Alcohol Detoxification in Primary Care Treatment (ADEPT) - Full Text View

Sponsor:	University of Bristol
Information provided by:	University of Bristol
ClinicalTrials.gov Identifier:	NCT00855699

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
Alcohol Dependence	Drug: Acamprosate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
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:

MedlinePlus related topics: Alcoholism

Drug Information available for: Ethanol Acamprosate calcium Acamprosate

U.S. FDA Resources

Further study details as provided by University of Bristol:

Primary Outcome Measures:

Reduction in alcohol withdrawal symptoms [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

alcohol drinking [ Time Frame: within 4 weeks of end of detox ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	November 2009
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

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:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855699

Contacts

Contact: Anne R Lingford-Hughes, MD PhD

+44 117 954 6784

anne.lingford-hughes@bristol.ac.uk

Locations

United Kingdom
University of Bristol, Bristol PCT.	Recruiting
Bristol, United Kingdom, BS6 6JL
Contact: Anne Lingford-Hughes Anne.Lingford-Hughes@bristol.ac.uk
Contact: Karen Alloway Karen.Alloway@bristol.ac.uk
Principal Investigator: Anne R Lingford-Hughes, MD PhD

Sponsors and Collaborators

University of Bristol

More Information

No publications provided

Responsible Party:	University of Bristol ( Dr Anne Lingford-Hughes )
Study ID Numbers:	RED 740, RfPB: PB-PG-0407-13296, EUDRACT: 2008-004820-22
Study First Received:	March 3, 2009
Last Updated:	January 11, 2010
ClinicalTrials.gov Identifier:	NCT00855699 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee

Keywords provided by University of Bristol:

Alcohol detoxification

Additional relevant MeSH terms:

Mental Disorders
Therapeutic Uses
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin

Alcohol-Related Disorders
Central Nervous System Agents
Pharmacologic Actions
Alcohol Deterrents
Acamprosate

ClinicalTrials.gov processed this record on February 08, 2010