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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
Information provided by:
University of Bristol

Tracking Information
First Submitted Date  ICMJE March 3, 2009
First Posted Date  ICMJE March 4, 2009
Last Update Posted Date January 19, 2011
Study Start Date  ICMJE November 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2009)
Reduction in alcohol withdrawal symptoms [ Time Frame: up to 10 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2009)
alcohol drinking [ Time Frame: within 4 weeks of end of detox ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Alcohol Detoxification in Primary Care Treatment (ADEPT)
Official Title  ICMJE Alcohol Detoxification in Primary Care Treatment (ADEPT) - a Feasibility Study of Conducting a Randomised Trial in Primary Care Comparing Two Pharmacological Regimens.
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcoholism
Intervention  ICMJE Drug: Acamprosate
Acamprosate 333mg tablets, two tablets three times a day for duration of alcohol detox.
Other Name: Campral
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2011)
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2009)
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00855699
Other Study ID Numbers  ICMJE RED 740
RfPB: PB-PG-0407-13296
EUDRACT: 2008-004820-22
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr Anne Lingford-Hughes, University of Bristol
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Bristol
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne Lingford-Hughes University of Bristol
PRS Account University of Bristol
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP