Alcohol Detoxification in Primary Care Treatment (ADEPT) (ADEPT)
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|ClinicalTrials.gov Identifier: NCT00855699|
Recruitment Status : Completed
First Posted : March 4, 2009
Last Update Posted : January 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism||Drug: Acamprosate||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||November 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||November 2010|
- Drug: Acamprosate
Acamprosate 333mg tablets, two tablets three times a day for duration of alcohol detox.Other Name: Campral
- Reduction in alcohol withdrawal symptoms [ Time Frame: up to 10 days ]
- alcohol drinking [ Time Frame: within 4 weeks of end of detox ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855699
|University of Bristol, Bristol PCT.|
|Bristol, United Kingdom, BS6 6JL|
|Principal Investigator:||Anne Lingford-Hughes||University of Bristol|