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Nicotine Replacement Therapy

NRT and HIV Tailored Quit Smoking Counseling for HIV/AIDS (CANQUIT Trial)

Phase 3
Waitlist Available
Led By Louise Balfour, PhD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up quit date, weeks 4,8,12,16,20,24 and 48
Awards & highlights

Summary

This trial will determine if varenicline or NRT can help HIV+ individuals quit smoking, with fewer side effects, plus if HIV tailored counseling can help them quit.

Eligible Conditions
  • HIV/AIDS
  • Smoking Cessation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~quit date, weeks 4,8,12,16,20,24 and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and quit date, weeks 4,8,12,16,20,24 and 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Smoking Status
Secondary study objectives
Behavioral-Psychosocial
Cardiovascular Parameters
Immune Function
+3 more

Trial Design

4Treatment groups
Active Control
Group I: NRT and HIV Tailored Quit Smoking CounselingActive Control2 Interventions
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 II: NRT armActive Control1 Intervention
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 III: Varenicline (VR) and HIV Tailored Quit Smoking CounselingActive Control2 Interventions
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 IV: Varenicline (VR) ArmActive Control1 Intervention
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)

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
572 Previous Clinical Trials
2,788,766 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,373 Previous Clinical Trials
26,518,986 Total Patients Enrolled
CIHR Canadian HIV Trials NetworkNETWORK
40 Previous Clinical Trials
6,183 Total Patients Enrolled
~22 spots leftby Sep 2025
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