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Smoking Cessation Agent

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

Phase 4
Recruiting
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
>= 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to 4 years
Awards & highlights

SMARTTT 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.Check my eligibility
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.See study design
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.

SMARTTT Trial 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 18 years old or older.
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I am HIV positive.

SMARTTT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
CD4 Count
HIV Viral Load
VACS index 2.0
+2 more
Other outcome measures
Identification of Barriers and Facilitators

SMARTTT 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
2003
Completed Phase 2
~3220

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,841 Previous Clinical Trials
2,734,207 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,515 Total Patients Enrolled
2 Trials studying Quitting Smoking
13,098 Patients Enrolled for Quitting Smoking
E. Jennifer Edelman, MD, MHSPrincipal InvestigatorYale University
3 Previous Clinical Trials
586 Total Patients Enrolled

Media Library

Bupropion (Smoking Cessation Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04490057 — Phase 4
Quitting Smoking Research Study Groups: 12 wks NRT/ 12 wks VAR or bupropion, 12 wks NRT/ 12 wks NRT+CM, 12 wks NRT+CM / 12 wks NRT+CM, 12 wks NRT+CM/12 wks NRT+CM plus, 12 wks NRT/ 12 wks NRT, 12 wks NRT+CM/ 12 wks VAR or bupropion+CM
Quitting Smoking Clinical Trial 2023: Bupropion Highlights & Side Effects. Trial Name: NCT04490057 — Phase 4
Bupropion (Smoking Cessation Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04490057 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cohort size of this trial?

"Affirmative. Clinicaltrials.gov documents show that the clinical trial, which was first announced on July 27th 2020, is now seeking participants. 632 patients must be enlisted from three distinct research facilities."

Answered by AI

What maladies has Contingency Management been successful in mitigating?

"Contingency Management is a viable approach for treating attention deficit hyperactivity disorder (ADHD). Other conditions such as seasonal affective disorder, nicotine addiction and smoking cessation may also be managed using this technique."

Answered by AI

How efficacious is Contingency Management for patient health and wellbeing?

"The safety of Contingency Management has been substantiated by Phase 4 trials, thus earning a score of 3 out of the possible range."

Answered by AI

Is registration still open for the participants of this trial?

"Affirmative. The particulars of this medical trial, which was first released on July 27th 2020, is currently being updated on clinicaltrials.gov and searching for 632 participants from 3 different sites."

Answered by AI

What prior examinations have been conducted to assess the efficacy of Contingency Management?

"Contingency Management has a long history, having been initially researched by The University of Hong Kong in 2006. Since then 754 trials have concluded with an additional 113 presently underway; many of which are taking place within New Haven, Connecticut."

Answered by AI
Recent research and studies
~49 spots leftby Nov 2024