Acamprosate is approved by the Food and Drug Administration (FDA) for the treatment of alcoholism. The purpose of this study is to see if initiating acamprosate early in alcohol detoxification instead of waiting until detoxification has been completed effects the course of detoxification, adverse events during detoxification, drop out rate during the rehabilitative treatment phase, or overall efficacy of acamprosate for those with alcohol dependence who plan to receive at least two months of rehabilitative pharmacotherapy with acamprosate.
Biphasic clinical trial, consisting of a randomized, double-blind, placebo-controlled detoxification treatment phase (DP), followed by 9-week open-label rehabilitative treatment phase (RP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
3 pills (666 mg) for 1998mg/day
3 pills (666mg) for 1998mg/day
Treatment Research Center
Philadelphia, Pennsylvania, United States
1) the mean number of adverse events rated moderate to severe;
Time frame: Phase I: up to 2 weeks
2) the week of detoxification treatment discontinuation;
Time frame: Phase I: up to 2 weeks
3) the total amount of oxazepam given;
Time frame: Phase I: up to 2 weeks
4) the rate of change in CIWA scores.
Time frame: Phase I: up to 2 weeks
1) the mean number of adverse events rated moderate to severe;
Time frame: Phase II: 10 weeks
2) the week of open-label treatment discontinuation;
Time frame: Phase II: 10 weeks
3) any reemergence of detoxification symptoms;
Time frame: Phase II: 10 weeks
4) % pills taken over what was proposed to be prescribed (medication exposure);
Time frame: Phase II: 10 weeks
5) % days abstinent;
Time frame: Phase II: 10 weeks
6) % days heavy drinking.
Time frame: Phase II: 10 weeks
Changes in alcohol craving will be measured by Penn Alcohol Craving Scale (PACS; Flannery et al, 1999)
Time frame: 12 weeks
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Changes in anxiety symptoms will be measured by the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A; Hamilton, 1969)
Time frame: 12 weeks
Changes in depressive symptoms will be measured by the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D; Hamilton 1967)
Time frame: 12 weeks
Changes in social functioning will be measured by several of the subscales of the Addiction Severity Index (ASI; McLellan et al, 1992); namely, medical, legal, psychiatric, and family/social.
Time frame: 12 weeks
Quality of Life, measured by the Short Form-36 Health Status Questionnaire (SF-36; Ware & Sherbourne, 1999)
Time frame: 12 weeks
Overall clinical impression of improvement will be measured by the Clinical Global Impression Scale (CGI)
Time frame: 12 weeks