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.
|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|