We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00855699
First Posted: March 4, 2009
Last Update Posted: January 19, 2011
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.
Information provided by:
University of Bristol
  Purpose
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 Intervention Phase
Alcoholism Drug: Acamprosate Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Bristol:

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

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

Enrollment: 36
Study Start Date: November 2009
Study Completion Date: November 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Acamprosate
    Acamprosate 333mg tablets, two tablets three times a day for duration of alcohol detox.
    Other Name: Campral
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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
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
United Kingdom
University of Bristol, Bristol PCT.
Bristol, United Kingdom, BS6 6JL
Sponsors and Collaborators
University of Bristol
Investigators
Principal Investigator: Anne Lingford-Hughes University of Bristol
  More Information

Responsible Party: Dr Anne Lingford-Hughes, University of Bristol
ClinicalTrials.gov Identifier: NCT00855699     History of Changes
Other Study ID Numbers: RED 740
RfPB: PB-PG-0407-13296
EUDRACT: 2008-004820-22
First Submitted: March 3, 2009
First Posted: March 4, 2009
Last Update Posted: January 19, 2011
Last Verified: January 2011

Keywords provided by University of Bristol:
Alcohol detoxification

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Acamprosate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Alcohol Deterrents