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

NCT ID: NCT01800019

Last Updated: 2015-12-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2019-01-31

Brief 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.

Conditions

HIV; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Nicotine Replacement Therapy (NRT)

Intervention Type: 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.

Group Type: ACTIVE_COMPARATOR

Nicotine Replacement Therapy (NRT)

Intervention Type: DRUG

HIV Tailored Quit Smoking Counseling

Intervention Type: 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.

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)

Group Type: ACTIVE_COMPARATOR

Varenicline

Intervention Type: 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.

Group Type: ACTIVE_COMPARATOR

Varenicline

Intervention Type: DRUG

HIV Tailored Quit Smoking Counseling

Intervention Type: 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.

Interventions

Nicotine Replacement Therapy (NRT)

Intervention Type: DRUG

Varenicline

Intervention Type: DRUG

HIV Tailored Quit Smoking Counseling

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Nico-Derm®; Nicoderm; the patch; Nicorette®; the gum; Champix; Ottawa Model for Smoking Cessation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

CIHR Canadian HIV Trials Network

NETWORK

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louise Balfour, PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 37142273 (View on PubMed)

Other Identifiers

CTN 269

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011824-01H

Identifier Type: -

Identifier Source: org_study_id