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Alcohol Detoxification in Primary Care Treatment (ADEPT) (ADEPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00855699
Recruitment Status : Completed
First Posted : March 4, 2009
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:
University of Bristol

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Acamprosate Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alcohol Detoxification in Primary Care Treatment (ADEPT) - a Feasibility Study of Conducting a Randomised Trial in Primary Care Comparing Two Pharmacological Regimens.
Study Start Date : November 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: Acamprosate
    Acamprosate 333mg tablets, two tablets three times a day for duration of alcohol detox.
    Other Name: Campral

Outcome Measures
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Primary Outcome Measures :
  1. Reduction in alcohol withdrawal symptoms [ Time Frame: up to 10 days ]

Secondary Outcome Measures :
  1. alcohol drinking [ Time Frame: within 4 weeks of end of detox ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855699


Locations
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United Kingdom
University of Bristol, Bristol PCT.
Bristol, United Kingdom, BS6 6JL
Sponsors and Collaborators
University of Bristol
Investigators
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Principal Investigator: Anne Lingford-Hughes University of Bristol
More Information
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Responsible Party: Dr Anne Lingford-Hughes, University of Bristol
ClinicalTrials.gov Identifier: NCT00855699    
Other Study ID Numbers: RED 740
RfPB: PB-PG-0407-13296
EUDRACT: 2008-004820-22
First Posted: March 4, 2009    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 2011
Keywords provided by University of Bristol:
Alcohol detoxification
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
 Mental Disorders
Acamprosate
Alcohol Deterrents