Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04490057
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : November 6, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler Drug: Varenicline Behavioral: Contingency Management Phase 4

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 varenicline (VAR) 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 a Hybrid Effectiveness-Implementation Type I design, identify barriers and facilitators to delivering our intervention to inform future implementation.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 632 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential multiple assignment randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV
Actual Study Start Date : July 27, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Varenicline

Arm Intervention/treatment
Experimental: 12 wks NRT+CM / 12 wks NRT+CM
Nicotine replacement therapy combined with contingency management. Responders remain on same treatment for second 12 weeks.
Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.

Behavioral: Contingency Management
Particpants will be financially rewarded for abstinence to tobacco.

Experimental: 12 wks NRT+CM/ 12 wks VAR+CM
Nicotine replacement therapy combined with contingency management. Non-responders switch to varenicline combined with contingency management for second 12 weeks.
Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.

Drug: Varenicline
Participants will be prescribed varenicline (Chantix).

Behavioral: Contingency Management
Particpants will be financially rewarded for abstinence to tobacco.

Experimental: 12 wks NRT+CM/12 wks NRT+CM plus
Nicotine replacement therapy combined with contingency management Non-responders switch to nicotine replacement therapy combined with intensified contingency management for second 12 weeks.
Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.

Behavioral: Contingency Management
Particpants will be financially rewarded for abstinence to tobacco.

Experimental: 12 wks NRT/ 12 wks NRT
Nicotine replacement therapy alone. Responders remain on nicotine replacement therapy.
Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.

Experimental: 12 wks NRT/ 12 wks VAR
Nicotine replacement therapy alone. Non-responders switch to varenicline alone for second 12 weeks.
Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.

Drug: Varenicline
Participants will be prescribed varenicline (Chantix).

Experimental: 12 wks NRT/ 12 wks NRT+CM
Nicotine replacement therapy alone. Non-responders switch to nicotine replacement therapy combined with contingency management for second 12 weeks.
Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.

Behavioral: Contingency Management
Particpants will be financially rewarded for abstinence to tobacco.




Primary Outcome Measures :
  1. eCO confirmed abstinence at 24 weeks [ Time Frame: 24 weeks from baseline ]
    Abstinence from tobacco confirmed by exhaled carbon monoxide


Secondary Outcome Measures :
  1. VACS index 2.0 [ Time Frame: 24 weeks from baseline ]
    A validated measure of morbidity and mortalityviral load,

  2. CD4 Count [ Time Frame: 24 weeks from baseline ]
  3. HIV Viral Load [ Time Frame: 24 weeks from baseline ]

Other Outcome Measures:
  1. Identification of Barriers and Facilitators [ Time Frame: Baseline and Up to 4 years ]
    Using a Hybrid Effectiveness-Implementation Type I design, identify barriers and facilitators to delivering our intervention to inform future implementation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV positive;
  • Receiving HIV care at Yale-New Haven Hospital, Mount Sinai Hospital, or SUNY Downstate STAR clinic;
  • Have smoke >= 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 (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04490057


Contacts
Layout table for location contacts
Contact: Elizabeth Porter, MBA 203-737-3347 elizabeth.porter@yale.edu

Locations
Layout table for location information
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: E. Jennifer Edelman, MD, MHS    203-737-7115    ejennifer.edelman@yale.edu   
Contact: Elizabeth Porter, MBA    203-737-3347    elizabeth.porter@yale.edu   
Principal Investigator: E. Jennifer Edelman, MD, MHS         
United States, New York
SUNY Downstate STAR Clinic Recruiting
Brooklyn, New York, United States, 11203
Contact: Jessica Yager, MD       jessica.yager@downstate.edu   
Contact: Mayange Frederick    718-270-8641    mayange.frederick@downstate.edu   
Principal Investigator: Jessica Yager, MD         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Keith Sigel, MD       keith.sigel@mssm.edu   
Contact: Elisa McBratney    212-824-7455    elisa.mcbratney@mountsinai.org   
Sponsors and Collaborators
Yale University
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: E. Jennifer Edelman, MD, MHS Yale University
Principal Investigator: Steven Bernstein, MD Yale University
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04490057    
Other Study ID Numbers: 2000026332
R01CA243910 ( U.S. NIH Grant/Contract )
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action