potential (WCBP) may be included provided they are not pregnant, not nursing, and meet all of the following criteria:
- instructed and agree to avoid pregnancy through 30 days after the last dose of study medication
- negative screening test (beta-HCG) at screening
- agree to use at least one birth control method (oral contraceptive, IUD, implantable or injectable contraceptive for at least 1 month prior to entering the study and will continue its use through at least 30 days after the last dose of study medication, or use a barrier method of contraception (p.e.condom, diaphragm with spermicide) while participating in the study through at least 30 days after the last dose of study medication; or abstinence.
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- Patients must have no serious or unstable disease in the past 6 months.
- Patients must be able to be outpatients, to be assessed in a clinical setting, and be able and willing to comply with all study visits during the treatment and non-treatment periods.
- Only one subject per household may participate.
Who cannot join
- Patients currently suffering from depression or who have been diagnosed with depression or treated with anti-depressants within the past 12 months.
- Patients with a past of present history of psychosis, panic disorder, or bipolar disorder.
- Patients with severe chronic obstructive pulmonary disease (COPD).
- Patients with clinically significant cardiovascular disease in the past 6 months. such as myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), severe or unstable angina, serious arrhythmia, and clinically significant ECG conduction abnormalities.
- Patients with uncontrolled hypertension or a systolic blood pressure greater than 150mmHg or as diastolic pressure greater than 95mmHg at screening or baseline.
- Patients with clinically significant neurological disorders or cerebrovascular diseases (for example, stroke, transient ischemic attack, etc.) in the past 6 months.
Show all 20Show fewer
- Patients with a history of clinically significant endocrine disorders or gastrointestinal diseases, including insulin dependent diabetes mellitus, uncontrolled hyperthyroidism, and active peptic ulcer.
- Patients with clinically significant hepatic or renal impairment or other clinically significant abnormal laboratory test values.
- Patients with a history of cancer (cured basal cell or squamous cell carcinoma of the skin allowed).
- Patients with a history of clinically significant allergic reactions to drugs (for example, severe cutaneous and/or systemic allergic reactions).
- Patients with a history of drug (except nicotine) or alcohol abuse or dependence within the past 12 months.
- Patients with a body mass index (BMI) less than 15 or greater than 38 when wearing indoor clothing without shoes. No subject will be enrolled with a weight less than 45.5kg (100 pounds).
- Patients previously enrolled in a study that included varenicline.
- Patients having used nicotine replacement therapy within the last 6 months.
- Patients taking another investigational drug within 30 days or 5 half-lives (whichever is longer) before the Baseline visit or within 30 days of study completion.
- Use of prohibited medications: any antidepressants, including bupropion; antipsychotic agents; mood stabilizers; naltrexone; steroids (inhaled and topical steroids are permitted); insulin.
- Patients who do not agree to completely abstain from using non-cigarette tobacco products (including for example, pipe tobacco, cigars, snuff, chewing tobacco, etc.) or marijuana during study participation.
- Patients who intend to donate blood or blood components while receiving study drug or within 1 month of the completion of the study treatment.
- Patients unable/or unlikely to comprehend and follow the study protocol, including patients unable and/or unwilling to participate in the non-treatment follow-up. Patients who, in the investigator's opinion, will be unlikely to commit to a 6 month-long study.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Africa7 sites
Respiratory Research Unit
Cape Town, Western Cape, 7505
Synopsis Research
Cape Town, Western Cape, 7700
UCT Lung Institute
Cape Town, Western Cape, 8000
Dr JA O'Brien
Cape Town, Western Cape, 8001
Dr MS Abdool-Gaffar
eManzimtoti, 4126
Dr AHH Brüning
Gatesville / Cape Town, Western Cape, 7764
Dr C Smith
Sandton, 2010
About this study
Official title: A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe.
Read the detailed description
This is a phase-II multicenter study involving 438 smokers, to be conducted at 7 sites in South Africa, over 6 months. In a randomized 1:1 allocation varenicline tartrate 1 mg twice daily, given in an incremental dosage for the first week before target quit date (TQD), will be compared to varenicline tartrate in the same dose combined with a 15mg nicotine patch. The nicotine patch (active and placebo) will be provided by McNeil. The patch will be given 2 weeks prior TQD. Treatment duration from TQD is 12 weeks with varenicline being tapered off during week 13.
A total of 12 clinic visits and 1 telephonic contact is planned for the 6-month study duration. The main efficacy outcome will be the 4-week continuous abstinence rate during the last four weeks of treatment, i.e. weeks 9 - 12. Efficacy assessments will be based on a Nicotine Use Inventory and measurements of end-expiratory exhaled carbon monoxide. Safety assessments will be based on adverse events evaluation, with special attention being given to the occurrence of nausea during the pretreatment period, as well as neuro-psychiatric symptoms such as depression or suicidal ideation. Participants will not be subjected to any invasive procedures.
This protocol is based on current evidence and two further abstracts presented at the European Respiratory Society Conference in Vienna, September 2009, that a combination of varenicline tartrate and nicotine replacement therapy indicate superior efficacy in cessation rate, but also an excellent good safety profile.
This study relates to the area of pharmacotherapy of smoking cessation, and will answer a frequently asked question. Importantly, several leading pulmonologists with experience in smoking cessation in South Africa have expressed their keen interest to participate in this study.
- Conditions
- Tobacco Dependence
- Being tested
- Varenicline, Nicotine Patch, Varenicline and Placebo Patch
- Keywords
- Smoking, Smoking cessation, Pharmaceutical aids
- Medical subject headings
- Tobacco Use Disorder, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varenicline, Nicotine PatchDrug
Also called Champix, Nicorette
active nicotine patches added to varenicline.
Varenicline and Placebo PatchDrug
placebo nicotine patches added to varenicline.
| Study group | Role | What they receive |
|---|---|---|
| Varenicline and Placebo Patch | Placebo comparator | Varenicline and Nicotine Patch (placebo) Receives: Drug: Varenicline and Placebo Patch |
| Varenicline and Nicotine Patch | Active comparator | Varenicline and Nicotine Patch 15mg Receives: Drug: Varenicline, Nicotine Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
continuous abstinence (CAR) from weeks 9 to 12 of treatment
The primary endpoint is the 4-week continuous abstincence rate for week 9 - 12 of treatment, i.e. the proportion of patients who are able to maintain complete abstinence from cigarette smoking and other nicotine use, with end-expiratory exhaled carbon monoxide (CO) measurements 10 ppm or less, for the planned last 4 weeks of treatment.
Measured: 3 months
Secondary outcomes (1)
CAR from weeks 9 to 24
The secondary endpoint is the 4-week continuous abstincence rate for week 9 - 24 of treatment, i.e. the proportion of patients who are able to maintain complete abstinence from cigarette smoking and other nicotine use, with end-expiratory exhaled carbon monoxide (CO) measurements 10 ppm or less, for the planned last 4 weeks of treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stellenbosch
- Sponsor type
- University, hospital or other
- Collaborators
- QuitSupport
- Responsible party
- Principal investigator, Prof Elvis M Irusen, University of Stellenbosch
- Investigators
- Elvis M Irusen, MBChB, FCP, PhD, Principal investigator, University of Stellenbosch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444131
- Sponsor's protocol ID
- VarNic
- Status last verified
- Mar 2014
- First submitted
- 27 Sep 2011
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR; Varenicline Phase 3 Study Group. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):47-55. doi: 10.1001/jama.296.1.47.
PubMed 16820546Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR; Varenicline Phase 3 Study Group. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):56-63. doi: 10.1001/jama.296.1.56.
PubMed 16820547Tonstad S, Tonnesen P, Hajek P, Williams KE, Billing CB, Reeves KR; Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):64-71. doi: 10.1001/jama.296.1.64.
PubMed 16820548Tonnesen P, Paoletti P, Gustavsson G, Russell MA, Saracci R, Gulsvik A, Rijcken B, Sawe U. Higher dosage nicotine patches increase one-year smoking cessation rates: results from the European CEASE trial. Collaborative European Anti-Smoking Evaluation. European Respiratory Society. Eur Respir J. 1999 Feb;13(2):238-46. doi: 10.1034/j.1399-3003.1999.13b04.x.
PubMed 10065662Schuurmans MM, Diacon AH, van Biljon X, Bolliger CT. Effect of pre-treatment with nicotine patch on withdrawal symptoms and abstinence rates in smokers subsequently quitting with the nicotine patch: a randomized controlled trial. Addiction. 2004 May;99(5):634-40. doi: 10.1111/j.1360-0443.2004.00711.x.
PubMed 15078238Shiffman S, Ferguson SG. Nicotine patch therapy prior to quitting smoking: a meta-analysis. Addiction. 2008 Apr;103(4):557-63. doi: 10.1111/j.1360-0443.2008.02138.x.
PubMed 18339101Bolliger CT, Zellweger JP, Danielsson T, van Biljon X, Robidou A, Westin A, Perruchoud AP, Sawe U. Smoking reduction with oral nicotine inhalers: double blind, randomised clinical trial of efficacy and safety. BMJ. 2000 Aug 5;321(7257):329-33. doi: 10.1136/bmj.321.7257.329.
PubMed 10926587Ebbert JO, Burke MV, Hays JT, Hurt RD. Combination treatment with varenicline and nicotine replacement therapy. Nicotine Tob Res. 2009 May;11(5):572-6. doi: 10.1093/ntr/ntp042. Epub 2009 Apr 7.
PubMed 19351781Bolliger CT, van Biljon X, Axelsson A. A nicotine mouth spray for smoking cessation: a pilot study of preference, safety and efficacy. Respiration. 2007;74(2):196-201. doi: 10.1159/000097136. Epub 2006 Nov 14.
PubMed 17108670Livingstone-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 37142273Koegelenberg CF, Noor F, Bateman ED, van Zyl-Smit RN, Bruning A, O'Brien JA, Smith C, Abdool-Gaffar MS, Emanuel S, Esterhuizen TM, Irusen EM. Efficacy of varenicline combined with nicotine replacement therapy vs varenicline alone for smoking cessation: a randomized clinical trial. JAMA. 2014 Jul;312(2):155-61. doi: 10.1001/jama.2014.7195.
PubMed 25005652
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
- ClinicalTrials.gov ID
- NCT01444131
- Acronym / sponsor ID
- VarNic
- Conditions
- Tobacco Dependence
- Keywords
- Smoking, Smoking cessation, Pharmaceutical aids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- University of StellenboschUniversity, hospital or other
- Collaborators
- QuitSupport
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe.
Detailed description
This is a phase-II multicenter study involving 438 smokers, to be conducted at 7 sites in South Africa, over 6 months. In a randomized 1:1 allocation varenicline tartrate 1 mg twice daily, given in an incremental dosage for the first week before target quit date (TQD), will be compared to varenicline tartrate in the same dose combined with a 15mg nicotine patch. The nicotine patch (active and placebo) will be provided by McNeil. The patch will be given 2 weeks prior TQD. Treatment duration from TQD is 12 weeks with varenicline being tapered off during week 13.
A total of 12 clinic visits and 1 telephonic contact is planned for the 6-month study duration. The main efficacy outcome will be the 4-week continuous abstinence rate during the last four weeks of treatment, i.e. weeks 9 - 12. Efficacy assessments will be based on a Nicotine Use Inventory and measurements of end-expiratory exhaled carbon monoxide. Safety assessments will be based on adverse events evaluation, with special attention being given to the occurrence of nausea during the pretreatment period, as well as neuro-psychiatric symptoms such as depression or suicidal ideation. Participants will not be subjected to any invasive procedures.
This protocol is based on current evidence and two further abstracts presented at the European Respiratory Society Conference in Vienna, September 2009, that a combination of varenicline tartrate and nicotine replacement therapy indicate superior efficacy in cessation rate, but also an excellent good safety profile.
This study relates to the area of pharmacotherapy of smoking cessation, and will answer a frequently asked question. Importantly, several leading pulmonologists with experience in smoking cessation in South Africa have expressed their keen interest to participate in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline and Placebo Patch | Placebo comparator | Drug: Varenicline and Placebo PatchVarenicline and Nicotine Patch (placebo) |
| Varenicline and Nicotine Patch | Active comparator | Drug: Varenicline, Nicotine PatchVarenicline and Nicotine Patch 15mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Current cigarette smokers, male and female, aged between 18-75 years (both limits inclusive), and who are motivated to stop smoking.
- Have smoked on average at least 10 cigarettes per day during past year and during the month prior to screening, and no period of abstinence greater than 3 months in the past year.
- Women of child-bearing potential (WCBP) may be included provided they are not pregnant, not nursing, and meet all of the following criteria:
- Patients must have no serious or unstable disease in the past 6 months.
- Patients must be able to be outpatients, to be assessed in a clinical setting, and be able and willing to comply with all study visits during the treatment and non-treatment periods.
Key exclusion criteria (20 listed)
- Patients currently suffering from depression or who have been diagnosed with depression or treated with anti-depressants within the past 12 months.
- Patients with a past of present history of psychosis, panic disorder, or bipolar disorder.
- Patients with severe chronic obstructive pulmonary disease (COPD).
- Patients with clinically significant cardiovascular disease in the past 6 months. such as myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), severe or unstable angina, serious arrhythmia, and clinically significant ECG conduction abnormalities.
- Patients with uncontrolled hypertension or a systolic blood pressure greater than 150mmHg or as diastolic pressure greater than 95mmHg at screening or baseline.
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 |
|---|---|---|
| Varenicline, Nicotine PatchAlso: Champix, Nicoretteactive nicotine patches added to varenicline. | Drug | Varenicline and Nicotine Patch |
| Varenicline and Placebo Patchplacebo nicotine patches added to varenicline. | Drug | Varenicline and Placebo Patch |
Primary outcome
continuous abstinence (CAR) from weeks 9 to 12 of treatment
Time frame: 3 months
The primary endpoint is the 4-week continuous abstincence rate for week 9 - 12 of treatment, i.e. the proportion of patients who are able to maintain complete abstinence from cigarette smoking and other nicotine use, with end-expiratory exhaled carbon monoxide (CO) measurements 10 ppm or less, for the planned last 4 weeks of treatment.
1 secondary outcome
CAR from weeks 9 to 24
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- Background: PubMed 16820546Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR; Varenicline Phase 3 Study Group. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):47-55. doi: 10.1001/jama.296.1.47.
- Background: PubMed 16820547Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR; Varenicline Phase 3 Study Group. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):56-63. doi: 10.1001/jama.296.1.56.
- Background: PubMed 16820548Tonstad S, Tonnesen P, Hajek P, Williams KE, Billing CB, Reeves KR; Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):64-71. doi: 10.1001/jama.296.1.64.
- Background: PubMed 10065662Tonnesen P, Paoletti P, Gustavsson G, Russell MA, Saracci R, Gulsvik A, Rijcken B, Sawe U. Higher dosage nicotine patches increase one-year smoking cessation rates: results from the European CEASE trial. Collaborative European Anti-Smoking Evaluation. European Respiratory Society. Eur Respir J. 1999 Feb;13(2):238-46. doi: 10.1034/j.1399-3003.1999.13b04.x.
- Background: PubMed 15078238Schuurmans MM, Diacon AH, van Biljon X, Bolliger CT. Effect of pre-treatment with nicotine patch on withdrawal symptoms and abstinence rates in smokers subsequently quitting with the nicotine patch: a randomized controlled trial. Addiction. 2004 May;99(5):634-40. doi: 10.1111/j.1360-0443.2004.00711.x.
- Background: PubMed 18339101Shiffman S, Ferguson SG. Nicotine patch therapy prior to quitting smoking: a meta-analysis. Addiction. 2008 Apr;103(4):557-63. doi: 10.1111/j.1360-0443.2008.02138.x.
- Background: PubMed 10926587Bolliger CT, Zellweger JP, Danielsson T, van Biljon X, Robidou A, Westin A, Perruchoud AP, Sawe U. Smoking reduction with oral nicotine inhalers: double blind, randomised clinical trial of efficacy and safety. BMJ. 2000 Aug 5;321(7257):329-33. doi: 10.1136/bmj.321.7257.329.
- Background: PubMed 19351781Ebbert JO, Burke MV, Hays JT, Hurt RD. Combination treatment with varenicline and nicotine replacement therapy. Nicotine Tob Res. 2009 May;11(5):572-6. doi: 10.1093/ntr/ntp042. Epub 2009 Apr 7.
- Background: PubMed 17108670Bolliger CT, van Biljon X, Axelsson A. A nicotine mouth spray for smoking cessation: a pilot study of preference, safety and efficacy. Respiration. 2007;74(2):196-201. doi: 10.1159/000097136. Epub 2006 Nov 14.
- 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 25005652Koegelenberg CF, Noor F, Bateman ED, van Zyl-Smit RN, Bruning A, O'Brien JA, Smith C, Abdool-Gaffar MS, Emanuel S, Esterhuizen TM, Irusen EM. Efficacy of varenicline combined with nicotine replacement therapy vs varenicline alone for smoking cessation: a randomized clinical trial. JAMA. 2014 Jul;312(2):155-61. doi: 10.1001/jama.2014.7195.
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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.
Elvis M Irusen, MBChB, FCP, PhD principal investigator
University of Stellenbosch
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Varenicline, Nicotine Patch in people with Tobacco Dependence, run by University of Stellenbosch at 7 sites in South Africa.
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 9 inclusion and 20 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 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Africa. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 abstinence (CAR) from weeks 9 to 12 of treatment (time frame: 3 months). 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 NCT01444131, which also lists 11 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 26 Mar 2014.