Varenicline + PSF-M for Smoking Cessation in HIV/AIDS
Trial Summary
What is the purpose of this trial?
This trial tests a mobile app and a medication to help people with HIV quit smoking. The app provides tips and support, while the medication reduces cravings. The study aims to see if this combination is more effective than standard care.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you must be able to use varenicline safely, which will be evaluated by your primary provider.
What data supports the effectiveness of the drug Varenicline for smoking cessation in people living with HIV/AIDS?
Is the combination of Varenicline and PSF-M safe for smoking cessation in people with HIV/AIDS?
Varenicline, used for smoking cessation, has been studied in people with HIV and is generally considered safe, though common side effects include nausea and sleep disturbances. Serious side effects are rare, but monitoring for changes in mood or behavior is recommended. In studies, it did not negatively affect HIV treatment outcomes.25678
How is the drug varenicline unique for smoking cessation in people with HIV/AIDS?
Varenicline is unique for smoking cessation in people with HIV/AIDS because it has been specifically studied for safety and effectiveness in this population, showing it can help reduce smoking without negatively affecting HIV treatment outcomes. It works by reducing nicotine withdrawal symptoms and cravings, and it has been found to be more effective than some other smoking cessation aids like bupropion.12569
Research Team
Gina Kruse, MD
Principal Investigator
University of Colorado, Denver
Eligibility Criteria
This trial is for adults over 18 with HIV who smoke tobacco, have a viral load under 1000 copies/mL, and CD4 count above 200 cells/mm3. They must read at a 6th-grade level in Tamil, Telugu or English and can safely use varenicline. Women must agree to contraception during the study.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Varenicline and Positively Smoke Free-Mobile intervention
Follow-up
Participants are monitored for tobacco abstinence and safety
Treatment Details
Interventions
- Positively Smoke Free Mobile (PSF-M) (Behavioral Intervention)
- Standard Care (Behavioral Intervention)
- Varenicline (Nicotinic Acetylcholine Receptor Partial Agonist)
Varenicline is already approved in Canada for the following indications:
- Smoking cessation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Dr. William Curry
Massachusetts General Hospital
Chief Medical Officer
MD from Harvard Medical School
Dr. Anne Klibanski
Massachusetts General Hospital
Chief Executive Officer since 2019
MD from Harvard Medical School
University of Colorado, Denver
Lead Sponsor
Aviva Abosch
University of Colorado, Denver
Chief Medical Officer since 2019
MD
Uday B. Kompella
University of Colorado, Denver
Chief Executive Officer since 2015
PhD in Pharmaceutical Sciences
National Cancer Institute (NCI)
Collaborator
Dr. Douglas R. Lowy
National Cancer Institute (NCI)
Chief Executive Officer since 2023
MD from New York University School of Medicine
Dr. Monica Bertagnolli
National Cancer Institute (NCI)
Chief Medical Officer since 2022
MD from Harvard Medical School