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

Ottawa Hospital Research Institute256 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

256

Conditions

HIV Smoking Cessation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Smoking Status

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.

Time frame: at week 48

Secondary Outcomes

Smoking Status: self report

Seven-day point-prevalence, and 4-week continuous abstinence(if time interval permits), assessed by self-report and by expired carbon monoxide levels measured using a piCO+ Smokerlyzer. In addition, self-reported 4-week continuous abstinence rates (CAR) will be reported.

Time frame: quit date, weeks 4,8,12,16,20,24 and 48

Smoking status: CO expired

Smoke free status will be objectively measured by exhaled CO levels (\<10ppm) with a Bedfont Smokerlyzer instrument.

Time frame: randomization, quit date, 4, 8, 12, 16, 20, 24

Smoking cessation treatment integrity and patient satisfaction

Study Medication: Adherence to NRT and varenicline will be assessed by participant self-reported adherence to medication at each study visit. Counseling Intervention: Each clinic site will have an HIV clinic health care provider who will be trained in administering the standardized HIV quit smoking intervention. Program Satisfaction Form will be completed by all study participants at the end of the study. At post-quit dates, treatment adherence will be assessed by a self-report measure of the amount of NRT or varenicline taken, number of cigarettes smoked in the previous 7 days, and marked changes in mood. Study coordinator will assess rates of discontinuation of varenicline or NRT. Participants who discontinue varenicline or NRT will still be followed according to the original schedule.

Time frame: Baseline through Week 48

Behavioral-Psychosocial

* The Minnesota Nicotine Withdrawal Scale * The Center for Epidemiological Studies Depression Scale * Smoking Self-Efficacy Questionnaire * EuroQol(EQ-5D)This scale is a brief, standardized, generic measure of HR-QOL that provides a 5-item profile of patient function and a global health state rating * Beck Depression Inventory * Experiences in Close Relationships * Stages of Change Questionnaire * Adherence to Treatment Questionnaire * Life Events Questionnaire * Use of Cessation Resources Survey

Time frame: Baseline to Week 48

Cardiovascular Parameters

The following parameters will be compared: 1. Weight 2. Height 3. Waist circumference (defined by Heart and Stroke Foundation) 4. Blood pressure

Time frame: From baseline through 48 weeks

Immune Function

Changes in: 1. CD4-T-lymphocyte count and percentage 2. HIV viral load 3. CD8-T-lymphocyte count and percentage

Time frame: 12, 24, and 48 weeks