Smoking Cessation Therapies for Quitting Smoking in People With HIV
(SMARTTT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help people living with HIV quit smoking by testing different combinations of smoking cessation treatments. Participants will try various methods such as nicotine patches, gum, or sprays, sometimes paired with contingency management (receiving payments for not smoking). The study will determine which approach best helps individuals stop smoking. It suits those who have HIV, smoke regularly, and receive care at specific hospitals. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, offering participants the opportunity to benefit from established therapies.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using nicotine replacement therapy, varenicline, or bupropion.
What is the safety track record for these treatments?
Research shows that the treatments used in this study are generally safe. Nicotine replacement therapy (NRT), which includes patches, gums, inhalers, and sprays, is well-researched and commonly used to help people quit smoking. The FDA has approved it, and it helps manage cravings by providing small amounts of nicotine without the harmful effects of smoking.
Contingency management, which uses financial rewards to encourage quitting smoking, has proven effective in many studies. It often supports behavior changes, like quitting smoking, and is considered safe.
Varenicline is another medication often used to help people stop smoking. Research has shown it to be safe, even for people with HIV, although some may experience side effects.
Bupropion is a medication that helps people quit smoking and also treats depression. It is known to be safe for people living with HIV and has been shown to aid in quitting smoking.
Overall, these treatments are well-tolerated, and substantial research backs their safety, especially since the study is in a later phase where safety is well-established.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the combination of smoking cessation therapies for people with HIV because it offers a multi-faceted approach to quitting smoking. Unlike standard nicotine replacement therapies (NRT) like patches or gum, this trial investigates combinations such as NRT with contingency management (CM), which uses positive reinforcement to encourage quitting. Additionally, non-responders have the option to switch to varenicline or bupropion, which are medications that target nicotine cravings differently by affecting brain chemistry. These varied strategies aim to address both the physical and psychological aspects of addiction, offering a personalized and potentially more effective path to quitting smoking for people living with HIV.
What evidence suggests that this trial's treatments could be effective for smoking cessation in people with HIV?
Research has shown that nicotine replacement therapy (NRT), such as patches or sprays, can help people quit smoking, especially when combined with support or counseling. In this trial, some participants will receive NRT alone, while others will receive NRT combined with contingency management, which offers payments as an incentive to quit. Varenicline is another treatment option in this trial. Studies have shown it to be effective for people with HIV, with about 34% quitting by the end of treatment. Bupropion is also under study in this trial and has helped people with HIV quit smoking, achieving nearly 40% success when used with counseling. Overall, these treatments have shown promise in helping people with HIV quit smoking.56789
Who Is on the Research Team?
E. Jennifer Edelman, MD, MHS
Principal Investigator
Yale University
Steven Bernstein, MD
Principal Investigator
Dartmouth College
Are You a Good Fit for This Trial?
This trial is for adults over 18 who are HIV positive, smoke cigarettes regularly, and receive care at specific hospitals. They must have smoked more than 100 cigarettes in their lifetime and currently smoke at least 5 a day. Pregnant or nursing individuals, non-cigarette nicotine users, those already on smoking cessation treatments, or with unstable health conditions cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Stage 1
Participants are randomized to either combination nicotine replacement therapy (NRT) or NRT with contingency management (CM) for 12 weeks
Treatment Stage 2
Responders continue with the same treatment for another 12 weeks. Non-responders are re-randomized to either switch medication or intensify CM
Follow-up
Participants are monitored for self-reported reduction in average cigarettes smoked per day and other health outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Bupropion
- Contingency Management
- Nicotine gum
- Nicotine inhaler
- Nicotine nasal spray
- Nicotine patch
- Varenicline
Bupropion is already approved in United States, European Union, Canada for the following indications:
- Major depressive disorder
- Seasonal affective disorder
- Smoking cessation
- Major depressive disorder
- Seasonal affective disorder
- Smoking cessation
- Smoking cessation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator