This is a resubmission of an R21 proposal. This pilot study will compare the effectiveness of the lamotrigine and memantine to standard treatment of acute alcohol withdrawal and abstinence initiation in alcohol dependent patients, and the effect of these drugs on NDMA neurotransmission. A.
Specific Aim 1 : Are Memantine and Lamotrigine safe and effective detoxification strategies from alcohol in alcohol dependent individuals? 1. Do Lamotrigine and Memantine effectively treat the symptoms of alcohol withdrawal? 2. Do Lamotrigine and Memantine treat the emotional distress and depression associated with alcohol withdrawal in these patients? B.
Specific Aim 2 : Are Memantine and/or Lamotrigine effective in abstinence initiation and relapse prevention in the post-withdrawal (protracted withdrawal) phase in these individuals? 1. Are Memantine and/or Lamotrigine more effective than placebo in ameliorating depression, anxiety, and craving for alcohol in these patients? 2. Do Memantine and/or Lamotrigine prevent relapse to alcohol use more effectively than placebo in patients in the post-withdrawal (protracted withdrawal) phase ? Patients will be randomized to receive either memantine, lamotrigine, or a control strategy (Symptom Triggered Detoxification) (30 per group). All subjects will be recruited from the Leningrad Regional Center of Addictions affiliated with the St. Petersburg State PavIov Medical University (Russia). Only data analyses will be performed locally in New Haven. This pilot study will compare each active agent to placebo individually in order to evaluate these agents for a larger study. The primary outcomes are the number of patients successfully detoxified without additional benzodiazepine administered, Penn Alcohol Withdrawal Symptoms Checklist (PAWSC) and Clinical Institute Withdrawal Assessment Scale - Revised (CIWA-R) scores.

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21AA014543-03
Application #
7119249
Study Section
Health Services Research Review Subcommittee (AA)
Program Officer
Murray, Peggy
Project Start
2004-09-24
Project End
2008-08-31
Budget Start
2006-09-01
Budget End
2008-08-31
Support Year
3
Fiscal Year
2006
Total Cost
$77,681
Indirect Cost
Name
Yale University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
Krupitsky, Evgeny M; Rudenko, Anatoly A; Burakov, Andrey M et al. (2007) Antiglutamatergic strategies for ethanol detoxification: comparison with placebo and diazepam. Alcohol Clin Exp Res 31:604-11
Pittman, Brian; Gueorguieva, Ralitza; Krupitsky, Evgeny et al. (2007) Multidimensionality of the Alcohol Withdrawal Symptom Checklist: a factor analysis of the Alcohol Withdrawal Symptom Checklist and CIWA-Ar. Alcohol Clin Exp Res 31:612-8