Funding: Michael S. Businelle, Ph.D.


CURRENT RESEARCH SUPPORT

Principal Investigator
 
1. R01CA221819 (PI: Businelle)                                                                  02/01/2019-01/31/2024
NIH/NCI (Clinical Trials#: NCT03740490)
Smartphone Based Smoking Cessation Intervention for Socioeconomically Disadvantaged Adults
This study (N=450) will compare the longer-term effects of the Smart-T smoking cessation app with the free and publically available NCI QuitGuide smoking cessation app (Aim 1). The second aim will determine if Smart-T messages that are tailored to address key smoking lapse risk variables in real-time (i.e., urge, stress, cigarette availability, cessation motivation) reduce participant ratings of these lapse risk variables compared with similar situations that do not receive this tailored content (QuitGuide group).
Direct & Indirect: $2,695,044 (Direct: $1,858,651)
Effort: 23.3%

2. R01MD010733 (PIs: Businelle & Reingle)                                               09/26/2017-05/31/2022
NIH/NIMHD (Clinical Trials#: NCT03399500)
mHealth to Increase Service Utilization in Recently Incarcerated Homeless Adults
This 3-armed randomized clinical trial will use an innovative smartphone application to identify and address barriers that prevent recently incarcerated  homeless adults from obtaining available case management, crisis management, substance abuse, and mental health services.
Direct & Indirect: $3,326,084 (Direct: $2,627,219)
Effort: 25%

3. R34AA024584 (PIs: Businelle & Walters)                                                06/01/2018–05/31/2020
NIH/NIAAA (Clinical Trials#: NCT03746808)
Development and Testing of a Just-in-Time Adaptive Smart Phone Intervention to Reduce Drinking
among Homeless Adults
The aims of this study are to identify predictors of heavy drinking and develop and test a just-in-time adaptive intervention to prevent heavy drinking days in a sample of homeless adults with Alcohol Use Disorder.
Direct & Indirect: $665,384 (Direct: $515,108)
Effort: 15%

4. TSET 092-016-0002 (PIs: Businelle & Kendzor)                                     07/01/2019–06/01/2020
Oklahoma Tobacco Research Center
Direct & Indirect: $3,800,000 (Direct: $3,454,545)
Effort: 5%

5. OUHSC Pilot Funds  (PI: Businelle; NCT03405129)                               06/01/2018–05/31/2020
Project Phoenix: Pilot Intervention for Smokers Who Are Not Ready to Quit Smoking
The primary long-term objective of this research is to increase smoking cessation attempts and reduce smoking relapse through the use of automated phase based mobile smoking cessation interventions. The primary short-term objective of this pilot study is to determine the initial utility of the novel Phoenix smartphone based smoking cessation app.
Direct & Indirect: OUHSC funds

6. OUHSC Pilot Funds (PI: Businelle & Funk-Lawler)
Project Persist: mHealth for Cancer Survivorship
This pilot randomized controlled trial (RCT) will assess the initial feasibility of a phone-delivered intervention for anxiety and depressive symptoms among cancer patients that are receiving active radiation treatments. A total of 60 participants will be randomized to in-person and smartphone-based assessment only (n=30) or assessment plus smartphone-based intervention (n=30).

Co-Investigator

7. R01CA231952 (PIs: D. Vidrine & J. Vidrine)                                            04/01/2019–03/31/2024
NIH/NCI
Partnering with a State Food Bank to Provide Tobacco Treatment to Underserved Smokers
The overall goal of this project is to collaborate with a large food bank to evaluate the efficacy and economic impact of a theoretically-based, fully automated, interactive smartphone-based smoking cessation intervention.
Effort: 4%

8. P30 CA225520 (PI: Mannel; Businelle: Director mHeath Shared Resource)        05/01/2018–04/30/2023
NIH/NCI
Stephenson Cancer Center – Cancer Center Support Grant
Dr. Businelle is the Scientific Director of the NCI designated Stephenson Cancer Center mHealth Shared Resource. The shared resource enables researchers to rapidly create mobile applications that identify environmental, cognitive, affective, physiological and behavioral antecedents of cancer risk behaviors (e.g., smoking, heavy alcohol use, poor diet, inactivity, obesity, etc.) and deliver context-specific adaptive interventions in real time.
Total Direct: $7,000,000
Effort: 10%

9. U01 DA045537 (PI: Wagener)                                                                    8/01/2018–07/31/2020
NIH/NIDA
Switching to the SREC: Evaluating Risk Reduction among Quitline Treatment Failures
The specific aims of this project are: 1) to assess nicotine SREC vs. placebo SREC on product switching/substitution, craving/withdrawal, abuse liability, number of cigarettes smoked, and perceived nicotine dependence, 2) to evaluate changes in biomarkers of tobacco constituent exposure and physiological effects, and 3) to evaluate which e-cigarette device characteristics and perceived effects influence complete (vs. partial or no substitution).
Total Direct ($998,213) and Total Costs ($1,489,354)
Effort: 7.5%

10. R01CA197314 (PI: Kendzor)                                                                07/08/2015–06/30/2020
NIH/NCI
Small Financial Incentives to Promote Smoking Cessation in Safety Net Hospital Patients
This randomized clinical trial will examine the longer-term effects of offering small financial incentives for confirmed smoking abstinence in safety-net hospital patients who are seeking smoking cessation treatment. In addition, traditional and ecological momentary assessments will be used to identify antecedents of smoking lapse.
Total Direct ($1,127,995) and Total Costs ($1,619,450)
Effort: 5%

11. R21DA046333 (PIs: Wagener & Villanti)                                             09/15/2018–08/31/2020
NIH/NIDA
Addiction and Behavior Related to Menthol Cigarette Substitutes
This study will address an important gap in the menthol cigarette literature as to how alternative menthol tobacco products may serve as substitutes for menthol cigarettes in the context of a menthol ban in cigarettes and potentially undermine public health.
Total Direct Costs: $427,742
Effort: 4%

12. Project SmartPath (PI: Kendzor)                                                               09/01/2016–08/31/2019
OUHSC Pilot Funds
Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior
The aims of the study are to 1) evaluate the efficacy of a “real-time” smartphone intervention that works in conjunction with a wearable activity monitoring device to reduce sedentary time via smartphone prompts during prolonged sedentary bouts (relative to 2 comparison groups [AO and EQ]) and 2) to identify treatment mechanisms and contextual factors associated with sedentary behavior using traditional and ecological momentary assessment approaches.
Direct & Indirect: OUHSC funds

13. Grant/Contract Number: WI246498 (MPIs: Kendzor & Hébert)             12/15/2018–12/14/2020
OUHSC Pilot Funds and Pfizer (medication)
A comparison of the effectiveness of combination varenicline and oral nicotine
replacement therapy versus varenicline alone for smoking cessation: A pilot study
This pilot study will provide information regarding the feasibility, acceptability, and preliminary efficacy of combination varenicline and oral NRT for smoking cessation, which will support an NIH funding application for a larger, adequately powered study.
Total Costs ($150,000)
Effort: in kind

Consultant
 
14. R01NR017837 (PI: Santa Maria)                                                                    01/01/2019–05/31/2023  
NIH/NINR                                                                              
Come As You Are - Assessing the Efficacy of a Nurse Case Management HIV Prevention and Care Intervention among Homelessness Youth
This study is a randomized controlled trial of an enhanced Nurse Case Management intervention that will be delivered over 3 months to assess its impact on HIV risk behaviors.
Total Costs: $3,085,854
 
Mentor

15.   R01CA221819-01A1S1 (PI: Businelle)                                                        09/01/2019-01/31/2021
The Application of a Smartphone-Based Smoking Cessation Tool with American Indian Adults
This NCI Diversity Supplement will support Dr. Ashley Cole’s development into an independent researcher. This study involves qualatative examination of ways the Smart-T3 app can be culturally tailored for American Indian smokers seeking smoking cessation treatment.
Total costs: $327,562
Role: Mentor

16. K01HL148907 (PI: Alayna P. Tackett)                                                        08/21/2019-07/31/2024
NIH/NHLBI
Respiratory effects of E-Cigarette use among Youth: A prospective, longitudinal investigation
This Tobacco Regulatory K01 will provide much needed evidence regarding the immediate and longitudinal respiratory/pulmonary effects of youth electronic cigarette use.
Total costs: $963,190
Role: Mentor

17. K99DA046564 (PI: Emily Hébert)                                                             03/01/2019–02/28/2021
NIH/NIDA
Using Machine Learning to Develop Just-in-Time Adaptive Interventions for Smoking Cessation
Direct & Indirect: $179,883
Role: Primary mentor
 
18. F31DA047015 (PI: Samantha Schiavon)                                                  07/01/2018-05/31/2021
NIH/NIDA
Balanced Placebo Design with Varenicline: Pharmacological and Expectancy Effects on Medication Adherence
This double-blind placebo controlled trial is designed to differentiate expectancies
versus pharmacologic mechanisms of varenicline administered to treatment-seeking smokers.
Direct Costs: $102,223
Role: Mentor

COMPLETED RESEARCH SUPPORT

Principal Investigator

1. OUHSC Pilot Funds (PI: Businelle; NCT02930200)                                  09/01/2016–08/31/2018
Pilot Randomized Clinical Trial of an Automated Smartphone based Smoking Cessation Treatment
This pilot study is a 3 armed randomized clinical trial that aims to determine the initial utility of a novel smartphone based smoking cessation intervention (i.e., Smart-T) compared with standard in-person smoking cessation clinic care and the free NCI QuitGuide smoking cessation application. Results of this study will be used to support the development of a fully powered NCI R01 application.
Direct & Indirect: OUHSC funds

2. MRSG-12-114-01-CPPB (PI: Businelle)                                                 07/01/2012–07/10/2017
American Cancer Society (Mentored Research Scholar Grant)
Socioeconomic Disparities in Smoking Cessation: Identifying the Mechanisms
This study will determine if low SES increases the odds of relapse through a number of hypothesized mechanisms. This work is innovative because it will explore mediational pathways between SES and smoking cessation among individuals of varying racial/ethnic backgrounds from two distinct samples, using both traditional (questionnaire) and state-of-the-science real-time assessment methodology. This information was used to develop a new smart phone–based smoking cessation treatment that assesses relapse risk in real time and automatically intervenes to reduce risk (Project Smart-T).
Direct & Indirect Costs: $717,000

3. Project Advance II (PI: Businelle)                                                          06/29/2016–06/1/2018
Advance Understanding of Health in Homeless Shelter Patrons
The primary objective of this anonymous cross-sectional questionnaire study is to gain a better understanding of the prevalence of physical and mental health problems among homeless adults in Oklahoma City. The secondary objective is to identify risk (e.g., stress, pain) and protective (e.g., levels of social support) factors that have an impact on health behavior and health behavior change in this understudied and underserved population.
Direct & Indirect: OUHSC funds                                                             

4. Project Advance (PI: Businelle)                                                              05/01/2013–08/31/2014
University of Texas School of Public Health (GRA support) & The University of Texas MD Anderson Cancer Center (funded subject payments)
The Effects of a Smoking Policy Change at a Homeless Shelter
The primary objective of this project was to examine homeless individuals’ attitudes and beliefs about partial and full smoking bans at a local shelter before and after a partial smoking ban is implemented and to examine the short-term consequences of this ban. The secondary objective of this study was to determine the prevalence of modifiable cancer risk factors among a sample of homeless individuals.
Direct Costs (No Indirect Costs): $15,000
 
5. Start Up Project (Project Prevail; Co-PIs: Businelle & Kendzor)       08/23/2011–07/31/2013
University of Texas School of Public Health
Adjunctive Contingency Management to Promote Smoking Abstinence
The primary objectives of this study were: 1) to evaluate the efficacy of an adjunctive contingency management intervention for smokers of low socioeconomic status participating in a smoking cessation program at an urban safety net clinic (Parkland Tobacco Cessation Clinic), and 2) to identify barriers to smoking cessation and predictors of relapse in this population.
Direct Costs (No Indirect Costs): $85,000
 
6. PILOT Grant (Project Aspire; PI: Businelle)                               11/15/2011–02/15/2013
University of Texas School of Public Health
Reducing Tobacco Related Disparities among the Homeless
The primary objectives of this pilot project were to: 1) determine if ecological momentary assessment (EMA) methodology could be used to identify predictors of and barriers to successful smoking cessation in treatment seeking homeless smokers, and 2) determine if an adjunctive contingency management treatment component (i.e., small financial incentives for biologically confirmed abstinence) would increase abstinence relative to usual care in this population.
Direct Costs (No Indirect Costs): $25,000
 
7. Contract (PI for career development funds: Businelle; Effort: 50%)    09/01/2010–06/30/2012
UT Southwestern Medical Center/Harold C. Simmons Comprehensive Cancer Center
Population Level Research on Cancer Prevention
These funds were awarded to Dr. Businelle to support the development of his cancer prevention research laboratory in Dallas and to expedite research methods and data analysis for the Harold C. Simmons Comprehensive Cancer Center.
Direct Costs (No Indirect Costs): $90,654
 
8. R25-T CA57730 (PI: Chamberlain; PI for postdoctoral fellowship project: Businelle; Effort: 100%)
01/01/2008–12/31/2009
NIH/NCI
Pathways Linking Socioeconomic Status and Smoking Cessation
The major goal of this project was to examine pathways linking socioeconomic status to smoking cessation using a structural equation modeling approach.
Direct Costs (No Indirect Costs): $120,000
 
Co-Investigator

9. R01CA197314 Supplement (PI: Kendzor)                                               07/01/2016–06/30/2019
NIH/NCI Supplement
Mobile Contingency Management for Smoking Cessation Among Socioeconomically Disadvantaged Adults
The purpose of the supplement is to 1) develop a fully automated, mobile phone-based CM approach that can remotely verify smoking abstinence, confirm participant identity, and deliver financial incentives for smoking cessation, and 2) evaluate the feasibility and preliminary effectiveness of using a fully automated mobile CM approach as an adjunct to telephone counseling and nicotine replacement therapy among socioeconomically disadvantaged adults.
Total Direct ($80,550)
Effort: 10% year 1; in kind years 2-3

8. Houston Endowment Inc. (PI: Tortolero)                                                01/01/2015–11/30/2016
A Comprehensive Community-wide Approach to Adolescent Sexual Health
This study will use smart phone technology to assess health behaviors including sexual behavior, safe sex practices, and alcohol/drug use among a sample of at-risk adolescents and homeless youths. My role on this project is to guide the design of the smart phone–based data collection program and to assist with analyses of EMA data.
Total Direct Costs: $6,000,000; Current Year Direct Costs: $2,000,000
Effort: 10% in 2015; in kind 2016

9. U01AA016668 (PI: Adinoff)                                                                        02/01/2011–01/31/2013
NIH/NIAAA
Stress, HPA Axis Dysfunction, and Relapse in Alcoholism
The primary goal of this project was to examine the interaction between stress and HPA axis dysfunction and its impact on relapse in a sample of alcohol dependent men.
Subcontract Direct Costs (No Indirect Costs): $24,954
Effort: 10%                                                

10. IRG-02-196-07 (PI: Kendzor)                                                                   01/06/2014–10/01/2015
American Cancer Society (Institutional Research Grant)
Evaluation of a Shelter-Based Diet and Physical Activity Intervention for Homeless Adults: A Pilot Study
This pilot randomized clinical trial will evaluate the feasibility and effectiveness (relative to an assessment-only control group) of a shelter-based intervention designed to improve dietary intake and increase physical activity among homeless individuals.
Direct Costs (No Indirect Costs): $30,000
 
Mentor

11. R25/CA57712 (PI: Mullen)                                                                      09/01/2013–10/1/2015
NCI/NIH
Behavioral Science Education-Cancer Prevention and Control
Direct and Indirect Costs: $2,499,817

12. CPRIT (PIs: Ness & Mullen)  2014-2015
Collaborative Training of a New Cadre of Innovative Cancer Prevention Researchers
Direct and Indirect Costs: $1,700,000
Role: Mentor (in Kind)

13. P50 CA180906 (PI: Cooper)                                                                      09/01/2015–10/31/2015
NIH/NCI TCORS Pilot Grant
Assessing Young Adult E-cigarette Use with Ecological Momentary Assessment
The purpose of thise study is to investigate e-cigarette use behaviors and antecedents associated with use among young adults.
Direct costs: $19,235 (no indirect costs)
Role: Mentor (in Kind)

Consultant

14. R25 HD045810 to University of California, San Francisco               09/1/2016–8/31/2017
NIH, NICHD - Center for AIDS Prevention Studies (PI: Santa Maria)
Development of a HIV Risk Estimator to Predict Imminent HIV Risk Behaviors in Homeless Youth
The goal of this project is to identify antecedents to HIV risk behaviors and combine this information to develop a real-time HIV risk estimator using existing EMA data from 71 homeless 18-24 year olds recruited from a local drop-in center in Houston, TX.
Direct and Indirect Costs: $20,000

15. PARTNERS Foundation (PI: Santa Maria)                                               08/01/2018–07/31/2019
MY-RID: Motivating Youth to Reduce Infections and Disconnections
Using a participatory research model, a personalized nurse-led, mobile enhanced, HIV prevention intervention for youth experiencing homelessness and unstably housing will be developed. Once developed and beta tested, we will conduct a small randomized attention control trial to assess the feasibility, acceptability, and preliminary efficacy of the intervention.
Direct & Indirect: $100,000
Role: Consultant
 
16. DSRIP (1115) (PI: Walters)                                                                      01/26/2014–12/31/2016
Centers for Medicare & Medicaid Services, Delivery System Reform Incentive Payment Program
Health Navigation Incentives for Dual Diagnosis Patients
Provide consultation on the development of an application that uses mobile technology for real-time assessment and intervention among people enrolled in Fort Worth permanent supportive housing.
Direct and Indirect Costs: $2,488,150