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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
Approved for 5 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ quit date, weeks 4,8,12,16,20,24 and 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~quit date, weeks 4,8,12,16,20,24 and 48
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 moreAwards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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)
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Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
575 Previous Clinical Trials
3,094,644 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,389 Previous Clinical Trials
26,519,188 Total Patients Enrolled
CIHR Canadian HIV Trials NetworkNETWORK
40 Previous Clinical Trials
6,183 Total Patients Enrolled
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