Alcohol Detoxification in Primary Care Treatment (ADEPT)
ADEPT
3 other identifiers
interventional
36
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2009
CompletedFirst Posted
Study publicly available on registry
March 4, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJanuary 19, 2011
January 1, 2011
8 months
March 3, 2009
January 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in alcohol withdrawal symptoms
up to 10 days
Secondary Outcomes (1)
alcohol drinking
within 4 weeks of end of detox
Interventions
Acamprosate 333mg tablets, two tablets three times a day for duration of alcohol detox.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Bristol, Bristol PCT.
Bristol, BS6 6JL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Lingford-Hughes
University of Bristol
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 3, 2009
First Posted
March 4, 2009
Study Start
November 1, 2009
Primary Completion
July 1, 2010
Study Completion
November 1, 2010
Last Updated
January 19, 2011
Record last verified: 2011-01