The Canadian HIV Quit Smoking Trial: Tackling the Co-morbidities of Depression and Cardiovascular Disease in HIV+ Smokers
This trial is active, not recruiting.
|Conditions||hiv, smoking cessation|
|Treatments||nicotine replacement therapy (nrt), varenicline, hiv tailored quit smoking counseling|
|Sponsor||Ottawa Hospital Research Institute|
|Collaborator||Canadian Institutes of Health Research (CIHR)|
|Start date||January 2014|
|End date||December 2017|
|Trial size||256 participants|
|Trial identifier||NCT01800019, 2011824-01H, CTN 269|
The objectives of this trial are:
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. 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.
1. To determine whether the use of varenicline/NRT is safe in HIV+ patients who exhibit depressive symptoms.
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||factorial assignment|
time frame: at week 48
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
time frame: Baseline to Week 48
time frame: From baseline through 48 weeks
time frame: 12, 24, and 48 weeks
Male or female participants at least 18 years old.
Inclusion Criteria: 1. HIV positive 2. Adult (aged 18 or older) 3. Current smoker (more than 5 cigarettes per day) 4. Willing to set a date to quit smoking within the next 2-4 weeks 5. Currently on ART with an undetectable HIV viral load 6. Able to read/speak English or French 7. Able to provide written, informed consent as approved by the Ottawa Health Science Network Research Ethics Board and REBs at participating HIV clinic sites Exclusion Criteria: 1. 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) 2. Contraindications to varenicline such as hypersensitivity to varenicline or to any ingredient in the formulation or component of the container. 3. Reported previous severe intolerances to nausea or gastrointestinal symptoms. 4. Pregnant, lactating or planning to become pregnant during the study period or refuses a serum beta-HCG test. 5. Current severe renal impairment or currently taking Cimetidine 6. Previous or current seizure disorder and/or is taking anti-epileptic drugs 7. Psychosis and/or is taking anti-psychotic drugs 8. 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. 9. Current use of bupropion, varenicline or any nicotine replacement therapy. 10. 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.
|Official title||The Canadian HIV Quit Smoking Trial: Tackling the Co-morbidities of Depression and Cardiovascular Disease in HIV+ Smokers|
|Principal investigator||Louise Balfour, PhD|
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