Alcohol Detoxification in Primary Care Treatment (ADEPT)

Alcoholism Clinical Trial

— ADEPT  

Official title:

Alcohol Detoxification in Primary Care Treatment (ADEPT) - a Feasibility Study of Conducting a Randomised Trial in Primary Care Comparing Two Pharmacological Regimens.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855699
• Other study ID #: RED 740
• Secondary ID: RfPB: PB-PG-0407
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2009
• Last updated: January 18, 2011
• Start date: November 2009
• Est. completion date: November 2010

Study information

• Verified date: January 2011
• Source: University of Bristol
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Bristol, Bristol PCT.	Bristol

Sponsors (1)

Lead Sponsor	Collaborator
University of Bristol

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in alcohol withdrawal symptoms		up to 10 days	No
Secondary	alcohol drinking		within 4 weeks of end of detox	No