Status:
UNKNOWN
The Canadian HIV Quit Smoking Trial: Tackling the Co-morbidities of Depression and Cardiovascular Disease in HIV+ Smokers
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
CIHR Canadian HIV Trials Network
Conditions:
HIV
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2019
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT01800019
Start Date
January 1 2014
End Date
January 1 2019
Last Update
December 14 2015
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6