HIVPhase 3CANQUITNCT01800019
The Canadian HIV Quit Smoking Trial: Tackling the Co-morbidities of Depression and Cardiovascular Disease in HIV+ Smokers
A Phase 3 study testing Nicotine Replacement Therapy (NRT), Varenicline and HIV Tailored Quit Smoking Counseling in people with HIV and Smoking Cessation, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The objectives of this trial are: Primary objectives: 1. To determine among HIV+ individuals whether varenicline or NRT is more effective at helping individuals remain abstinent from smoking tobacco. 2. To determine among HIV+ individuals whether varenicline or NRT has the lowest side-effect profile. 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Smoking Cessation
- What is being tested?
- Nicotine Replacement Therapy (NRT), Varenicline and HIV Tailored Quit Smoking Counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Jan 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV positive
- Adult (aged 18 or older)
- Current smoker (more than 5 cigarettes per day)
- Willing to set a date to quit smoking within the next 2-4 weeks
- Currently on ART with an undetectable HIV viral load
- Able to read/speak English or French
- Able to provide written, informed consent as approved by the Ottawa Health Science Network Research Ethics Board and REBs at participating HIV clinic sites
Who cannot join
- Contraindications to nicotine replacement therapy such as allergy to adhesive, serious cardiac arrhythmias (e.g., tachycardia), or vasospastic disease (e.g., Buerger's disease, Prinzmetal's variant angina)
- Contraindications to varenicline such as hypersensitivity to varenicline or to any ingredient in the formulation or component of the container.
- Reported previous severe intolerances to nausea or gastrointestinal symptoms.
- Pregnant, lactating or planning to become pregnant during the study period or refuses a serum beta-HCG test.
- Current severe renal impairment or currently taking Cimetidine
- Previous or current seizure disorder and/or is taking anti-epileptic drugs
Show all 10Show fewer
- Psychosis and/or is taking anti-psychotic drugs
- Diagnosed with severe major depressive episode requiring hospitalization within the past 12 months, previous psychiatric inpatient admission for any cause within the past 12 months, suicide attempt within the past 12 months active or current suicidal ideations as assessed by the BDI-II.
- Current use of bupropion, varenicline or any nicotine replacement therapy.
- Use of substances (e.g., crack cocaine) that would interfere with a participant's ability to adhere to the study schedule; determined by site coordinator's discretion.
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this trial are:
Primary objectives:
Read more
- To determine among HIV+ individuals whether varenicline or NRT is more effective at helping individuals remain abstinent from smoking tobacco.
- To determine among HIV+ individuals whether varenicline or NRT has the lowest side-effect profile.
- To determine if the HIV tailored Quit Smoking Counselling Intervention, plus smoking cessation drug therapy, improves smoking cessation rates compared to smoking cessation drug therapy alone with usual care.
Secondary objective:
- To determine whether the use of varenicline/NRT is safe in HIV+ patients who exhibit depressive symptoms.
Hypothesis:
That varenicline will result in higher quit smoking rates and that NRT will result in a lower side effect profile. Further, the HIV tailored quit smoking intervention will result in higher rates of smoking cessation over and above the pharmacological treatment alone. And finally, varenicline will be safe to use for HIV + individuals who exhibit depressive symptoms.
- Conditions
- HIV, Smoking Cessation
- Being tested
- Nicotine Replacement Therapy (NRT), Varenicline, HIV Tailored Quit Smoking Counseling
- 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 Replacement Therapy (NRT)Drug
Also called Nico-Derm®, Nicoderm, the patch, Nicorette®
VareniclineDrug
Also called Champix
HIV Tailored Quit Smoking CounselingBehavioural
Also called Ottawa Model for Smoking Cessation
A cognitive behavioral therapy (CBT) oriented smoking cessation program tailored to HIV positive individuals.
People Living with HIV/AIDS (PHA) tailored Canadian HIV Quit Smoking Counseling Intervention. It consists of face-to-face counseling sessions with a trained smoking cessation counsellor at randomization, on the identified quit date, and then at weeks 4, 8, 12, and 24.
| Study group | Role | What they receive |
|---|---|---|
| NRT arm | Active comparator | Drug: Nicotine Replacement Therapy (Nico-Derm® and Nicorette®)
Dose: 7mg - 42mg depending on # of cigarettes smoked per day at study baseline, and withdrawal symptoms.
Mode of Administration: Transdermal Patch
Duration of Treatment: up to 24 Weeks
Additionally, participants will be provided with a supply of short-acting nicotine gum in order to supplement their long acting NRT patch regimen.
Individuals who smoke their first cigarette more than 30 minutes after waking are advised to use the 2 mg NRT gum. Participants who smoke their first cigarette within 30 minutes of waking will be advised to use the 4 mg NRT gum. Both NRT gum dosages will be recommended for use on an ad lib basis to address cravings and/or withdrawal symptoms, up to a maximum of 12 pieces of NRT gum per day. Receives: Drug: Nicotine Replacement Therapy (NRT) |
| NRT and HIV Tailored Quit Smoking Counseling | Active comparator | Drug: Nicotine Replacement Therapy (Nico-Derm®)
Dose: 7mg - 42mg depending on # of cigarettes smoked per day at study randomization and withdrawal symptoms.
Mode of Administration: Transdermal Patch
Duration of Treatment: up to 24 Weeks
HIV tailored Smoking Cessation Counseling: The counseling consists of face-to-face sessions with a trained smoking cessation counselor at the start of the study, on your chosen quit date, and then at weeks 4, 8, 12 and 24; supportive telephone calls if needed. Receives: Drug: Nicotine Replacement Therapy (NRT); Behavioral: HIV Tailored Quit Smoking Counseling |
| Varenicline (VR) Arm | Active comparator | Drug: Varenicline (Champix®)
Doses: 0.5 mg once daily for 3 days(i.e.day 1-3 of the week prior to quit date) 0.5 mg twice daily for 4 days i.e. day 4-7) and 1 mg twice daily for the remainder of the treatment period
Mode of Administration: Oral
Duration of Treatment: 24 Weeks (+ 1 Week of Dose Escalation, total of 25 weeks) Receives: Drug: Varenicline |
| Varenicline (VR) and HIV Tailored Quit Smoking Counseling | Active comparator | Drug: Varenicline (Champix®)
0.5 mg once daily for 3 days(i.e.day 1-3 of the week prior to quit date) 0.5 mg twice daily for 4 days i.e. day 4-7) and 1 mg twice daily for the remainder of the treatment period
Mode of Administration: Oral
Duration of Treatment: 24 Weeks (+ 1 Week of Dose Escalation, total of 25 weeks)
Intervention: HIV tailored Smoking Cessation Counseling: The counseling consists of face-to-face sessions with a trained smoking cessation counselor at the start of the study, on your chosen quit date, and then at weeks 4, 8, 12 and 24; supportive telephone calls if needed. Receives: Drug: Varenicline; Behavioral: HIV Tailored Quit Smoking Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Status
The primary study end-point will be seven-day self-reported abstinence, and four week continuous abstinence rates at week 48, confirmed by expired carbon monoxide levels measured using a piCO+ Smokerlyzer (Smoke free defined as exhaled CO < 10 ppm). Study participants who are lost to follow-up (e.g., study drop-outs and those unavailable for follow-up) will be considered as smokers for the purposes of outcome analyses.
Measured: at week 48
Secondary outcomes (6)
Smoking Status: self report
Seven-day point-prevalence, and 4-week continuous abstinence(if time interval permits), assessed by self-report and by expired carbon monoxide levels measured using a piCO+ Smokerlyzer.
In addition, self-reported 4-week continuous abstinence rates (CAR) will be reported.
Measured: quit date, weeks 4,8,12,16,20,24 and 48
Smoking status: CO expired
Smoke free status will be objectively measured by exhaled CO levels (<10ppm) with a Bedfont Smokerlyzer instrument.
Measured: randomization, quit date, 4, 8, 12, 16, 20, 24
Smoking cessation treatment integrity and patient satisfaction
Study Medication: Adherence to NRT and varenicline will be assessed by participant self-reported adherence to medication at each study visit.
Counseling Intervention: Each clinic site will have an HIV clinic health care provider who will be trained in administering the standardized HIV quit smoking intervention.
Program Satisfaction Form will be completed by all study participants at the end of the study. At post-quit dates, treatment adherence will be assessed by a self-report measure of the amount of NRT or varenicline taken, number of cigarettes smoked in the previous 7 days, and marked changes in mood.
Study coordinator will assess rates of discontinuation of varenicline or NRT. Participants who discontinue varenicline or NRT will still be followed according to the original schedule.
Measured: Baseline through Week 48
Behavioral-Psychosocial
- The Minnesota Nicotine Withdrawal Scale
- The Center for Epidemiological Studies Depression Scale
- Smoking Self-Efficacy Questionnaire
- EuroQol(EQ-5D)This scale is a brief, standardized, generic measure of HR-QOL that provides a 5-item profile of patient function and a global health state rating
- Beck Depression Inventory
- Experiences in Close Relationships
- Stages of Change Questionnaire
- Adherence to Treatment Questionnaire
- Life Events Questionnaire
- Use of Cessation Resources Survey
Measured: Baseline to Week 48
Cardiovascular Parameters
The following parameters will be compared:
- Weight
- Height
- Waist circumference (defined by Heart and Stroke Foundation)
- Blood pressure
Measured: From baseline through 48 weeks
Immune Function
Changes in:
- CD4-T-lymphocyte count and percentage
- HIV viral load
- CD8-T-lymphocyte count and percentage
Measured: 12, 24, and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2017 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), CIHR Canadian HIV Trials Network
- Responsible party
- Sponsor
- Investigators
- Louise Balfour, PhD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800019
- Sponsor's protocol ID
- 2011824-01H
- Other IDs
- CTN 269
- Acronym
- CANQUIT
- Status last verified
- Dec 2015
- First submitted
- 25 Feb 2013
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Canadian HIV Quit Smoking Trial: Tackling the Co-morbidities of Depression and Cardiovascular Disease in HIV+ Smokers
- ClinicalTrials.gov ID
- NCT01800019
- Acronym / sponsor ID
- CANQUIT / 2011824-01H
- Conditions
- HIV, Smoking Cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), CIHR Canadian HIV Trials Network
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 27 Feb 2013 (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 objectives of this trial are:
Primary objectives:
- To determine among HIV+ individuals whether varenicline or NRT is more effective at helping individuals remain abstinent from smoking tobacco.
- To determine among HIV+ individuals whether varenicline or NRT has the lowest side-effect profile.
- To determine if the HIV tailored Quit Smoking Counselling Intervention, plus smoking cessation drug therapy, improves smoking cessation rates compared to smoking cessation drug therapy alone with usual care.
Secondary objective:
- To determine whether the use of varenicline/NRT is safe in HIV+ patients who exhibit depressive symptoms.
Hypothesis:
That varenicline will result in higher quit smoking rates and that NRT will result in a lower side effect profile. Further, the HIV tailored quit smoking intervention will result in higher rates of smoking cessation over and above the pharmacological treatment alone. And finally, varenicline will be safe to use for HIV + individuals who exhibit depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NRT arm | Active comparator | Drug: Nicotine Replacement Therapy (NRT)Drug: Nicotine Replacement Therapy (Nico-Derm® and Nicorette®) Dose: 7mg - 42mg depending on # of cigarettes smoked per day at study baseline, and withdrawal symptoms. Mode of Administration: Transdermal Patch Duration of Treatment: up to 24 Weeks Additionally, participants will be provided with a supply of short-acting nicotine gum in order to supplement their long acting NRT patch regimen. Individuals who smoke their first cigarette more than 30 minutes after waking are advised to use the 2 mg NRT gum. Participants who smoke their first cigarette within 30 minutes of waking will be advised to use the 4 mg NRT gum. Both NRT gum dosages will be recommended for use on an ad lib basis to address cravings and/or withdrawal symptoms, up to a maximum of 12 pieces of NRT gum per day. |
| NRT and HIV Tailored Quit Smoking Counseling | Active comparator | Drug: Nicotine Replacement Therapy (NRT), Behavioral: HIV Tailored Quit Smoking CounselingDrug: Nicotine Replacement Therapy (Nico-Derm®) Dose: 7mg - 42mg depending on # of cigarettes smoked per day at study randomization and withdrawal symptoms. Mode of Administration: Transdermal Patch Duration of Treatment: up to 24 Weeks HIV tailored Smoking Cessation Counseling: The counseling consists of face-to-face sessions with a trained smoking cessation counselor at the start of the study, on your chosen quit date, and then at weeks 4, 8, 12 and 24; supportive telephone calls if needed. |
| Varenicline (VR) Arm | Active comparator | Drug: VareniclineDrug: Varenicline (Champix®) Doses: 0.5 mg once daily for 3 days(i.e.day 1-3 of the week prior to quit date) 0.5 mg twice daily for 4 days i.e. day 4-7) and 1 mg twice daily for the remainder of the treatment period Mode of Administration: Oral Duration of Treatment: 24 Weeks (+ 1 Week of Dose Escalation, total of 25 weeks) |
| Varenicline (VR) and HIV Tailored Quit Smoking Counseling | Active comparator | Drug: Varenicline, Behavioral: HIV Tailored Quit Smoking CounselingDrug: Varenicline (Champix®) 0.5 mg once daily for 3 days(i.e.day 1-3 of the week prior to quit date) 0.5 mg twice daily for 4 days i.e. day 4-7) and 1 mg twice daily for the remainder of the treatment period Mode of Administration: Oral Duration of Treatment: 24 Weeks (+ 1 Week of Dose Escalation, total of 25 weeks) Intervention: HIV tailored Smoking Cessation Counseling: The counseling consists of face-to-face sessions with a trained smoking cessation counselor at the start of the study, on your chosen quit date, and then at weeks 4, 8, 12 and 24; supportive telephone calls if needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV positive
- Adult (aged 18 or older)
- Current smoker (more than 5 cigarettes per day)
- Willing to set a date to quit smoking within the next 2-4 weeks
- Currently on ART with an undetectable HIV viral load
Key exclusion criteria (10 listed)
- Contraindications to nicotine replacement therapy such as allergy to adhesive, serious cardiac arrhythmias (e.g., tachycardia), or vasospastic disease (e.g., Buerger's disease, Prinzmetal's variant angina)
- Contraindications to varenicline such as hypersensitivity to varenicline or to any ingredient in the formulation or component of the container.
- Reported previous severe intolerances to nausea or gastrointestinal symptoms.
- Pregnant, lactating or planning to become pregnant during the study period or refuses a serum beta-HCG test.
- Current severe renal impairment or currently taking Cimetidine
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 Replacement Therapy (NRT)Also: Nico-Derm®, Nicoderm, the patch, Nicorette® | Drug | NRT and HIV Tailored Quit Smoking Counseling, NRT arm |
| VareniclineAlso: Champix | Drug | Varenicline (VR) Arm, Varenicline (VR) and HIV Tailored Quit Smoking Counseling |
| HIV Tailored Quit Smoking CounselingAlso: Ottawa Model for Smoking CessationA cognitive behavioral therapy (CBT) oriented smoking cessation program tailored to HIV positive individuals. People Living with HIV/AIDS (PHA) tailored Canadian HIV Quit Smoking Counseling Intervention. It consists of face-to-face counseling sessions with a trained smoking cessation counsellor at randomization, on the identified quit date, and then at weeks 4, 8, 12, and 24. | Behavioural | NRT and HIV Tailored Quit Smoking Counseling, Varenicline (VR) and HIV Tailored Quit Smoking Counseling |
Primary outcome
Smoking Status
Time frame: at week 48
The primary study end-point will be seven-day self-reported abstinence, and four week continuous abstinence rates at week 48, confirmed by expired carbon monoxide levels measured using a piCO+ Smokerlyzer (Smoke free defined as exhaled CO < 10 ppm). Study participants who are lost to follow-up (e.g., study drop-outs and those unavailable for follow-up) will be considered as smokers for the purposes of outcome analyses.
6 secondary outcomes
Smoking Status: self report
Time frame: quit date, weeks 4,8,12,16,20,24 and 48
Smoking status: CO expired
Time frame: randomization, quit date, 4, 8, 12, 16, 20, 24
Smoking cessation treatment integrity and patient satisfaction
Time frame: Baseline through Week 48
Behavioral-Psychosocial
Time frame: Baseline to Week 48
Cardiovascular Parameters
Time frame: From baseline through 48 weeks
Immune Function
Time frame: 12, 24, and 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- 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.
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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.
Louise Balfour, PhD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nicotine Replacement Therapy (NRT), Varenicline and HIV Tailored Quit Smoking Counseling in people with HIV and Smoking Cessation, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 14 Dec 2015. 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 Canada. 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?
Results are not available in the source record.
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?
Smoking Status (time frame: at week 48). 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 NCT01800019, which also lists 1 linked publication.
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 14 Dec 2015.