Katie Witkiewitz1,2, John W Finney3, Alex H S Harris3,4, Daniel R Kivlahan5,6, Henry R Kranzler7,8. 1. Department of Psychology, University of New Mexico, Albuquerque, New Mexico. 2. Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, Albuquerque, New Mexico. 3. Center for Innovation to Implementation, VA Palo Alto Health Care System, Menlo Park, California. 4. VA Substance Use Disorder Quality Enhancement Research Initiative, VA Palo Alto Health Care System, Menlo Park, California. 5. Veterans Health Administration, Washington, District of Columbia. 6. Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington. 7. Center for Studies of Addiction, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. 8. VISN4 MIRECC, Philadelphia VAMC, Philadelphia, Pennsylvania.
Abstract
BACKGROUND: Over the past 60 years, the view that "alcoholism" is a disease for which the only acceptable goal of treatment is abstinence has given way to the recognition that alcohol use disorders (AUDs) occur on a continuum of severity, for which a variety of treatment options are appropriate. However, because the available treatments for AUDs are not effective for everyone, more research is needed to develop novel and more efficacious treatments to address the range of AUD severity in diverse populations. Here we offer recommendations for the design and analysis of alcohol treatment trials, with a specific focus on the careful conduct of randomized clinical trials of medications and nonpharmacological interventions for AUDs. METHODS: This paper provides a narrative review of the quality of published clinical trials and recommendations for the optimal design and analysis of treatment trials for AUDs. RESULTS: Despite considerable improvements in the design of alcohol clinical trials over the past 2 decades, many studies of AUD treatments have used faulty design features and statistical methods that are known to produce biased estimates of treatment efficacy. CONCLUSIONS: The published statistical and methodological literatures provide clear guidance on methods to improve clinical trial design and analysis. Consistent use of state-of-the-art design features and analytic approaches will enhance the internal and external validity of treatment trials for AUDs across the spectrum of severity. The ultimate result of this attention to methodological rigor is that better treatment options will be identified for patients with an AUD.
BACKGROUND: Over the past 60 years, the view that "alcoholism" is a disease for which the only acceptable goal of treatment is abstinence has given way to the recognition that alcohol use disorders (AUDs) occur on a continuum of severity, for which a variety of treatment options are appropriate. However, because the available treatments for AUDs are not effective for everyone, more research is needed to develop novel and more efficacious treatments to address the range of AUD severity in diverse populations. Here we offer recommendations for the design and analysis of alcohol treatment trials, with a specific focus on the careful conduct of randomized clinical trials of medications and nonpharmacological interventions for AUDs. METHODS: This paper provides a narrative review of the quality of published clinical trials and recommendations for the optimal design and analysis of treatment trials for AUDs. RESULTS: Despite considerable improvements in the design of alcohol clinical trials over the past 2 decades, many studies of AUD treatments have used faulty design features and statistical methods that are known to produce biased estimates of treatment efficacy. CONCLUSIONS: The published statistical and methodological literatures provide clear guidance on methods to improve clinical trial design and analysis. Consistent use of state-of-the-art design features and analytic approaches will enhance the internal and external validity of treatment trials for AUDs across the spectrum of severity. The ultimate result of this attention to methodological rigor is that better treatment options will be identified for patients with an AUD.
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: Justin Knox; Melanie Wall; Katie Witkiewitz; Henry R Kranzler; Daniel E Falk; Raye Litten; Karl Mann; Stephanie S O'Malley; Jennifer Scodes; Raymond Anton; Deborah S Hasin Journal: Drug Alcohol Depend Date: 2019-05-29 Impact factor: 4.492
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: Lancet HIV Date: 2019-05-17 Impact factor: 12.767
Authors: Justin Knox; Jennifer Scodes; Melanie Wall; Katie Witkiewitz; Henry R Kranzler; Daniel Falk; Raye Litten; Karl Mann; Stephanie S O'Malley; Raymond Anton; Deborah S Hasin Journal: Drug Alcohol Depend Date: 2019-02-14 Impact factor: 4.492
Authors: Emily T Noyes; Jacob A Levine; Robert C Schlauch; Cory A Crane; Gerard J Connors; Stephen A Maisto; Ronda L Dearing Journal: J Stud Alcohol Drugs Date: 2018-03 Impact factor: 2.582
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: Katie Witkiewitz; John W Finney; Alex H S Harris; Daniel R Kivlahan; Henry R Kranzler Journal: Alcohol Clin Exp Res Date: 2015-08-11 Impact factor: 3.455