- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00855699
Alcohol Detoxification in Primary Care Treatment (ADEPT) (ADEPT)
Alcohol Detoxification in Primary Care Treatment (ADEPT) - a Feasibility Study of Conducting a Randomised Trial in Primary Care Comparing Two Pharmacological Regimens.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Bristol, United Kingdom, BS6 6JL
- University of Bristol, Bristol PCT.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in alcohol withdrawal symptoms
Time Frame: up to 10 days
|
up to 10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
alcohol drinking
Time Frame: within 4 weeks of end of detox
|
within 4 weeks of end of detox
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Lingford-Hughes, University of Bristol
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RED 740
- RfPB: PB-PG-0407-13296
- EUDRACT: 2008-004820-22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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