Smoking Cessation Therapies for Quitting Smoking in People With HIV

(SMARTTT Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by E. Jennifer Edelman, MD, MHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Yale University

No Placebo Group

Prior Safety Data

Trial Summary

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.

Eligibility Criteria

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

Receiving HIV care at Yale-New Haven Hospital, Mount Sinai Hospital, or SUNY Downstate STAR clinic

I am 18 years old or older.

You smoke at least five cigarettes a day.

Exclusion Criteria

Self-report or urine testing confirming pregnancy, nursing, or trying to conceive

Inability to provide at least one collateral contact (family member or friend)

Using only non-cigarette nicotine products (i.e., e-cigs, Juul, etc.)

Participant Groups

The study tests different methods to help people living with HIV quit smoking. It includes using nicotine patches, gums, nasal sprays, inhalers and medications like Varenicline or bupropion combined with Contingency Management which rewards participants for not smoking.

Group I: 12 wks NRT/ 12 wks VAR or bupropion Experimental Treatment 2 Interventions

Nicotine replacement therapy alone. Non-responders switch to varenicline or bupropion alone for second 12 weeks.

Group II: 12 wks NRT/ 12 wks NRT+CM Experimental Treatment 2 Interventions

Nicotine replacement therapy alone. Non-responders switch to nicotine replacement therapy combined with contingency management for second 12 weeks.

Group III: 12 wks NRT/ 12 wks NRT Experimental Treatment 1 Intervention

Nicotine replacement therapy alone. Responders remain on nicotine replacement therapy.

Group IV: 12 wks NRT+CM/12 wks NRT+CM plus Experimental Treatment 2 Interventions

Nicotine replacement therapy combined with contingency management Non-responders switch to nicotine replacement therapy combined with intensified contingency management for second 12 weeks.

Group V: 12 wks NRT+CM/ 12 wks VAR or bupropion+CM Experimental Treatment 3 Interventions

Nicotine replacement therapy combined with contingency management. Non-responders switch to varenicline or bupropion combined with contingency management for second 12 weeks.

Group VI: 12 wks NRT+CM / 12 wks NRT+CM Experimental Treatment 2 Interventions

Nicotine replacement therapy combined with contingency management. Responders remain on same treatment for second 12 weeks.

Bupropion is already approved in United States, European Union, Canada, Australia for the following indications:

🇺🇸 Approved in United States as Wellbutrin for:

• Major depressive disorder
• Seasonal affective disorder
• Smoking cessation

🇪🇺 Approved in European Union as Wellbutrin for:

• Major depressive disorder
• Seasonal affective disorder
• Smoking cessation

🇨🇦 Approved in Canada as Zyban for:

• Smoking cessation

🇦🇺 Approved in Australia as Wellbutrin for:

• Major depressive disorder
• Seasonal affective disorder
• Smoking cessation

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

SUNY Downstate STAR Clinic Brooklyn, NY

Bridgeport Hospital Infectious Disease Clinic Bridgeport, CT

Yale University School of Medicine New Haven, CT

Icahn School of Medicine at Mount Sinai New York, NY

Who Is Running the Clinical Trial?

Yale University Lead Sponsor

National Cancer Institute (NCI) Collaborator

References