Alcohol Detoxification in Primary Care Treatment (ADEPT)

NCT ID: NCT00855699

Last Updated: 2011-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-11-30

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.

Conditions

Alcoholism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

Acamprosate

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

Intervention Type: DRUG

Other Intervention Names

Campral

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bristol

OTHER

Sponsor Role: lead

Responsible Party

University of Bristol

Principal Investigators

Anne Lingford-Hughes

Role: PRINCIPAL_INVESTIGATOR

University of Bristol

Locations

University of Bristol, Bristol PCT.

Bristol, , United Kingdom

Countries

United Kingdom

Other Identifiers

RfPB: PB-PG-0407-13296

Identifier Type: -

Identifier Source: secondary_id

EUDRACT: 2008-004820-22

Identifier Type: -

Identifier Source: secondary_id

RED 740

Identifier Type: -

Identifier Source: org_study_id