Alcohol Detoxification in Primary Care Treatment (ADEPT) (ADEPT)

• ClinicalTrials.gov Identifier: NCT00855699
• Recruitment Status: Completed
• First Posted: March 4, 2009
• Last Update Posted: January 19, 2011
• Sponsor: University of Bristol
• Information provided by: University of Bristol

Tracking Information

• First Submitted Date: March 3, 2009
• First Posted Date: March 4, 2009
• Last Update Posted Date: January 19, 2011
• Study Start Date: November 2009
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 3, 2009): Reduction in alcohol withdrawal symptoms [ Time Frame: up to 10 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: March 3, 2009): alcohol drinking [ Time Frame: within 4 weeks of end of detox ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Alcohol Detoxification in Primary Care Treatment (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.
• 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:

1. determine the optimal method of recruiting patients in primary care and estimate likely recruitment rate
2. 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.
3. investigate patient and GP acceptability of this randomised trial using qualitative measures.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Alcoholism

Intervention

Drug: Acamprosate

Acamprosate 333mg tablets, two tablets three times a day for duration of alcohol detox.

Other Name: Campral

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 18, 2011): 36
• Original Estimated Enrollment (submitted: March 3, 2009): 60
• Actual Study Completion Date: November 2010
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00855699
• Other Study ID Numbers: RED 740; RfPB: PB-PG-0407-13296; EUDRACT: 2008-004820-22
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dr Anne Lingford-Hughes, University of Bristol
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Bristol
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Anne Lingford-Hughes; University of Bristol

• PRS Account: University of Bristol
• Verification Date: January 2011