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OpenTrials
Completed

NCT Number: NCT02084173

Treatment of Alcohol Problems in the Elderly

With the aging of western societies in the coming years combined with increasing alcohol consumption among elderly, the number of elderly with alcohol problems is expected to rise considerably.

Elderly patients are often lonely; suffer from feelings of loss, fear to be a burden on their children and on society, and feel powerless. On the surface their alcohol related problems seem less severe that those of the middle-aged patients while in reality co-morbidity and social issues complicate alcohol dependency.

Currently, no specific treatment tailored for alcohol use disorder among elderly is available. Consequently they receive either no treatment, are given brief advising from the general practitioner or are referred to treatment at specialized treatment institutions with no specific treatment for elderly.

The investigators propose a study aimed at developing and testing an outpatient behavior therapy program for alcohol use disorders for seniors (60 years and older), which - if effective - can be easily implemented in routine care. Three centers from Denmark, Germany and USA (New Mexico) will participate. All three centers have a long and extensive experience with alcohol treatment and alcohol research. Patients fulfilling the DSM 5 criteria for alcohol use disorder are eligible for the study.

After informed consent participants will be randomly assigned to either Motivational Enhancement Therapy (MET), four sessions/one session per week or MET followed by Community Re-enforcement Approach (CRA), eight sessions/one session per week - thus 12 weeks of treatment in total. 50% will receive MET and 50% MET+CRA. Primary outcome is percentage of patients with abstinence or controlled use (alcohol intake of equivalent blood alcohol content equal to or less than 0.5‰.). A total of 1000 patients will be enrolled. Participants will be assessed with a battery of international validated instruments measuring drinking pattern as well as key elements of treatment.

Participants are assessed before initiation of treatment, at the end of MET treatment (four weeks), at the end of MET+CRA treatment (12 weeks), at 6 months, and at 12 months.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit if Clinical Alcohol Research

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Seniors (+60 years) with alcohol use disorders according to DSM 5
  • Passing an "inclusion quiz" based on 10 questions pertaining to the implications of participating in the study, e.g. knowledge about that it is voluntary to participate, a person declining to participate will receive the standard treatment offered by the treatment clinic, an acceptance of participating can always be withdrawn. The quiz will be conducted after informed consent, and be in a multiple-choice format.

Exclusion criteria

  • We strive for ecological validity and will only exclude patients who are unable to participate in the therapy or are suffering from severe conditions judged to risking the validity of the study:
  • 7 or less correct answers in the "inclusion quiz" - indicating cognitive problems or not fully understanding the implications of participating in the study.
  • Psychotic disorder with positive and/or negative symptoms
  • Severe depression at time of inclusion
  • Bipolar disorder
  • Suicidal thoughts/behaviour at time of inclusion
  • Use of illicit opioids and/or illicit stimulants (all other forms of medication is allowed, including opioids on prescription - they will be recorded and may be included as covariates in the analyses)
  • Participating or have participated in other alcohol treatment programs within the last 30 days of inclusion. Pure detoxifications are not an exclusion criteria
  • Clients with legally authorized representatives

Treatment and study plan

MET + CRA

Behavioral

Other names: Motivational Enhancement Therapy (MET), with subsequent add-on The Community Reinforcement Approach (CRA)

Primary outcomes

  1. Alcohol consumption 26 weeks after baseline

    Time frame: 26 weeks after baseline

    Percentage of patients with abstinence or controlled use (daily alcohol intake equivalent to a BAC equal to or less than 0.5‰) in the last 30 days at 26 weeks after start of treatment. Measured by Form90

Secondary outcomes

  1. Abstinence or controlled use of alcohol

    Time frame: 4 weeks after baseline

    Percentage of patients with abstinence or controlled use (maximum daily alcohol intake of an equivalent of BAC 0.5‰)

    • In the last 7 days before planned termination of treatment (MET)
  2. Abstinence or controlled use of alcohol

    Time frame: 12 weeks after baseline

    Percentage of patients with abstinence or controlled use (maximum daily alcohol intake of an equivalent of BAC 0.5‰)

    • In the last 7 days before planned termination of MET + CRA
    • Participants in MET only, will also be measured
  3. Abstinence or controlled use of alcohol

    Time frame: 52 weeks after baseline

    Percentage of patients with abstinence or controlled use (maximum daily alcohol intake of an equivalent of BAC 0.5‰)

    • Since 26 weeks follow-up
    • In the last 30 days at 52 weeks follow-up

Other outcomes

  1. Changes in Quality of life

    Time frame: 52 weeks after baseline

    Quality of life measured by WHO QOL BREF and Personal Happiness Form

Sponsors and collaborators

Lead sponsor

Kjeld Andersen

Other

Collaborators

  • Addiction Research Unit, Technische Universität, Dresden, Germany
  • Institut für Therapieforschung, München, Germany
  • University of New Mexico

Registry information

Official study title

Motivational Enhancement Therapy and Community Reinforcement Approach For Treating Alcohol Problems in the Elderly

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 11, 2014
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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