TY - JOUR
T1 - The Alcohol Clinical Trials Initiative (ACTIVE)
T2 - Purpose and goals for assessing important and salient issues for medications development in alcohol use disorders
AU - Anton, Raymond F.
AU - Litten, Raye Z.
AU - Falk, Daniel E.
AU - Palumbo, Joseph M.
AU - Bartus, Raymond T.
AU - Robinson, Rebecca L.
AU - Kranzler, Henry R.
AU - Kosten, Thomas R.
AU - Meyer, Roger E.
AU - O'Brien, Charles P.
AU - Mann, Karl
AU - Meulien, Didier
N1 - Funding Information:
The ACTIVE workgroup has been, and is, supported by the following pharmaceutical companies through funding to the ACNP. The support provided covers the cost of meetings, honoraria for academic participants, and administrative support to ACNP. Staff members of government agencies receive no support for their participation. The FDA, NIAAA, and NIDA have provided in kind support for staff participation and data analysis. Travel expenses for industry representatives to attend ACTIVE meetings are supported by their respective companies. Those pharmaceutical companies are: Abbott Laboratories, Alkermes, Eli Lilly, GlaxoSmithKline, Johnson and Johnson Pharmaceuticals, Lundbeck, Schering Plough. Over the past 3 years, Dr RF Anton reports has been a consultant for Eli Lilly, Merck, Johnson and Johnson, GlaxoSmithKline, Organon and Alkermes; served as a scientific advisory board member for Eli Lilly and Johnson and Johnson; and received grant support from Eli Lilly, Merck, and Hythiam. He owns stock in Johnson and Johnson. He also is an officer and stockholder in Alcomed (funded by an STTR from NIDA). JM Palumbo, is a full time employee of Johnson and Johnson Pharmaceutical Research and Development, LLC. At the time of the submission of this paper, Johnson and Johnson does not sell or promote any therapeutic agent indicated for the treatment of alcoholism. A member of Dr Palumbo’s immediate family is employed by Actelion Clinical Research. Dr Palumbo declares no conflicts of interest that pertain to this publication. Dr RT Bartus is an officer of Ceregene and receives salary, compensation and stock options. He formerly worked for Alkermes and retains stock options in that company. RL Robinson is an employee and minor stockholder of Eli Lilly. Over the past 3 years, Dr HR Kranzler has been paid a consultant for Alkermes, GlaxoSmithKline and Gilead and has received research support from Merck. Over the past 3 years, Dr TR Kosten has received compensation for professional services from Reckitt Benckiser, Catalyst Pharma, Titan Pharma, Gerson Lerman, and Alkermes. Over the past 3 years, Dr RE Meyer received principal compensation from Best Practice Project Management. This company received support from the following companies in connection with a consensus development meeting on suicidality (Johnson and Johnson, Schering Plough, Pfizer, Forest, Astra Zeneca, Daishi Sumitomo, Sanofi-Aventis, Hoffman La Roche and United BioSource), as well as support for consulting from Takeda Pharmaceuticals. He has current and projected support from Forest for an investigator-initiated grant as a subcontractor from Northwestern University to Best Practice Project Management. During the past 3 years, Dr CP O’Brien has served as a consultant to Alkermes, Reckitt-Benckiser, Catalyst, Abbott, Embera, and Gilead. During the past 3 years, Dr K Mann has received compensation for professional services from Alkermes, Lundbeck, Johnson and Johnson, Pfizer, Merck, and Norgine. Over the past 3 years, Dr D Meulien declares that, except for income received from his primary employer Lundbeck, he has not received financial support or compensation from any individual or corporate entity for research or professional service and has no personal financial holdings that could be perceived as constituting a potential conflict of interest. The remaining authors declare no conflict of interest. The views expressed in this paper are those of the authors. No official endorsement by the US Department of Veterans Affairs, US Food and Drug Administration, US National Institutes of Health, or any of the pharmaceutical companies that provided grants to the American College of Neuropsycho-pharmaclogy should be inferred.
PY - 2012/1
Y1 - 2012/1
N2 - Although progress has been made in the treatment of alcohol use disorders, more effective treatments are needed. In the last 15 years, several medications have been approved for use in alcohol dependence but have only limited effectiveness and clinical acceptance. While academics have developed some standards for the performance of clinical trials for alcohol dependence, they vary considerably, in the type of populations to be studied, the length of trials, salient outcome measures, and data analyses to be used (especially in the treatment of missing data). This variability impedes the commercial development of medications to treat alcohol dependence. Using a model similar to that used to develop an expert consensus for medications to improve cognitive aspects of schizophrenia (MATRICS) and in the treatment of pain (IMMPACT), a workgroup has been formed under the auspices of ACNP, known as the ACTIVE (Alcohol Clinical Trials Initiative) group, to evaluate data from completed clinical trials to develop a consensus on key issues in the conduct of clinical trials in alcohol dependence. ACTIVE consists of academic experts, industry representatives, and staff from the Food and Drug Administration, the National Institute on Alcohol Abuse and Alcoholism, and the National Institute on Drug Abuse. This paper describes the rationale behind the effort, its history and organization, and initial key questions that have been identified as the primary focus of the workgroup. Future papers will focus on knowledge gained from the re-analysis of completed trials and provide consensus opinions regarding the performance of clinical trials that might be undertaken in the future.
AB - Although progress has been made in the treatment of alcohol use disorders, more effective treatments are needed. In the last 15 years, several medications have been approved for use in alcohol dependence but have only limited effectiveness and clinical acceptance. While academics have developed some standards for the performance of clinical trials for alcohol dependence, they vary considerably, in the type of populations to be studied, the length of trials, salient outcome measures, and data analyses to be used (especially in the treatment of missing data). This variability impedes the commercial development of medications to treat alcohol dependence. Using a model similar to that used to develop an expert consensus for medications to improve cognitive aspects of schizophrenia (MATRICS) and in the treatment of pain (IMMPACT), a workgroup has been formed under the auspices of ACNP, known as the ACTIVE (Alcohol Clinical Trials Initiative) group, to evaluate data from completed clinical trials to develop a consensus on key issues in the conduct of clinical trials in alcohol dependence. ACTIVE consists of academic experts, industry representatives, and staff from the Food and Drug Administration, the National Institute on Alcohol Abuse and Alcoholism, and the National Institute on Drug Abuse. This paper describes the rationale behind the effort, its history and organization, and initial key questions that have been identified as the primary focus of the workgroup. Future papers will focus on knowledge gained from the re-analysis of completed trials and provide consensus opinions regarding the performance of clinical trials that might be undertaken in the future.
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U2 - 10.1038/npp.2011.182
DO - 10.1038/npp.2011.182
M3 - Review article
C2 - 21900883
AN - SCOPUS:84856050408
SN - 0893-133X
VL - 37
SP - 402
EP - 411
JO - Neuropsychopharmacology
JF - Neuropsychopharmacology
IS - 2
ER -