Alcohol Clinical Trials Initiative (ACTIVE)

The mission of the Alcohol Clinical Trials Initiative (ACTIVE) workgroup is to develop consensus reviews and recommendations to improve the design, execution, and interpretation of trials of medications for the treatment of alcohol dependence. It is not the intention of the group to propose standards that would be considered as requirements for the approval of product applications by regulatory agencies, but to advance the science of clinical trials in alcoholism treatment. Although the primary interest at this time is in studies of medications to treat alcohol dependence, the recommendations of this group may also apply to non-drug treatments. The processes that lead to consensus reviews and recommendations in this area might be applied to the development of consensus reviews and recommendations for trials to treat other drug dependencies. In addition, the ASCP leadership believes ACTIVE could be a “model” for other industry, academic and government agencies initiatives.  The ACTIVE Workgroup is made up of two representatives from each of the supporting corporations, representatives from FDA, NIAAA, NIDA and several academic ACNP members.  We also have representation from the European Medications Agency (EMA) and an academic researcher from Germany.  The meetings began in January 2009 and have continued since.

 

ACTIVE Corporate Past Supporters:

  • Abbott
  • Alkermes
  • Eli Lilly & Company
  • GlaxoSmithKline
  • Janssen
  • Pfizer
  • Schering Plough

ACTIVE Corporate Current Supporters:

  • Amygdala Neurosciences, Inc.
  • Arbor Pharmaceuticals
  • Ethypharm
  • Lundbeck
  • Indivior
  • Otsuka

 ACTIVE Workgroup Meeting Summary:

ACTIVE Scientific Meeting Presentations:

2018

2017

2016

 ACTIVE Published and In-Press Papers 

  • Witkiewitz K, Kranzler HR, Hallgren KA, Hasin DE, Mann KF, Falk DE, Litten RZ, O’Malley SS, & Anton RF. Drinking Risk Level Reductions Associated with Improvements in Physical Health and Quality of Life Among Individuals with Alcohol Use Disorder. Alcoholism: Clinical and Experimental Research. (In-Press)
  • Knox J, Wall M, Witkiewitz K, Kranzler HR, Falk DE, Litten RZ, Mann KF, O’Malley SS, Scodes J, Anton RF, & Hasin DS. Reduction in Non-Abstinent WHO Drinking Risk Levels and Change in Risk for Liver Disease and Positive AUDIT-C Scores: Prospective 3-Year Follow-Up Results in the US General Population. Alcoholism: Clinical and Experimental Research. (In-Press)
  • Falk DE, O’Malley SS, Witkiewitz K, Anton RF, Litten RZ, Slater M, Kranzler HR, Mann KF, Hasin DF, Johnson B, Meulien D, Ryan M, & Fertig J. Reductions in Drinking Risk Level as Outcomes in Alcohol Pharmacotherapy Trials. JAMA Psychiatry. (In-Press)
  • Mann K, Aubin HJ, Charlet K, & Witkiewitz K. Can Reduced Drinking be a Viable Goal for Alcohol Dependent Patients? World Psychiatry. 2017 Oct; 16(3):325-326. PubMed PMID: 28941117; PubMed Central PMCID: PMC5608854.  
  • Mann K, Aubin HJ, & Witkiewitz K. Reduced Drinking in Alcohol Dependence Treatment, What is the Evidence? European Addiction Research. 2017 Sep 22;23(5):219-230. PubMed PMID: 28934736.
  • Litten RZ, Falk DE, O’Malley SS, Witkiewitz K, Mann KF, Anton RF. Letter to Editor in Response to Johnson’s Commentary (2017) on the Witkiewitz et al. (2017) Article. Alcoholism: Clinical and Experimental Research. 2017 May 4. PubMed PMID: 28471501.
  • Witkiewitz K, Wilson AD, Pearson MR, Hallgren KA, Falk DE, Litten RZ, Kranzler HR, Mann KR, Hasin DS, O’Malley SS, & Anton RF. Temporal Stability of Heavy Drinking Days and Drinking Reductions Among Heavy Drinkers in the COMBINE Study. Alcoholism: Clinical and Experimental Research. 2017 May;41(5):1054-1062. PubMed PMID: 28295414; PubMed Central PMCID: PMC5404970.
  • Hasin DS, Wall M, Witkiewitz K, Kranzler HR, Falk D, Litten RZ, Mann K, O’Malley SS, Scodes J, Robinson RL, Anton RF. Change in Non-Abstinent World Health Organization Risk Drinking Levels and Alcohol Dependence: A 3-Year Follow-Up Study in the United States General Population. Lancet Psychiatry. 2017 Jun; 4(6):469-476. PubMed PMID: 28456501.
  • Witkiewitz K, Hallgren KA, Kranzler HR, Mann KR, Hasin DS, Falk DE, Litten RZ, O’Malley SS, & Anton RF. Clinical Validation of Reduced Alcohol Consumption after Treatment for Alcohol Dependence using the World Health Organization Risk Drinking Levels. Alcoholism: Clinical and Experimental Research. 2017 Jan;41(1):179-186. PubMed PMID: 28019652; PubMed Central PMCID: PMC5205540.
  • Hallgren, KA, Witkiewitz K, Kranzler HR, Falk DE, Litten RZ, O’Malley SO, & Anton RF, in conjunction with the Alcohol Clinical Trials Initiative (ACTIVE) Workgroup. Missing Data in Alcohol Clinical Trials with Binary Outcomes. Alcoholism: Clinical and Experimental Research. 2016 Jul;40(7):1548-57. PMCID:PMC5522809.
  • Witkiewitz K, Falk DE, Kranzler HR, Litten RZ, Hallgren KA, O’Malley SS, & Anton RF. Methods to analyze treatment effects in the presence of missing data for a continuous heavy drinking outcome measure when participants drop out from treatment in alcohol clinical trials. Alcoholism: Clinical and Experimental Research. 2014 Nov;38(11):2826-34. PubMed PMID: 25421518; PubMed Central PMCID: PMC4244651.
  • Stout RL, Braciszewski JM, Subbaraman MS, Kranzler HR, O’Malley SS, Falk D and ACTIVE group. What happens when people discontinue taking medications? Lessons from COMBINE. Addiction. 2014 Dec; 109(12):2044-52. PubMed PMID: 25098969 PubMed Central PMCID: PMC4254710.
  • Falk DE, Litten RZ, Anton RF, Kranzler HR, Johnson BA, Active Workgroup. Cumulative proportion of responders analysis (CPRA) as a tool to assess treatment outcome in alcohol clinical trials. J Stud Alcohol Drugs. 2014 Mar;75(2):335-46. PubMed PMID: 24650828; PubMed Central PMCID: PMC3965687.
  • Greenfield TK, Ye Y, Bond J, Kerr WC, Nayak MB, Kaskutas LA, Anton RF, Litten RZ, Kranzler HR. Risks of alcohol use disorders related to drinking patterns in the US general population. J Stud Alcohol Drugs. 2014 Mar;75(2):319-27. PubMed PMID: 24650826; PubMed Central PMCID: PMC3965685.
  • Anton RF, Litten RZ, Falk DE, Palumbo JM, Bartus RT, Robinson RL, Kranzler HR, Kosten TR, Meyer RE, O’Brien CP, Mann K, Meulien D. The Alcohol Clinical Trials Initiative (ACTIVE): purpose and goals for assessing important and salient issues for medications development in alcohol use disorders. Neuropsychopharmacology. 2012 Jan;37(2):402-11. PubMed PMID: 21900883; PubMed Central PMCID: PMC3242301.