The role of biomarkers in alcoholism medication trials
- PMID: 11505042
The role of biomarkers in alcoholism medication trials
Abstract
Background: Increasingly, biomarkers are being incorporated into the research design of clinical trials on medications to reduce drinking in alcoholics. To date, however, there has been little analysis of the unique roles that biomarkers can play in such investigations or of the practical and conceptual considerations that surround their best use in this context.
Methods: Clinical trials of alcoholism medications published between 1985 and the present were abstracted to determine how biomarkers were used and how changes in them related to self-report measures of drinking.
Results: Six uses of biomarkers were identified: determination of subjects to be included or excluded in the trial; description of baseline sample characteristics; primary and secondary outcome assessment; corroboration of self-reports of drinking status; specification of patients likely to respond to the medication; and evaluation of drug safety.
Conclusion: Use of biomarkers in such studies appears warranted, particularly as an objective source of information on treatment efficacy that can be considered with patient self-report measures of drinking status. Biomarkers related to liver functioning also can assist in determination of drug safety for medications metabolized by the liver.
Similar articles
-
Recommendations on use of biomarkers in alcoholism treatment trials.Alcohol Clin Exp Res. 2003 Oct;27(10):1667-70. doi: 10.1097/01.ALC.0000091224.78880.47. Alcohol Clin Exp Res. 2003. PMID: 14574239
-
Validity of carbohydrate-deficient transferrin (%CDT), gamma-glutamyltransferase (gamma-GT) and mean corpuscular erythrocyte volume (MCV) as biomarkers for chronic alcohol abuse: a study in patients with alcohol dependence and liver disorders of non-alcoholic and alcoholic origin.Addiction. 2005 Oct;100(10):1477-86. doi: 10.1111/j.1360-0443.2005.01216.x. Addiction. 2005. PMID: 16185209
-
DOVER and QUVER-new marker combinations to detect and monitor at-risk drinking.Alcohol Clin Exp Res. 2006 Aug;30(8):1372-80. doi: 10.1111/j.1530-0277.2006.00163.x. Alcohol Clin Exp Res. 2006. PMID: 16899040
-
The status of naltrexone in the treatment of alcohol dependence: specific effects on heavy drinking.J Clin Psychopharmacol. 2006 Dec;26(6):610-25. doi: 10.1097/01.jcp.0000245566.52401.20. J Clin Psychopharmacol. 2006. PMID: 17110818 Review.
-
Biochemical alcohol screening in primary health care.Addict Behav. 2004 Sep;29(7):1427-37. doi: 10.1016/j.addbeh.2004.06.013. Addict Behav. 2004. PMID: 15345274 Review.
Cited by
-
Feasibility of a mail-in, self-administered dried blood spot collection method in national, population-based alcohol surveys in the United States.Addiction. 2019 Jul;114(7):1303-1308. doi: 10.1111/add.14603. Epub 2019 Apr 29. Addiction. 2019. PMID: 30889308 Free PMC article.
-
Cessation of alcohol consumption decreases rate of nicotine metabolism in male alcohol-dependent smokers.Drug Alcohol Depend. 2016 Jun 1;163:157-64. doi: 10.1016/j.drugalcdep.2016.04.006. Epub 2016 Apr 14. Drug Alcohol Depend. 2016. PMID: 27107849 Free PMC article. Clinical Trial.
-
Focus on alcoholic liver disease: from nosography to treatment.World J Gastroenterol. 2014 Jul 7;20(25):8040-7. doi: 10.3748/wjg.v20.i25.8040. World J Gastroenterol. 2014. PMID: 25009375 Free PMC article. Review.
-
Ethanol consumption: how should we measure it? Achieving consilience between human and animal phenotypes.Addict Biol. 2010 Apr;15(2):109-24. doi: 10.1111/j.1369-1600.2009.00192.x. Addict Biol. 2010. PMID: 20148775 Free PMC article. Review.
-
Estimating driver risk using alcohol biomarkers, interlock blood alcohol concentration tests and psychometric assessments: initial descriptives.Addiction. 2010 Feb;105(2):226-39. doi: 10.1111/j.1360-0443.2009.02738.x. Epub 2009 Nov 16. Addiction. 2010. PMID: 19922520 Free PMC article.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Medical
