The Canadian HIV Quit Smoking Trial: Tackling the Co-morbidities of Depression and Cardiovascular Disease in HIV+ Smokers
试验速览
- 阶段
- 3 期
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Smoking Status
研究概览
简要总结
The objectives of this trial are:
Primary objectives:
- To determine among HIV+ individuals whether varenicline or NRT is more effective at helping individuals remain abstinent from smoking tobacco.
- To determine among HIV+ individuals whether varenicline or NRT has the lowest side-effect profile.
- 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:
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
NRT arm
Drug: Nicotine Replacement Therapy (Nico-Derm® and Nicorette®)
Dose: 7mg - 42mg depending on # of cigarettes smoked per day at study baseline, and withdrawal symptoms.
Mode of Administration: Transdermal Patch
Duration of Treatment: up to 24 Weeks
Additionally, participants will be provided with a supply of short-acting nicotine gum in order to supplement their long acting NRT patch regimen.
Individuals who smoke their first cigarette more than 30 minutes after waking are advised to use the 2 mg NRT gum. Participants who smoke their first cigarette within 30 minutes of waking will be advised to use the 4 mg NRT gum. Both NRT gum dosages will be recommended for use on an ad lib basis to address cravings and/or withdrawal symptoms, up to a maximum of 12 pieces of NRT gum per day.
干预措施: Nicotine Replacement Therapy (NRT) (Drug)
NRT and HIV Tailored Quit Smoking Counseling
Drug: Nicotine Replacement Therapy (Nico-Derm®)
Dose: 7mg - 42mg depending on # of cigarettes smoked per day at study randomization and withdrawal symptoms.
Mode of Administration: Transdermal Patch
Duration of Treatment: up to 24 Weeks
HIV tailored Smoking Cessation Counseling: The counseling consists of face-to-face sessions with a trained smoking cessation counselor at the start of the study, on your chosen quit date, and then at weeks 4, 8, 12 and 24; supportive telephone calls if needed.
干预措施: Nicotine Replacement Therapy (NRT) (Drug)
NRT and HIV Tailored Quit Smoking Counseling
Drug: Nicotine Replacement Therapy (Nico-Derm®)
Dose: 7mg - 42mg depending on # of cigarettes smoked per day at study randomization and withdrawal symptoms.
Mode of Administration: Transdermal Patch
Duration of Treatment: up to 24 Weeks
HIV tailored Smoking Cessation Counseling: The counseling consists of face-to-face sessions with a trained smoking cessation counselor at the start of the study, on your chosen quit date, and then at weeks 4, 8, 12 and 24; supportive telephone calls if needed.
干预措施: HIV Tailored Quit Smoking Counseling (Behavioral)
Varenicline (VR) Arm
Drug: Varenicline (Champix®)
Doses: 0.5 mg once daily for 3 days(i.e.day 1-3 of the week prior to quit date) 0.5 mg twice daily for 4 days i.e. day 4-7) and 1 mg twice daily for the remainder of the treatment period
Mode of Administration: Oral
Duration of Treatment: 24 Weeks (+ 1 Week of Dose Escalation, total of 25 weeks)
干预措施: Varenicline (Drug)
Varenicline (VR) and HIV Tailored Quit Smoking Counseling
Drug: Varenicline (Champix®)
0.5 mg once daily for 3 days(i.e.day 1-3 of the week prior to quit date) 0.5 mg twice daily for 4 days i.e. day 4-7) and 1 mg twice daily for the remainder of the treatment period
Mode of Administration: Oral
Duration of Treatment: 24 Weeks (+ 1 Week of Dose Escalation, total of 25 weeks)
Intervention: HIV tailored Smoking Cessation Counseling: The counseling consists of face-to-face sessions with a trained smoking cessation counselor at the start of the study, on your chosen quit date, and then at weeks 4, 8, 12 and 24; supportive telephone calls if needed.
干预措施: Varenicline (Drug)
Varenicline (VR) and HIV Tailored Quit Smoking Counseling
Drug: Varenicline (Champix®)
0.5 mg once daily for 3 days(i.e.day 1-3 of the week prior to quit date) 0.5 mg twice daily for 4 days i.e. day 4-7) and 1 mg twice daily for the remainder of the treatment period
Mode of Administration: Oral
Duration of Treatment: 24 Weeks (+ 1 Week of Dose Escalation, total of 25 weeks)
Intervention: HIV tailored Smoking Cessation Counseling: The counseling consists of face-to-face sessions with a trained smoking cessation counselor at the start of the study, on your chosen quit date, and then at weeks 4, 8, 12 and 24; supportive telephone calls if needed.
干预措施: HIV Tailored Quit Smoking Counseling (Behavioral)
结局指标
主要结局
Smoking Status
时间窗: 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.
次要结局
- Cardiovascular Parameters(From baseline through 48 weeks)
- Smoking status: CO expired(randomization, quit date, 4, 8, 12, 16, 20, 24)
- Smoking cessation treatment integrity and patient satisfaction(Baseline through Week 48)
- Behavioral-Psychosocial(Baseline to Week 48)
- Smoking Status: self report(quit date, weeks 4,8,12,16,20,24 and 48)
- Immune Function(12, 24, and 48 weeks)