Alcohol Detoxification in Primary Care Treatment (ADEPT)
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      Once someone becomes dependent on alcohol (alcoholic), the risks of complications from
      alcohol withdrawal when they stop drinking grow. These can include a life-threatening fit or
      delirium tremens (see things, become frightened). To prevent such complications, people take
      medication such as benzodiazepines (e.g., valium or librium) in reducing doses for about a
      week; this is called detoxification or 'detox.' In the UK effective alcohol treatment exists
      but little is known about what is the best detox medication. Alternative drugs to
      benzodiazepines appear to protect the brain from the toxicity of alcohol withdrawal and to
      reduce the likelihood of drinking again. This study will examine the feasibility of comparing
      medication regimens for alcohol detox for the first time in primary care. It will include a
      standard detox regimen (librium over 8 days) alone and together with a drug, acamprosate,
      that has been shown to reduce toxicity of alcohol withdrawal in preclinical models and is
      used after detox to help people remain sober. It will focus on the practicalities of doing
      such a study as well as assessing how people feel (withdrawal symptoms) and do (drinking
      during first month).
    

Detailed description: 
      Aims and objectives:

      To provide a framework for investigating the hypothesis that for those patients undergoing
      alcohol detox in primary care adding acamprosate to a reducing regimen of a benzodiazepine
      (chlordiazepoxide) provides better symptom control during detox compared with benzodiazepine
      alone. In addition we will assess improvement in sleep, drinking outcomes, completion rates
      and cognitive performance.

      Specific primary aim:

      This feasibility study aims to inform a full application for an RCT to compare the
      effectiveness and cost-effectiveness of acamprosate as an adjunctive treatment for
      benzodiazepines for alcohol detox in primary care.

      Key objectives are to:

        1. determine the optimal method of recruiting patients in primary care and estimate likely
           recruitment rate

        2. investigate feasibility of completion of and variation in our proposed primary outcome
           measure in the community - Clinical Institute of Withdrawal Scale-Alcohol (symptoms
           during detox), and secondary outcome measures - drinking during first month (via diary
           to derive % days abstinent), completion of detox, sleep and cognitive performance.

        3. investigate patient and GP acceptability of this randomised trial using qualitative
           measures.
    

Intervention name(s): Acamprosate
Intervention type(s): Drug
Intervention description(s): Acamprosate 333mg tablets, two tablets three times a day for duration of alcohol detox.
Other intervention name(s): Campral
Intervention MeSH terms: Acamprosate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol detoxification