Alcohol Detoxification in Primary Care Treatment (ADEPT) (ADEPT)
Primary Purpose
Alcoholism
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Acamprosate
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism focused on measuring Alcohol detoxification
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
Sites / Locations
- University of Bristol, Bristol PCT.
Outcomes
Primary Outcome Measures
Reduction in alcohol withdrawal symptoms
Secondary Outcome Measures
alcohol drinking
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00855699
Brief Title
Alcohol Detoxification in Primary Care Treatment (ADEPT)
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bristol
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Alcohol detoxification
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Acamprosate
Other Intervention Name(s)
Campral
Intervention Description
Acamprosate 333mg tablets, two tablets three times a day for duration of alcohol detox.
Primary Outcome Measure Information:
Title
Reduction in alcohol withdrawal symptoms
Time Frame
up to 10 days
Secondary Outcome Measure Information:
Title
alcohol drinking
Time Frame
within 4 weeks of end of detox
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Lingford-Hughes
Organizational Affiliation
University of Bristol
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bristol, Bristol PCT.
City
Bristol
ZIP/Postal Code
BS6 6JL
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Alcohol Detoxification in Primary Care Treatment (ADEPT)
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