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Completed

NCT Number: NCT00855699

Alcohol Detoxification in Primary Care Treatment (ADEPT)

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).

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Bristol, Bristol PCT.

Bristol, BS6 6JL, United Kingdom

About this study

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:

  • determine the optimal method of recruiting patients in primary care and estimate likely recruitment rate
  • 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.
  • investigate patient and GP acceptability of this randomised trial using qualitative measures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Anyone (18-65 years old) consulting their GP for whom a community based alcohol detox requiring medication is appropriate.
  • Due to acamprosate's license for maintaining abstinence, nobody under the age of 18 and over 65 will be recruited.

Exclusion criteria

  • Unsuitable for home/community detox, e.g., with current or significant history of:
  • delirium tremens or seizures
  • current or history of high dose polydrug use
  • significant medical or psychiatric ill health
  • pregnant or breast feeding
  • Wernicke's encephalopathy

Treatment and study plan

acamprosate

Drug

Acamprosate 333mg tablets, two tablets three times a day for duration of alcohol detox.

Other names: Campral

Primary outcomes

  1. Reduction in alcohol withdrawal symptoms

    Time frame: up to 10 days

Secondary outcomes

  1. alcohol drinking

    Time frame: within 4 weeks of end of detox

Sponsors and collaborators

Lead sponsor

University of Bristol

Other

Registry information

Official study title

Alcohol Detoxification in Primary Care Treatment (ADEPT) - a Feasibility Study of Conducting a Randomised Trial in Primary Care Comparing Two Pharmacological Regimens.

Acronym: ADEPT

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 4, 2009
Registry last updated
Jan 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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