Overview

This trial is active, not recruiting.

Conditions hiv, smoking cessation
Treatments nicotine replacement therapy (nrt), varenicline, hiv tailored quit smoking counseling
Phase phase 3
Sponsor Ottawa Hospital Research Institute
Collaborator Canadian Institutes of Health Research (CIHR)
Start date January 2014
End date December 2017
Trial size 256 participants
Trial identifier NCT01800019, 2011824-01H, CTN 269

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
nicotine replacement therapy (nrt) Nico-Derm®
(Active Comparator)
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.
nicotine replacement therapy (nrt) Nico-Derm®
hiv tailored quit smoking counseling Ottawa Model for Smoking Cessation
A cognitive behavioral therapy (CBT) oriented smoking cessation program tailored to HIV positive individuals. People Living with HIV/AIDS (PHA) tailored Canadian HIV Quit Smoking Counseling Intervention. It consists of face-to-face counseling sessions with a trained smoking cessation counsellor at randomization, on the identified quit date, and then at weeks 4, 8, 12, and 24.
(Active Comparator)
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)
varenicline Champix
(Active Comparator)
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.
varenicline Champix
hiv tailored quit smoking counseling Ottawa Model for Smoking Cessation
A cognitive behavioral therapy (CBT) oriented smoking cessation program tailored to HIV positive individuals. People Living with HIV/AIDS (PHA) tailored Canadian HIV Quit Smoking Counseling Intervention. It consists of face-to-face counseling sessions with a trained smoking cessation counsellor at randomization, on the identified quit date, and then at weeks 4, 8, 12, and 24.

Primary Outcomes

Measure
Smoking Status
time frame: at week 48

Secondary Outcomes

Measure
Smoking Status: self report
time frame: quit date, weeks 4,8,12,16,20,24 and 48
Smoking status: CO expired
time frame: randomization, quit date, 4, 8, 12, 16, 20, 24
Smoking cessation treatment integrity and patient satisfaction
time frame: Baseline through Week 48
Behavioral-Psychosocial
time frame: Baseline to Week 48
Cardiovascular Parameters
time frame: From baseline through 48 weeks
Immune Function
time frame: 12, 24, and 48 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title The Canadian HIV Quit Smoking Trial: Tackling the Co-morbidities of Depression and Cardiovascular Disease in HIV+ Smokers
Principal investigator Louise Balfour, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Ottawa Hospital Research Institute.