drugset / Trial / NCT01800019

The Canadian HIV Quit Smoking Trial: Tackling the Co-morbidities of Depression and Cardiovascular Disease in HIV+ Smokers

NCT01800019

RandomizedFactorialOpen-labelTreatment

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. 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: 1\. 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.

Timeline

Start
2014-01
Primary completion
2017-12
Completion
2019-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nicotine Unknown 2 mg Other
Comparator Nicotine Unknown 4 mg Other
Comparator Nicotine Unknown 7 mg Other
Comparator Nicotine Unknown 42 mg Other
Comparator Varenicline Small molecule 1 mg Oral