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Achieving smoking cessation milestones in opioid treatment patients: a randomized 2 x 2 factorial trial of directly observed and long-term varenicline

Award Number: R01DA042813
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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ABSTRACT Tobacco use and tobacco-related disease are highly prevalent among persons with opioid use disorders (OUD). Unfortunately, traditional evidence-based smoking cessation interventions have yielded low rates of tobacco abstinence in this group. The majority of trials evaluating smoking cessation treatment interventions among persons with OUD have relied on short-term interventions that do not account for the unique challenges faced by these smokers, specifically, establishing initial abstinence, adhering to evidence-based cessation treatments, and maintaining abstinence once active treatments cease. Long-term smoking cessation medication treatment approaches have shown promise in promoting cessation and decreasing relapse among individuals without OUD, however the applicability of extended medication approaches to smokers with OUD may be limited by poor adherence to smoking cessation medications. Though adherence to cessation medication is strongly associated with cessation success, adherence is especially challenging for persons with OUD. Opioid treatment program-based directly observed therapy (DOT) interventions improve clinical outcomes in HIV and TB, and our pilot data suggest that DOT varenicline is associated with increased smoking cessation medication adherence and may increase smoking cessation rates. We therefore propose a 2 x 2 factorial, randomized, double-blind, placebo-controlled trial to efficiently test two interventions: directly observed medication therapy, and long-term therapy with varenicline. Our analytic strategy will evaluate the milestones in smoking cessation—achieving initial abstinence, preventing lapse and preventing relapse-- necessary for long-term cessation, and evaluate theoretically-guided psychological and social factors and pharmacogenetic factors that influence these cessation processes. We will recruit 450 smokers with OUD from community-based, outpatient opioid treatment programs and test the following specific aims: (1) to test the efficacy of directly observed varenicline therapy compared to self-administered varenicline therapy on smoking cessation milestones, (2) to test the efficacy of long-term varenicline compared to short-term varenicline on smoking cessation milestones, and (3) to understand the mechanism of smoking cessation by examining the impact of theory-guided psychological and social factors and of pharmacogenetic factors on cessation milestones. This proposal is innovative, and addresses the challenges of both promoting and maintaining tobacco abstinence among smokers with OUD.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Drug Abuse and Addiction Research Programs	000	6	1/3/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $656,466 )
2022	2022	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Drug Abuse and Addiction Research Programs	000	6	11/19/2021	NON-COMPETING CONTINUATION	$590,818
2022	2022	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Drug Abuse and Addiction Research Programs	001	6	3/18/2022	NON-COMPETING CONTINUATION	$65,648
														Subtotal = $656,466

Issue Date FY: 2021 ( Subtotal = $667,418 )
2021	2021	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Drug Abuse and Addiction Research Programs	000	5	11/13/2020	NON-COMPETING CONTINUATION	$600,675
2021	2021	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Drug Abuse and Addiction Research Programs	001	5	2/22/2021	NON-COMPETING CONTINUATION	$66,743
														Subtotal = $667,418

Issue Date FY: 2020 ( Subtotal = $680,578 )
2020	2020	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Drug Abuse and Addiction Research Programs	000	4	11/27/2019	NON-COMPETING CONTINUATION	$612,519
2020	2020	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Drug Abuse and Addiction Research Programs	001	4	2/13/2020	NON-COMPETING CONTINUATION	$68,059
														Subtotal = $680,578

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	ALBERT EINSTEIN COLLEGE OF MEDICINE, INC.	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Drug Abuse and Addiction Research Programs	001	2	2/13/2019	NON-COMPETING CONTINUATION	-$590,226
2019	2018	ALBERT EINSTEIN COLLEGE OF MEDICINE, INC.	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Drug Abuse and Addiction Research Programs	003	2	7/11/2019	NON-COMPETING CONTINUATION	-$92,188
2019	2018	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Drug Abuse and Addiction Research Programs	004	3	7/11/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$92,188
2019	2018	ALBERT EINSTEIN COLLEGE OF MEDICINE, INC.	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Drug Abuse and Addiction Research Programs	000	2	1/14/2019	NON-COMPETING CONTINUATION	$0
2019	2018	ALBERT EINSTEIN COLLEGE OF MEDICINE	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Drug Abuse and Addiction Research Programs	002	3	2/13/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$590,226
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $692,041 )
2018	2018	ALBERT EINSTEIN COLLEGE OF MEDICINE, INC.	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Drug Abuse and Addiction Research Programs	001	2	4/26/2018	NON-COMPETING CONTINUATION	$69,205
2018	2018	ALBERT EINSTEIN COLLEGE OF MEDICINE, INC.	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Drug Abuse and Addiction Research Programs	000	2	1/26/2018	NON-COMPETING CONTINUATION	$622,836
														Subtotal = $692,041

Issue Date FY: 2017 ( Subtotal = $709,277 )
2017	2017	ALBERT EINSTEIN COLLEGE OF MEDICINE, INC.	1300 MORRIS PARK AVE	BRONX	NY	10461	BRONX	USA	Drug Abuse and Addiction Research Programs	000	1	3/20/2017	NEW	$709,277
														Subtotal = $709,277

Grand Total All Awards = $3,405,780

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Achieving smoking cessation milestones in opioid treatment patients: a randomized 2 x 2 factorial trial of directly observed and long-term varenicline

Award Number: R01DA042813

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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