Acamprosate Initiated During Alcohol Detoxification
- Registration Number
- NCT00360594
- Lead Sponsor
- Forest Laboratories
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo Placebo 1 Acamprosate Acamprosate
- Primary Outcome Measures
Name Time Method 6) % days heavy drinking. Phase II: 10 weeks 5) % days abstinent; Phase II: 10 weeks 1) the mean number of adverse events rated moderate to severe; Phase II: 10 weeks 2) the week of detoxification treatment discontinuation; Phase I: up to 2 weeks 4) % pills taken over what was proposed to be prescribed (medication exposure); Phase II: 10 weeks 3) the total amount of oxazepam given; Phase I: up to 2 weeks 4) the rate of change in CIWA scores. Phase I: up to 2 weeks 2) the week of open-label treatment discontinuation; Phase II: 10 weeks 3) any reemergence of detoxification symptoms; Phase II: 10 weeks
- Secondary Outcome Measures
Name Time Method Changes in alcohol craving will be measured by Penn Alcohol Craving Scale (PACS; Flannery et al, 1999) 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. 12 weeks Changes in depressive symptoms will be measured by the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D; Hamilton 1967) 12 weeks Quality of Life, measured by the Short Form-36 Health Status Questionnaire (SF-36; Ware & Sherbourne, 1999) 12 weeks Changes in anxiety symptoms will be measured by the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A; Hamilton, 1969) 12 weeks Overall clinical impression of improvement will be measured by the Clinical Global Impression Scale (CGI) 12 weeks
Trial Locations
- Locations (1)
Treatment Research Center
🇺🇸Philadelphia, Pennsylvania, United States