Alcohol Detoxification in Primary Care Treatment (ADEPT)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Alcohol Detoxification in Primary Care Treatment (ADEPT) - a Feasibility Study of Conducting a Randomised Trial in Primary Care Comparing Two Pharmacological Regimens.|
- Reduction in alcohol withdrawal symptoms [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
- alcohol drinking [ Time Frame: within 4 weeks of end of detox ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||November 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855699
|University of Bristol, Bristol PCT.|
|Bristol, United Kingdom, BS6 6JL|
|Principal Investigator:||Anne Lingford-Hughes||University of Bristol|