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?
Many people living with HIV (PLWH) smoke. Smoking in these individuals is often undertreated. This study plans to assess the ability of various clinical pathways involving tobacco treatment medications and contingency management (paying smokers for not smoking) to improve smoking cessation in a group of PLWH.
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.
Is smoking cessation treatment safe for people with HIV?
Nicotine replacement therapy, bupropion, and varenicline are considered safe for smoking cessation, with regulatory agencies viewing them as having a favorable benefit/risk profile. However, patients should be monitored for neuropsychiatric symptoms, especially if they have a history of mental health issues.12345
How is the drug varenicline unique for helping people with HIV quit smoking?
Varenicline is unique for helping people with HIV quit smoking because it not only aids in smoking cessation but also may improve mood and cognitive function, which are common barriers for this group. Additionally, combining varenicline with text messaging and phone counseling can significantly increase adherence and smoking abstinence rates.678910
What data supports the effectiveness of the drugs used in smoking cessation therapies for people with HIV?
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:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator