MedTrace Logo

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

NCT01800019 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2015-12-14

No results posted yet for this study

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

Interventions

DRUG

Nicotine Replacement Therapy (NRT)

DRUG

Varenicline

BEHAVIORAL

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • CIHR Canadian HIV Trials Network

    collaborator NETWORK

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Louise Balfour, PhD · Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-12-31
Completion
2019-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01800019 on ClinicalTrials.gov