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

Ottawa Hospital Research Institute

Status and phase: Unknown; Phase 3

Conditions: HIV; Smoking Cessation

Treatments: Behavioral: HIV Tailored Quit Smoking Counseling; Drug: Nicotine Replacement Therapy (NRT); Drug: Varenicline

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01800019

CTN 269 (Other Grant/Funding Number)

2011824-01H

Details and patient eligibility

About

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.

Enrollment: 256 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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256 participants in 4 patient groups

NRT arm

Active Comparator group

Description:

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.

Treatment:

Drug: Nicotine Replacement Therapy (NRT)

NRT and HIV Tailored Quit Smoking Counseling

Active Comparator group

Description:

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.

Treatment:

Drug: Nicotine Replacement Therapy (NRT)

Behavioral: HIV Tailored Quit Smoking Counseling

Varenicline (VR) Arm

Active Comparator group

Description:

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)

Treatment:

Drug: Varenicline

Varenicline (VR) and HIV Tailored Quit Smoking Counseling

Active Comparator group

Description:

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.

Treatment:

Drug: Varenicline

Behavioral: HIV Tailored Quit Smoking Counseling