Alcohol Detoxification in Primary Care Treatment (ADEPT)
Information source: University of Bristol
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Dependence
Intervention: Acamprosate (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Bristol Overall contact:
Anne R Lingford-Hughes, MD PhD, Phone: +44 117 954 6784, Email: anne.lingford-hughes@bristol.ac.uk
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).
Clinical Details
Official title: Alcohol Detoxification in Primary Care Treatment (ADEPT) - a Feasibility Study of Conducting a Randomised Trial in Primary Care Comparing Two Pharmacological Regimens.
Study design: Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Reduction in alcohol withdrawal symptoms
Secondary outcome: alcohol drinking
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Anne R Lingford-Hughes, MD PhD, Phone: +44 117 954 6784, Email: anne.lingford-hughes@bristol.ac.uk
University of Bristol, Bristol PCT., Bristol BS6 6JL, United Kingdom; Recruiting
Anne Lingford-Hughes, Email: Anne.Lingford-Hughes@bristol.ac.uk
Karen Alloway, Email: Karen.Alloway@bristol.ac.uk
Anne R Lingford-Hughes, MD PhD, Principal Investigator
Additional Information
Starting date: November 2009
Last updated: June 30, 2010
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