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Trial record 34 of 80 for:    ASNS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01060397
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : November 26, 2014
Information provided by (Responsible Party):
Dr Lynn Owens, Southport and Ormskirk Hospital NHS Trust

Brief Summary:

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 or disease Intervention/treatment Phase
Alcohol Dependence Behavioral: Extended Brief Intervention Behavioral: Control Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Extended Brief Interventions for Alcohol-dependent Patients in an Acute Care Setting
Study Start Date : November 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Extended Brief Intervention
FRAMES motivational interviewing approach
Behavioral: Extended Brief Intervention
Frames motivational interviewing approach

Experimental: Control
Usual care
Behavioral: Control
Usual care

Primary Outcome Measures :
  1. Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: Baseline, twelve weeks and six months ]

Secondary Outcome Measures :
  1. Measure of Dependence (Leeds Dependency Questionnaire) [ Time Frame: baseline, 12 weeks and 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01060397

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United Kingdom
Southport and Ormskirk NHS Trust
Southport, England, United Kingdom, L39 2AZ
Sponsors and Collaborators
Southport and Ormskirk Hospital NHS Trust
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Study Chair: Munir Pirmohamed, PhD FRCP The University of Liverpool

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Responsible Party: Dr Lynn Owens, Southport and Ormskirk Hospital NHS Trust Identifier: NCT01060397     History of Changes
Other Study ID Numbers: PB-PG-0408-15077
NIHR CRN study ID 7889 ( Other Grant/Funding Number: NIHR Clinical Research Network )
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: January 2010
Keywords provided by Dr Lynn Owens, Southport and Ormskirk Hospital NHS Trust:
alcohol dependence
acute hospital
brief interventions
Additional relevant MeSH terms:
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Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs