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Reducing distress and tobacco smoking in cancer survivors: a TDCS telehealth study

Award Number: R21DA055426
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2022
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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Reducing distress and tobacco smoking in cancer survivors: a TDCS telehealth study - Project Summary/Abstract Cigarette smoking is the most prevalent cause of lung cancer, and also the strongest modifiable risk factor for cancer deaths among survivors. Unfortunately, the psychological distress associated with a cancer diagnosis makes smoking cessation particularly challenging for these patients. Distress itself is one of the core features of Koob & Volkow’s 3-stage model of addiction. Each of these stages is regulated by complementary brain circuits – which represent putative treatment targets. The long term goal of our research team is to develop an evidence- based brain stimulation treatment protocol for smoking cessation which is accessible, scalable, and an adjuvant to pharmacotherapy or psychotherapy among cancer survivors. Before embarking on a large multisite and multimodal clinical trial, however, it is critical to evaluate feasibility of delivering RS-tDCS to our target population (Aim 1) as well as estimated effect sizes on distress (Aim 2A) and smoking (Aim 2B). (Scientific Gap). Our team has developed and extensively validated a protocol for remotely supervised neuromodulation intervention which is delivered to participants at home and monitored by clinician during a telehealth visit. This remotely supervised technique utilizes transcranial direct current stimulation (RS-tDCS) and can be delivered safely via daily telehealth visits for extended treatment periods to provide cumulative benefit. Building on an established body of work, we seek to decrease distress among individuals with a prior cancer diagnosis and TUD via DLPFC tDCS. The goal of this proposal is to evaluate this technique as a feasible (Aim 1) tool to decrease distress and cigarette smoking (Aim 2) among this population. We propose a double-blind sham- controlled trial of a completely at-home intervention - RS-tDCS (DLFPC, 2.0 mA) paired with guided mindfulness meditation as a tool to decrease distress and smoking behavior among individuals with TUD. Eligible participants with a prior cancer diagnosis and TUD (n=46) will be randomized to active vs. sham tDCS for 20 daily (M-F) x 20 min sessions over one month, followed by 3 monthly follow up video visits. We hypothesize that active vs. sham tDCS will lead to greater reductions in distress and decrease smoking behaviors (Aim 2) by treatment end (primary) and through the 3 month follow up (secondary). The need for scalable, remote therapeutics which can be coupled with telehealth counseling techniques is more important than ever given the worldwide burden of COVID-19, including stay-at-home orders and an unprecedented acceleration in smoking and tobacco purchases. RS-tDCS as a tool to reduce distress and smoking behavior in people’s own homes represents a next-generation therapeutic approach– an important step forward for individuals struggling with a prior cancer diagnosis and current TUD, and is especially timely amidst the COVID-19 pandemic.


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: 2025 ( Subtotal = $0 )
2025	2023	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Drug Use and Addiction Research Programs	000	2	9/16/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $197,667 )
2023	2023	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Drug Use and Addiction Research Programs	001	2	7/19/2023	NON-COMPETING CONTINUATION	$197,667
2023	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Drug Use and Addiction Research Programs	000	1	1/4/2023	NEW	$0
														Subtotal = $197,667

Issue Date FY: 2022 ( Subtotal = $250,053 )
2022	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Drug Use and Addiction Research Programs	000	1	8/9/2022	NEW	$250,053
														Subtotal = $250,053

Grand Total All Awards = $447,720

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Reducing distress and tobacco smoking in cancer survivors: a TDCS telehealth study

Award Number: R21DA055426

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/15/2022

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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