This proposal is for advanced training and mentored research for Dr. Nahvi to become an independent investigator in tobacco control among vulnerable populations. Building on intensive mentorship, didactic programs, and a strong research environment, the proposed research and career development plan will allow Dr. Nahvi to expand her training in the design and conduct of clinical trials;smoking cessation research methods;and the development and evaluation of tailored behavioral interventions for drug users. This training will foster Dr. Nahvi's development as an independent clinical investigator and guide a future R01 grant application to conduct a randomized trial of a tailored smoking cessation intervention for methadone maintained smokers. This proposal addresses two challenges in tobacco control research: 1) Determining effective interventions among populations with a disproportionately high tobacco use prevalence;and 2) promoting adherence to smoking cessation interventions. There is a marked prevalence of tobacco use and tobacco-related disease among methadone maintenance patients. Varenicline's demonstrated efficacy may not be generalizable to methadone maintained smokers because of poor adherence, which is highly prevalent among drug users. Adherence to smoking cessation medication is strongly associated with cessation, and is one of the few factors shown to increase cessation among methadone maintained smokers, but strategies to promote smoking cessation medication adherence have not been evaluated in methadone patients. Based on the Information, Motivation, and Behavior model, we propose a directly observed therapy (DOT)-based intervention targeting behavioral skills necessary for optimal adherence. Because methadone clinic-based DOT interventions have been shown to improve medication adherence and clinical outcomes in HIV and TB, we propose to determine in a randomized trial whether DOT varenicline provided at a methadone clinic is more efficacious than self- administered varenicline for promoting smoking cessation and enhancing adherence. We will also evaluate moderating effects of drug and alcohol use and psychiatric symptoms on DOT effects.

Public Health Relevance

Reducing tobacco use and increasing smoking cessation attempts among adults are objectives of Healthy People 2010, and determining strategies to increase use of proven cessation treatments was identified as a priority in the NIH State-of-the-Science statement on tobacco use. We hope to help methadone maintained smokers quit smoking by developing and evaluating an intervention to optimize smoking cessation medication use among methadone maintained smokers. If effective, this intervention has the potential to prevent cancer and other smoking-related diseases, and may save lives.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23DA025736-03
Application #
8311822
Study Section
Human Development Research Subcommittee (NIDA)
Program Officer
Montoya, Ivan
Project Start
2010-09-21
Project End
2015-08-31
Budget Start
2012-09-01
Budget End
2013-08-31
Support Year
3
Fiscal Year
2012
Total Cost
$181,741
Indirect Cost
$13,240
Name
Albert Einstein College of Medicine
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
110521739
City
Bronx
State
NY
Country
United States
Zip Code
10461
Nahvi, Shadi; Blackstock, Oni; Sohler, Nancy L et al. (2014) Smoking cessation treatment among office-based buprenorphine treatment patients. J Subst Abuse Treat 47:175-9
Nahvi, Shadi; Ning, Yuming; Segal, Kate S et al. (2014) Varenicline efficacy and safety among methadone maintained smokers: a randomized placebo-controlled trial. Addiction 109:1554-63
Nahvi, Shadi; Segal, Kate S; Litwin, Alain H et al. (2014) Rationale and design of a randomized controlled trial of varenicline directly observed therapy delivered in methadone clinics. Addict Sci Clin Pract 9:9
Nahvi, Shadi; Wu, Bryan; Richter, Kimber P et al. (2013) Low incidence of adverse events following varenicline initiation among opioid dependent smokers with comorbid psychiatric illness. Drug Alcohol Depend 132:47-52
Batchelder, A W; Brisbane, M; Litwin, A H et al. (2013) "Damaging what wasn't damaged already": Psychological tension and antiretroviral adherence among HIV-infected methadone-maintained drug users. AIDS Care :
Cooperman, Nina A; Heo, Moonseong; Berg, Karina M et al. (2012) Impact of adherence counseling dose on antiretroviral adherence and HIV viral load among HIV-infected methadone maintained drug users. AIDS Care 24:828-35
Nahvi, Shadi; Litwin, Alain H; Heo, Moonseong et al. (2012) Directly observed antiretroviral therapy eliminates adverse effects of active drug use on adherence. Drug Alcohol Depend 120:174-80
Southern, William N; Nahvi, Shadi; Arnsten, Julia H (2012) Increased risk of mortality and readmission among patients discharged against medical advice. Am J Med 125:594-602