NCT01800019

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV
• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Nicotine Replacement Therapy (NRT)
DRUG	Varenicline
BEHAVIORAL	HIV Tailored Quit Smoking Counseling	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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-12-01
• Completion: 2019-01-01
• First posted: 2013-02-27
• Last updated: 2015-12-14

Locations

1 site across 1 country: Canada