A Controlled Trial of Extended Brief Interventions in Alcohol Dependent Patients (ADPAC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Southport and Ormskirk Hospital NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Southport and Ormskirk Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT01060397
First received: February 1, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

Heavy alcohol consumption leads to various health problems and is now recognised to be an important public health problem. This is evidenced by the huge media attention recently focused on the use and misuse of alcohol, particularly by younger patients. At least 1 in 20 of the population in the UK are physically and psychologically dependent on alcohol. This not only has consequences for the physical and psychological well-being of these patients, but has adverse consequences for their family, work life and society in general. Current treatments are mostly delivered in specialist units, which are few in number meaning that few patients get access to these services. This leads to a vicious cycle which results in multiple hospital admissions, ineffective treatments and continual drinking. It is therefore vital the investigators develop alternative effective treatments for these patients which can interrupt this vicious cycle.

In patients who drink heavily, but are not yet alcohol-dependent, a treatment called brief intervention can help reduce overall alcohol consumption, and improve health and wellbeing. However, whether a similar intervention can help alcohol-dependent patients has not yet been established.

In this study, the investigators aim to identify, treat and support alcohol-dependent individuals. Using an enhanced form of BI (termed extended brief intervention, EBI) as the basis of clinical care, the investigators will undertake a randomised trial comparing EBI with usual clinical care. The investigators will use various clinical and behavioural measures to assess the effectiveness of this treatment. The investigators will also be asking patients how they felt, and what they think of their treatment and the professionals delivering that treatment. If EBI is shown to be effective and is not too costly, it could provide a national framework for treatment of alcohol-dependent patients. This could potentially improve both the opportunities to access treatment and the choice of treatments available to patients.

The investigators hypothesis is that Extended Brief Interventions (EBI) delivered to alcohol-dependent patients in a hospital setting by an Alcohol Specialist Nurse (ASN) will be effective in reducing overall alcohol consumption and improving the standard measures of alcohol dependence.


Condition Intervention Phase
Alcohol Dependence
Behavioral: Extended Brief Intervention
Behavioral: Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Extended Brief Interventions for Alcohol-dependent Patients in an Acute Care Setting

Resource links provided by NLM:


Further study details as provided by Southport and Ormskirk Hospital NHS Trust:

Primary Outcome Measures:
  • Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: Baseline, twelve weeks and six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure of Dependence (Leeds Dependency Questionnaire) [ Time Frame: baseline, 12 weeks and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: November 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extended Brief Intervention
FRAMES motivational interviewing approach
Behavioral: Extended Brief Intervention
Frames motivational interviewing approach
Experimental: Control
Usual care
Behavioral: Control
Usual care

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a score equal to or greater than 16 on the AUDIT screening tool.

Exclusion Criteria:

  • Patient's known to be intravenous drug abusers.
  • Patients unable to give informed consent.
  • Patients whose medical co-morbidity requires requiring frequent or long term hospital admission. These will include patients who are/have;

    • Comatose /unconscious
    • End Stage Chronic Liver Disease
    • Dementia
    • Congestive Cardiac Failure stage III or IV
    • Acute Pancreatitis
    • Head Injury with abnormalities on CT scan
    • Cerebral Vascular Accident (CVA)
    • Chronic Obstructive Pulmonary Disease (COPD)
    • Other chronic conditions where an admission of 1 month or more is required.
  • Patient's presently recruited to any other research trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060397

Contacts
Contact: Lynn Owens, PhD 0044 (0) 151 7955395 lynno@liv.ac.uk
Contact: Kathryn Cobain, PhD 0044 (0) 151 7955395 kcobain@liv.ac.uk

Locations
United Kingdom
Southport and Ormskirk NHS Trust Recruiting
Southport, England, United Kingdom, L39 2AZ
Contact: Beverly Harrison    0044(0)1695 656788    beverley.harrison@southportandormskirk.nhs.uk   
Contact: Josephine Short, BA    0044 (0) 1704704862    josephine.short@nhs.net   
Principal Investigator: Lynn Owens, PhD         
Sponsors and Collaborators
Southport and Ormskirk Hospital NHS Trust
Investigators
Study Chair: Munir Pirmohamed, PhD FRCP The University of Liverpool
  More Information

No publications provided

Responsible Party: Dr Lynn Owens Principle Investigator, The University of Liverpool
ClinicalTrials.gov Identifier: NCT01060397     History of Changes
Other Study ID Numbers: PB-PG-0408-15077, NIHR CRN study ID 7889
Study First Received: February 1, 2010
Last Updated: February 1, 2010
Health Authority: United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by Southport and Ormskirk Hospital NHS Trust:
Alcohol
nurse
alcohol dependence
acute hospital
brief interventions

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014