Clinical trial NCT01800019: The Canadian HIV Quit Smoking Trial: Tackling the Co-morbidities of Depression and Cardiovascular Disease in HIV+ Smokers
Official title: The Canadian HIV Quit Smoking Trial: Tackling the Co-morbidities of Depression and Cardiovascular Disease in HIV+ Smokers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV
Smoking Cessation
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: CIHR Canadian HIV Trials Network
First posted: 2013-02-27
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.
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.


Eligibility criteria: 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.

Primary outcomes:
measure: Smoking Status
timeFrame: at week 48
Secondary outcomes:
measure: Smoking Status: self report
timeFrame: quit date, weeks 4,8,12,16,20,24 and 48
measure: Smoking status: CO expired
timeFrame: randomization, quit date, 4, 8, 12, 16, 20, 24
measure: Smoking cessation treatment integrity and patient satisfaction
timeFrame: Baseline through Week 48
measure: Behavioral-Psychosocial
timeFrame: Baseline to Week 48
measure: Cardiovascular Parameters
timeFrame: From baseline through 48 weeks
measure: Immune Function
timeFrame: 12, 24, and 48 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Louise Balfour, PhD
role: PRINCIPAL_INVESTIGATOR
References: