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A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV (SMARTTT)

Primary Purpose

Tobacco Use Cessation

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Varenicline or bupropion
Contingency Management
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV positive;
  • >= 18 years old
  • Receiving HIV care at Yale-New Haven Hospital, Mount Sinai Hospital, or SUNY Downstate STAR clinic;
  • Have smoked >= 100 cigarettes in lifetime;
  • Currently smokes some days or every day;
  • Smokes, on average, >= 5 cigarettes per day;
  • Able to provide written informed consent.

Exclusion Criteria:

  • Using only non-cigarette nicotine products (i.e., e-cigs, Juul, etc.);
  • Currently using NRT, VAR, or bupropion (defined as use in the prior 7 days);
  • Self-report or urine testing confirming pregnancy, nursing, or trying to conceive;
  • Life-threatening or unstable medical, surgical, or psychiatric condition;
  • Inability to provide at least one collateral contact (family member or friend);
  • Living out of state;
  • Unable to read or understand English (except at Mount Sinai site).

Sites / Locations

  • Yale University School of MedicineRecruiting
  • SUNY Downstate STAR ClinicRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

12 wks NRT+CM / 12 wks NRT+CM

12 wks NRT+CM/ 12 wks VAR or bupropion+CM

12 wks NRT+CM/12 wks NRT+CM plus

12 wks NRT/ 12 wks NRT

12 wks NRT/ 12 wks VAR or bupropion

12 wks NRT/ 12 wks NRT+CM

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Self reported reduction in average cigarettes smoked per day at 24 weeks
Self reported reduction in average cigarettes smoked per day
Self reported reduction in average cigarettes smoked per day at 12 weeks
Self reported reduction in average cigarettes smoked per day

Secondary Outcome Measures

VACS index 2.0
A validated measure of morbidity and mortality
CD4 Count
Median CD4 count adjusting for baseline
HIV Viral Load
The proportion of participants with HIV viral load suppression.
eCO confirmed smoking abstinence at 24 weeks
smoking abstinence confirmed by exhaled carbon monoxide
eCO confirmed smoking abstinence at 12 weeks
smoking abstinence confirmed by exhaled carbon monoxide

Full Information

First Posted
July 22, 2020
Last Updated
June 23, 2023
Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04490057
Brief Title
A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
Acronym
SMARTTT
Official Title
A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Using a Sequential Multiple Assignment Randomized Trial (SMART) design, this project is a two-arm, two-stage randomized trial of 632 adult PWH who smoke cigarettes and receive care in one of three health systems. At inception, participants will be randomized to either combination nicotine replacement therapy (NRT, patch + short-acting NRT) or combination NRT+contingency management (CM). At 12 weeks, responders (non-smoking participants confirmed by exhaled carbon monoxide [eCO]) in both arms will receive 12 more weeks of the same treatment. Non-responders (participants with continued smoking by self-report and/or eCO) in both the NRT and NRT+CM arms will be re-randomized to 12 weeks of treatment, either with medication switch to oral medication, varenicline or bupropion, or intensified level of CM (start CM if no CM during first 12 weeks, or CM with higher reward schedule ["CM plus"] if NRT+CM group initially). The intervention will be delivered by trained clinical pharmacists. The primary outcome will be eCO-confirmed abstinence at 24 weeks post-enrollment. The specific aims of the proposed study are to: (1) identify the optimal adaptive approach to promote eCO-confirmed smoking abstinence (2) study the effectiveness of various adaptive strategies on CD4 count, HIV viral suppression, and VACS index (validated measure of morbidity and mortality risk); and (3) grounded in implementation science and using aHybrid Effectiveness-Implementation Type I design, identify barriers and facilitators to delivering our intervention to inform future implementation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Model Description
Sequential multiple assignment randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
632 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
12 wks NRT+CM / 12 wks NRT+CM
Arm Type
Experimental
Arm Description
Nicotine replacement therapy combined with contingency management. Responders remain on same treatment for second 12 weeks.
Arm Title
12 wks NRT+CM/ 12 wks VAR or bupropion+CM
Arm Type
Experimental
Arm Description
Nicotine replacement therapy combined with contingency management. Non-responders switch to varenicline or bupropion combined with contingency management for second 12 weeks.
Arm Title
12 wks NRT+CM/12 wks NRT+CM plus
Arm Type
Experimental
Arm Description
Nicotine replacement therapy combined with contingency management Non-responders switch to nicotine replacement therapy combined with intensified contingency management for second 12 weeks.
Arm Title
12 wks NRT/ 12 wks NRT
Arm Type
Experimental
Arm Description
Nicotine replacement therapy alone. Responders remain on nicotine replacement therapy.
Arm Title
12 wks NRT/ 12 wks VAR or bupropion
Arm Type
Experimental
Arm Description
Nicotine replacement therapy alone. Non-responders switch to varenicline or bupropion alone for second 12 weeks.
Arm Title
12 wks NRT/ 12 wks NRT+CM
Arm Type
Experimental
Arm Description
Nicotine replacement therapy alone. Non-responders switch to nicotine replacement therapy combined with contingency management for second 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Intervention Description
Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.
Intervention Type
Drug
Intervention Name(s)
Varenicline or bupropion
Intervention Description
Participants will be prescribed varenicline (Chantix) or bupropion (Wellbutrin).
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
Participants will be financially rewarded for abstinence to tobacco.
Primary Outcome Measure Information:
Title
Self reported reduction in average cigarettes smoked per day at 24 weeks
Description
Self reported reduction in average cigarettes smoked per day
Time Frame
24 weeks from baseline
Title
Self reported reduction in average cigarettes smoked per day at 12 weeks
Description
Self reported reduction in average cigarettes smoked per day
Time Frame
12 weeks from baseline
Secondary Outcome Measure Information:
Title
VACS index 2.0
Description
A validated measure of morbidity and mortality
Time Frame
24 weeks from baseline
Title
CD4 Count
Description
Median CD4 count adjusting for baseline
Time Frame
24 weeks from baseline
Title
HIV Viral Load
Description
The proportion of participants with HIV viral load suppression.
Time Frame
24 weeks from baseline
Title
eCO confirmed smoking abstinence at 24 weeks
Description
smoking abstinence confirmed by exhaled carbon monoxide
Time Frame
24 weeks from baseline
Title
eCO confirmed smoking abstinence at 12 weeks
Description
smoking abstinence confirmed by exhaled carbon monoxide
Time Frame
12 weeks from baseline
Other Pre-specified Outcome Measures:
Title
Identification of Barriers and Facilitators
Description
Using a Hybrid Effectiveness-Implementation Type I design, identify barriers and facilitators to delivering our intervention to inform future implementation.
Time Frame
Baseline and Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV positive; >= 18 years old Receiving HIV care at Yale-New Haven Hospital, Mount Sinai Hospital, or SUNY Downstate STAR clinic; Have smoked >= 100 cigarettes in lifetime; Currently smokes some days or every day; Smokes, on average, >= 5 cigarettes per day; Able to provide written informed consent. Exclusion Criteria: Using only non-cigarette nicotine products (i.e., e-cigs, Juul, etc.); Currently using NRT, VAR, or bupropion (defined as use in the prior 7 days); Self-report or urine testing confirming pregnancy, nursing, or trying to conceive; Life-threatening or unstable medical, surgical, or psychiatric condition; Inability to provide at least one collateral contact (family member or friend); Living out of state; Unable to read or understand English (except at Mount Sinai site).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
June-Marie Weiss, MA, MEd
Phone
203-737-3347
Email
junemarie.weiss@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. Jennifer Edelman, MD, MHS
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Bernstein, MD
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E. Jennifer Edelman, MD, MHS
Phone
203-737-7115
Email
ejennifer.edelman@yale.edu
First Name & Middle Initial & Last Name & Degree
June-Marie Weiss, MA, MEd
Phone
203-737-3347
Email
junemarie.weiss@yale.edu
First Name & Middle Initial & Last Name & Degree
E. Jennifer Edelman, MD, MHS
Facility Name
SUNY Downstate STAR Clinic
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Yager, MD
Email
jessica.yager@downstate.edu
First Name & Middle Initial & Last Name & Degree
Mayange Frederick
Phone
718-270-8641
Email
mayange.frederick@downstate.edu
First Name & Middle Initial & Last Name & Degree
Jessica Yager, MD
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Sigel, MD
Email
keith.sigel@mssm.edu
First Name & Middle Initial & Last Name & Degree
Elisa McBratney
Phone
212-824-7455
Email
elisa.mcbratney@mountsinai.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33794354
Citation
Edelman EJ, Dziura J, Deng Y, Bold KW, Murphy SM, Porter E, Sigel KM, Yager JE, Ledgerwood DM, Bernstein SL. A SMARTTT approach to Treating Tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study. Contemp Clin Trials. 2021 Nov;110:106379. doi: 10.1016/j.cct.2021.106379. Epub 2021 Mar 29.
Results Reference
derived

Learn more about this trial

A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV

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