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

NCT01800019 | Unknown Phase 3 DMC

• 2 other identifiers: 2011824-01HCTN 269
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this trial are: Primary objectives:

1. 1.To determine among HIV+ individuals whether varenicline or NRT is more effective at helping individuals remain abstinent from smoking tobacco.
2. 2.To determine among HIV+ individuals whether varenicline or NRT has the lowest side-effect profile.
3. 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.

Conditions

HIV; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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.

  at week 48

Secondary Outcomes (6)

• Smoking Status: self report

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

• 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

• Cardiovascular Parameters

  From baseline through 48 weeks

Study Arms (4)

NRT 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.

Drug: Nicotine Replacement Therapy (NRT)

NRT and HIV Tailored Quit Smoking Counseling

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.

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

Varenicline (VR) Arm

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)

Drug: Varenicline

Varenicline (VR) and HIV Tailored Quit Smoking Counseling

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.

Drug: Varenicline; Behavioral: HIV Tailored Quit Smoking Counseling

Interventions

Nicotine Replacement Therapy (NRT) DRUG

Also known as: Nico-Derm®, Nicoderm, the patch, Nicorette®, the gum

NRT and HIV Tailored Quit Smoking Counseling; NRT arm

Varenicline DRUG

Also known as: Champix

Varenicline (VR) Arm; Varenicline (VR) and HIV Tailored Quit Smoking Counseling

HIV Tailored Quit Smoking Counseling BEHAVIORAL

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.

Also known as: Ottawa Model for Smoking Cessation

NRT and HIV Tailored Quit Smoking Counseling; Varenicline (VR) and HIV Tailored Quit Smoking Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• CIHR Canadian HIV Trials Network: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy; Nicotine; Nicotine Chewing Gum; Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinoxalines

Study Officials

• Louise Balfour, PhD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: February 27, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2019
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

CA (1)