Sandra A Springer1, Angela Di Paola2, Marwan M Azar2, Russell Barbour3, Archana Krishnan4, Frederick L Altice5. 1. Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, Yale School of Medicine, 135 College Street, Suite 323, New Haven, CT 06510-2283, United States; Yale University School of Public Health, Center for Interdisciplinary Research on AIDS, New Haven, CT 06510-2283, United States. Electronic address: Sandra.springer@yale.edu. 2. Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, Yale School of Medicine, 135 College Street, Suite 323, New Haven, CT 06510-2283, United States. 3. Yale University School of Public Health, Center for Interdisciplinary Research on AIDS, New Haven, CT 06510-2283, United States. 4. State University of New York at Albany, Department of Communication, Albany, NY, United States. 5. Department of Internal Medicine, Section of Infectious Diseases, AIDS Program, Yale School of Medicine, 135 College Street, Suite 323, New Haven, CT 06510-2283, United States; Yale University School of Public Health, Center for Interdisciplinary Research on AIDS, New Haven, CT 06510-2283, United States; Yale University School of Public Health, Division of Epidemiology of Microbial Diseases, New Haven, CT, United States; Centre of Excellence in Research in AIDS (CERiA), University of Malaya, Kuala Lumpur, Malaysia.
Abstract
BACKGROUND: Alcohol use disorders (AUDs) are highly prevalent among persons living with HIV (PLH) within the criminal justice system (CJS). Extended-release naltrexone (XR-NTX) has not been previously evaluated among CJS-involved PLH with AUDs. METHODS: A randomized, double-blind, placebo-controlled trial was conducted among 100 HIV+ prisoners with AUDs. Participants were randomized 2:1 to receive 6 monthly injections of XR-NTX or placebo starting one week prior to release. Using multiple imputation strategies for data missing completely at random, data were analyzed for the 6-month post-incarceration period. Main outcomes included: time to first heavy drinking day; number of standardized drinks/drinking day; percent of heavy drinking days; pre- to post-incarceration change in average drinks/day; total number of drinking days; and a composite alcohol improvement score comprised of all 5 parameters. RESULTS: There was no statistically significant difference overall between treatment arms for time-to-heavy-drinking day. However, participants aged 20-29 years who receivedXR-NTX had a longer time to first heavy drinking day compared to the placebo group (24.1 vs. 9.5days; p<0.001). There were no statistically significant differences between groups for other individual drinking outcomes. A sub-analysis, however, found participants who received ≥4 XR-NTX were more likely (p<0.005) to have improved composite alcohol scores than the placebo group. Post-hoc power analysis revealed that despite the study being powered for HIV outcomes, sufficient power (0.94) was available to distinguish the observed differences. CONCLUSIONS: Among CJS-involved PLH with AUDs transitioning to the community, XR-NTX lengthens the time to heavy drinking day for younger persons; reduces alcohol consumption when using a composite alcohol consumption score; and is not associated with any serious adverse events. Published by Elsevier B.V.
RCT Entities:
BACKGROUND:Alcohol use disorders (AUDs) are highly prevalent among persons living with HIV (PLH) within the criminal justice system (CJS). Extended-release naltrexone (XR-NTX) has not been previously evaluated among CJS-involved PLH with AUDs. METHODS: A randomized, double-blind, placebo-controlled trial was conducted among 100 HIV+ prisoners with AUDs. Participants were randomized 2:1 to receive 6 monthly injections of XR-NTX or placebo starting one week prior to release. Using multiple imputation strategies for data missing completely at random, data were analyzed for the 6-month post-incarceration period. Main outcomes included: time to first heavy drinking day; number of standardized drinks/drinking day; percent of heavy drinking days; pre- to post-incarceration change in average drinks/day; total number of drinking days; and a composite alcohol improvement score comprised of all 5 parameters. RESULTS: There was no statistically significant difference overall between treatment arms for time-to-heavy-drinking day. However, participants aged 20-29 years who received XR-NTX had a longer time to first heavy drinking day compared to the placebo group (24.1 vs. 9.5days; p<0.001). There were no statistically significant differences between groups for other individual drinking outcomes. A sub-analysis, however, found participants who received ≥4 XR-NTX were more likely (p<0.005) to have improved composite alcohol scores than the placebo group. Post-hoc power analysis revealed that despite the study being powered for HIV outcomes, sufficient power (0.94) was available to distinguish the observed differences. CONCLUSIONS: Among CJS-involved PLH with AUDs transitioning to the community, XR-NTX lengthens the time to heavy drinking day for younger persons; reduces alcohol consumption when using a composite alcohol consumption score; and is not associated with any serious adverse events. Published by Elsevier B.V.
Authors: Jaimie P Meyer; Javier Cepeda; Johnny Wu; Robert L Trestman; Frederick L Altice; Sandra A Springer Journal: JAMA Intern Med Date: 2014-05 Impact factor: 21.873
Authors: Stephanie S O'Malley; James C Garbutt; David R Gastfriend; Qunming Dong; Henry R Kranzler Journal: J Clin Psychopharmacol Date: 2007-10 Impact factor: 3.153
Authors: Panagiotis Vagenas; Angela Di Paola; Maua Herme; Thomas Lincoln; Daniel J Skiest; Frederick L Altice; Sandra A Springer Journal: J Subst Abuse Treat Date: 2014-03-12
Authors: Josiah D Rich; David A Wohl; Curt G Beckwith; Anne C Spaulding; Nathaniel E Lepp; Jacques Baillargeon; Adrian Gardner; Ann Avery; Frederick L Altice; Sandra Springer Journal: Curr HIV/AIDS Rep Date: 2011-12 Impact factor: 5.071
Authors: Raymond F Anton; Stephanie S O'Malley; Domenic A Ciraulo; Ron A Cisler; David Couper; Dennis M Donovan; David R Gastfriend; James D Hosking; Bankole A Johnson; Joseph S LoCastro; Richard Longabaugh; Barbara J Mason; Margaret E Mattson; William R Miller; Helen M Pettinati; Carrie L Randall; Robert Swift; Roger D Weiss; Lauren D Williams; Allen Zweben Journal: JAMA Date: 2006-05-03 Impact factor: 56.272
Authors: Evgeny Krupitsky; Edward V Nunes; Walter Ling; Ari Illeperuma; David R Gastfriend; Bernard L Silverman Journal: Lancet Date: 2011-04-30 Impact factor: 79.321
Authors: Robert Miranda; Lara Ray; Alexander Blanchard; Elizabeth K Reynolds; Peter M Monti; Thomas Chun; Alicia Justus; Robert M Swift; Jennifer Tidey; Chad J Gwaltney; Jason Ramirez Journal: Addict Biol Date: 2013-03-13 Impact factor: 4.280
Authors: Livio Azzoni; Russell Barbour; Emmanouil Papasavvas; Deborah K Glencross; Wendy S Stevens; Mark F Cotton; Avy Violari; Luis J Montaner Journal: PLoS One Date: 2015-12-15 Impact factor: 3.240
Authors: Sandra A Springer; Angela Di Paola; Russell Barbour; Marwan M Azar; Frederick L Altice Journal: J Acquir Immune Defic Syndr Date: 2018-09-01 Impact factor: 3.731
Authors: Benjamin J Oldfield; Kathleen A McGinnis; E Jennifer Edelman; Emily C Williams; Adam J Gordon; Kathleen Akgün; Stephen Crystal; Lynn E Fiellin; Julie R Gaither; Joseph L Goulet; P Todd Korthuis; Brandon D L Marshall; Amy C Justice; Kendall Bryant; David A Fiellin; Kevin L Kraemer Journal: J Subst Abuse Treat Date: 2019-11-06
Authors: E Jennifer Edelman; Stephen A Maisto; Nathan B Hansen; Christopher J Cutter; James Dziura; Yanhong Deng; Lynn E Fiellin; Patrick G O'Connor; Roger Bedimo; Cynthia L Gibert; Vincent C Marconi; David Rimland; Maria C Rodriguez-Barradas; Michael S Simberkoff; Janet P Tate; Amy C Justice; Kendall J Bryant; David A Fiellin Journal: J Subst Abuse Treat Date: 2019-08-17
Authors: Sandra A Springer; Angela Di Paola; Marwan M Azar; Russell Barbour; Breanne E Biondi; Maureen Desabrais; Thomas Lincoln; Daniel J Skiest; Frederick L Altice Journal: J Acquir Immune Defic Syndr Date: 2018-05-01 Impact factor: 3.731
Authors: E Jennifer Edelman; Geliang Gan; James Dziura; Denise Esserman; Kenneth L Morford; Elizabeth Porter; Philip A Chan; Deborah H Cornman; Benjamin J Oldfield; Jessica E Yager; Srinivas B Muvvala; David A Fiellin Journal: J Acquir Immune Defic Syndr Date: 2021-07-01 Impact factor: 3.771
Authors: Jennifer A Wagman; Adriane Wynn; Mika Matsuzaki; Natalia Gnatienko; Lisa R Metsch; Carlos Del Rio; Daniel J Feaster; Robin M Nance; Bridget M Whitney; Joseph A C Delaney; Shoshana Y Kahana; Heidi M Crane; Redonna K Chandler; Jennifer C Elliott; Frederick Altice; Gregory M Lucas; Shruti H Mehta; Yael Hirsch-Moverman; Wafaa M El-Sadr; Quan Vu; Binh Nguyen Thanh; Sandra A Springer; Judith I Tsui; Jeffrey H Samet Journal: AIDS Date: 2020-12-01 Impact factor: 4.632