Wednesday, February 5, 2025 2/5/2025

Enhancing Exercise and Psychotherapy to Treat Comorbid Addiction and Pain for ImprovingAdherence to Medication Assisted Treatment in Opioid Use Disorders

Award Number: R33AT010806
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY Over 20.3 million adults in the U.S. are estimated to have a substance use disorder (SUD); and, an estimated 2 million Americans have had an opioid use disorder (OUD) involving prescription opioids and about 600,000 have had an OUD involving heroin. The number of overdose deaths from illicit opioids including heroin and synthetic opioids has tripled from 2011 to 2015 in the U.S. Among the more than half-million adults entering addiction treatment for prescription opioid abuse every year, 50%-60% report co-morbid chronic pain and 80% report that pain triggers relapse. High rates of relapse are not surprising because substance misuse may cause adverse structural and functional brain changes in the same brain regions that need to be engaged to initiate recovery and maintain abstinence. Exercise has been shown to reduce substance cravings and reduce depression and anxiety and may help reduce weight gain induced by methadone and anti-psychotic drug treatments; and, exercise, particularly at higher intensities, may produce an analgesic effect improving pain measures in chronic pain patients. Exercise may act by increasing growth and brain-derived neurotrophic factors that stimulate endogenous dopaminergic, opioidergic and serotoninergic systems that, in turn, enhance plasticity, learning and memory. These effects may help repair the structural and functional brain changes caused by substance abuse and chronic pain and help “offset” reward seeking and craving of substances while improving physical and mental health. However, most residential drug treatment programs do not currently offer a structured exercise program. We have developed an ‘assisted’ exercise technology that enables active patient engagement and mechanical assistance to help patients pedal faster than their voluntary rates. We have previously shown that ‘assisted’ exercise on a stationary cycle provides global improvements in motor function and increased activity in cortical and subcortical brain regions consistent with neural activation patterns after applying a dopamine agonist in Parkinson’s disease patients, suggesting that ‘assisted’ exercise may be modulating dopamine levels in the brain. In addition, we have shown that ‘assisted’ cycling improves motor function and recovery in stroke patients. We have also developed a novel self-regulation/cognitive behavioral therapy (CBT) program that co-addresses opioid addiction and pain (STOP), which has shown efficacy on pain tolerance, cravings and functional engagement in daily activities in outpatients. In response to RFA-AT-19-006, we propose to take a multi-phase optimization strategy (MOST) approach to refining our intervention protocols and testing feasibility with our community partners (R61 Phase) and evaluating the effects of exercise and I-STOP (STOP modified for inpatients) as adjunctive treatments to Medication Assisted Treatment (MAT) in adults with an OUD and chronic pain enrolled in residential treatment programs to decrease drug cravings and pain and increase adherence to MAT (methadone, buprenorphine) (R33 Phase).


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 = $870,587 )
2025	2025	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Research and Training in Complementary and Integrative Health	000	4	1/2/2025	NON-COMPETING CONTINUATION	$870,587
														Subtotal = $870,587

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Research and Training in Complementary and Integrative Health	001	3	6/12/2024	NON-COMPETING CONTINUATION	$0
2024	2023	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Research and Training in Complementary and Integrative Health	000	3	5/13/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $923,809 )
2023	2023	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Research and Training in Complementary and Integrative Health	001	3	6/23/2023	NON-COMPETING CONTINUATION	$868,868
2023	2023	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Research and Training in Complementary and Integrative Health	002	3	9/27/2023	NON-COMPETING CONTINUATION	$0
2023	2022	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Research and Training in Complementary and Integrative Health	000	2	5/3/2023	EXTENSION WITH OR WITHOUT FUNDS	$54,941
														Subtotal = $923,809

Issue Date FY: 2022 ( Subtotal = $944,737 )
2022	2022	CASE WESTERN RESERVE UNIVERSITY	10900 EUCLID AVE	CLEVELAND	OH	44106	CUYAHOGA	USA	Research and Training in Complementary and Integrative Health	000	2	8/26/2022	EXTENSION WITH OR WITHOUT FUNDS	$944,737
														Subtotal = $944,737

Grand Total All Awards = $2,739,133

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Enhancing Exercise and Psychotherapy to Treat Comorbid Addiction and Pain for ImprovingAdherence to Medication Assisted Treatment in Opioid Use Disorders

Award Number: R33AT010806

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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