EXCEEDTHESPACE PROVIDED. Alcohol dependence is a chronic disorder that requires cliniciansto focus on both acute and long-term management. When patients relapse or fail treatment, it is imperativethat the overall management of patients be adjusted appropriately in order to provide the best long-term outcomes. Naltrexone has been established as an efficacious medication to treat alcohol dependence but studies thus far have focused mostly on the acute phase of treatment rather than long-term management and have not offered alternative treatment strategics when patients do not respond to an initial course of naltrexone. For these initial non-responders naltrexone, it is unclear what adjustments to treatment should be made to increase the likelihoodof treatment success. We are unaware of >revious research focused specifically on naltrexone non-response. Pilot data from ongoing trials at our center, lowever, suggest that up to a third of patients fail to respond to naltrexone. Moreover, these non-responsive patients go on to have the worst outcomes during the next 6 months of treatment if maintained on the same ombination of naltrexone and Medication Management (MM). We propose to augment medication management with a combination of motivational enhancement therapy and cognitive behavioral therapy (Combined Behavioral ntervention -CBI) and to tent the benefits of continued/discontinued treatment with naltrexone in a randomized lacebo-controlled trial. Clinical strategies for second line treatments often favor switching treatments rather than ugmentation. However, there may be synergies between naltrexone and CBI that were not apparent with medication management. Specifically, CBI may have advantages in motivatingpatients to greater medication dherence (a leadingcause of naltrexone treatment failure) and CBI may address psychosocial factors that limited or ttenuated the effects of naltrexone. PERFORMANCE SITE ========================================Section End===========================================

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Research Project (R01)
Project #
5R01AA014851-03
Application #
6945637
Study Section
Special Emphasis Panel (ZAA1-AA (04))
Program Officer
Mattson, Margaret
Project Start
2003-09-18
Project End
2008-08-31
Budget Start
2005-09-01
Budget End
2006-08-31
Support Year
3
Fiscal Year
2005
Total Cost
$669,781
Indirect Cost
Name
University of Pennsylvania
Department
Psychiatry
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Chakravorty, Subhajit; Chaudhary, Ninad S; Morales, Knashawn et al. (2018) Is family history of alcohol dependence a risk factor for disturbed sleep in alcohol dependent subjects? Drug Alcohol Depend 188:311-317
Lu, Xi; Nahum-Shani, Inbal; Kasari, Connie et al. (2016) Comparing dynamic treatment regimes using repeated-measures outcomes: modeling considerations in SMART studies. Stat Med 35:1595-615
Lu, Xi; Lynch, Kevin G; Oslin, David W et al. (2016) Comparing treatment policies with assistance from the structural nested mean model. Biometrics 72:10-9
Ertefaie, Ashkan; Wu, Tianshuang; Lynch, Kevin G et al. (2016) Identifying a set that contains the best dynamic treatment regimes. Biostatistics 17:135-48
Lei, H; Nahum-Shani, I; Lynch, K et al. (2012) A ""SMART"" design for building individualized treatment sequences. Annu Rev Clin Psychol 8:21-48
Chakravorty, Subhajit; Kuna, Samuel T; Zaharakis, Nikola et al. (2010) Covariates of craving in actively drinking alcoholics. Am J Addict 19:450-7
Murphy, Susan A; Lynch, Kevin G; Oslin, David et al. (2007) Developing adaptive treatment strategies in substance abuse research. Drug Alcohol Depend 88 Suppl 2:S24-30
Pettinati, Helen M; O'Brien, Charles P; Rabinowitz, Amanda R et al. (2006) The status of naltrexone in the treatment of alcohol dependence: specific effects on heavy drinking. J Clin Psychopharmacol 26:610-25
Oslin, David W (2005) Evidence-based treatment of geriatric substance abuse. Psychiatr Clin North Am 28:897-911, ix