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Smoking Cessation Agent

Smoking Cessation Therapies for Quitting Smoking in People With HIV (SMARTTT Trial)

Phase 4

Waitlist Available

Led By E. Jennifer Edelman, MD, MHS

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

>= 18 years old

HIV positive;

Must not have

Life-threatening or unstable medical, surgical, or psychiatric condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and up to 4 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test different ways to help people with HIV quit smoking.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from the treatments could include skin irritation from patches, mouth issues from gum or inhaler use; nose problems from nasal spray; nausea or mood changes from Varenicline/bupropion; and stress due to quitting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am HIV positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe or unstable health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Self reported reduction in average cigarettes smoked per day at 12 weeks

Self reported reduction in average cigarettes smoked per day at 24 weeks

Secondary study objectives

CD4 Count

HIV Viral Load

VACS index 2.0

+2 more

Other study objectives

Identification of Barriers and Facilitators

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups

Experimental Treatment

Group I: 12 wks NRT/ 12 wks VAR or bupropionExperimental Treatment2 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+CMExperimental Treatment2 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 NRTExperimental Treatment1 Intervention

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

Group IV: 12 wks NRT+CM/12 wks NRT+CM plusExperimental Treatment2 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+CMExperimental Treatment3 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+CMExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contingency Management

2014

Completed Phase 4

~3440

0 / 3Eligibility criteria met