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

NCT01800019 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Ottawa Hospital Research Institute
Phase	Phase 3
Status	UNKNOWN
Enrolment	256
Start date	2014-01
Completion	2019-01

Conditions

• HIV
• Smoking Cessation

Interventions

• Nicotine Replacement Therapy (NRT)
• Varenicline
• HIV Tailored Quit Smoking Counseling

Primary outcomes

• Smoking Status — 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.

Countries

Canada