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Treatment Settings for Those With an Alcohol Problem

Primary Purpose

Alcohol Abuse, Alcohol-dependence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inpatient Care
Outpatient Care
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eligible for treatment through the Chemical Dependency treatment programs of a large, community-based healthcare network
  • Drank alcoholic beverages within the last 90 days
  • Have a current address (not homeless)
  • Free of legal stipulations that would affect treatment decisions
  • Have a past 3 months Alcohol Use Disorder
  • Primary alcohol, or alcohol and drug problem

Exclusion Criteria:

  • Homeless
  • Drug problem only

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Inpatient Care + Needs Inpatient

    Inpatient Care + No Need for Inpatient

    Outpatient Care + Needs Inpatient

    Outpatient Care + No Need for Inpatient

    Arm Description

    Individuals with high alcohol involvement or low cognitive functioning receiving inpatient treatment

    Individuals with low alcohol involvement or mid-high cognitive functioning receiving inpatient treatment

    Individuals with high alcohol involvement or low cognitive functioning receiving outpatient treatment

    Individuals with low alcohol involvement and or mid-high cognitive functioning receiving outpatient treatment

    Outcomes

    Primary Outcome Measures

    Monthly Percentage of Voluntary Abstinent Days (from Timeline Followback Interview)
    Percentage of Days Abstinent of those in which drinking was not restricted
    Monthly Point Prevalence of Abstinent Days (from Timeline Followback Interview)
    Monthly percentage of participants abstinent throughout a month
    Monthly Drinks per Drinking Day (from Timeline Followback Interview)
    For those drinking in a month, average drinks per drinking day

    Secondary Outcome Measures

    Monthly percentage of Involuntary abstinent days (from Timeline Followback Interview)
    Monthly percentage of days in which the participant was incarcerated, hospitalized, or in residential treatment

    Full Information

    First Posted
    December 6, 2016
    Last Updated
    October 8, 2020
    Sponsor
    State University of New York at Buffalo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02986776
    Brief Title
    Treatment Settings for Those With an Alcohol Problem
    Official Title
    Treatment Settings for Alcoholics: A Field Extension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2002 (undefined)
    Primary Completion Date
    April 2008 (Actual)
    Study Completion Date
    April 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    State University of New York at Buffalo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A prior study in a tightly controlled clinical research environment found individuals with an alcohol use disorder (AUD) benefited more from inpatient (IP) than outpatient (OP) care, if they presented with high alcohol involvement and/or low cognitive functioning. This study sought to: (a) validate and extend these findings within the uncontrolled environment of a community-based treatment center, and (b) test whether inpatients had fewer days of involuntary abstinence (e.g., incarcerations) relative to outpatients. Based on their need for inpatient treatment, using prior cut-points for alcohol involvement and cognitive functioning, participants were randomly assigned within inpatient need group (No Need for IP; Needs IP) to either 21-days of inpatient substance misuse treatment or 21-days of outpatient treatment, all followed by 6 months of continuing outpatient care. Follow-up were conducted an 90-day intervals across 18 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Abuse, Alcohol-dependence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    176 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Inpatient Care + Needs Inpatient
    Arm Type
    Active Comparator
    Arm Description
    Individuals with high alcohol involvement or low cognitive functioning receiving inpatient treatment
    Arm Title
    Inpatient Care + No Need for Inpatient
    Arm Type
    Active Comparator
    Arm Description
    Individuals with low alcohol involvement or mid-high cognitive functioning receiving inpatient treatment
    Arm Title
    Outpatient Care + Needs Inpatient
    Arm Type
    Active Comparator
    Arm Description
    Individuals with high alcohol involvement or low cognitive functioning receiving outpatient treatment
    Arm Title
    Outpatient Care + No Need for Inpatient
    Arm Type
    Active Comparator
    Arm Description
    Individuals with low alcohol involvement and or mid-high cognitive functioning receiving outpatient treatment
    Intervention Type
    Behavioral
    Intervention Name(s)
    Inpatient Care
    Intervention Description
    21 days of inpatient substance misuse treatment
    Intervention Type
    Behavioral
    Intervention Name(s)
    Outpatient Care
    Intervention Description
    21 days of outpatient substance misuse treatment
    Primary Outcome Measure Information:
    Title
    Monthly Percentage of Voluntary Abstinent Days (from Timeline Followback Interview)
    Description
    Percentage of Days Abstinent of those in which drinking was not restricted
    Time Frame
    Change up to 18 months
    Title
    Monthly Point Prevalence of Abstinent Days (from Timeline Followback Interview)
    Description
    Monthly percentage of participants abstinent throughout a month
    Time Frame
    Change up to 18 months
    Title
    Monthly Drinks per Drinking Day (from Timeline Followback Interview)
    Description
    For those drinking in a month, average drinks per drinking day
    Time Frame
    Change up to 18 months
    Secondary Outcome Measure Information:
    Title
    Monthly percentage of Involuntary abstinent days (from Timeline Followback Interview)
    Description
    Monthly percentage of days in which the participant was incarcerated, hospitalized, or in residential treatment
    Time Frame
    Up to 18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Eligible for treatment through the Chemical Dependency treatment programs of a large, community-based healthcare network Drank alcoholic beverages within the last 90 days Have a current address (not homeless) Free of legal stipulations that would affect treatment decisions Have a past 3 months Alcohol Use Disorder Primary alcohol, or alcohol and drug problem Exclusion Criteria: Homeless Drug problem only

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28150955
    Citation
    Rychtarik RG, McGillicuddy NB, Papandonatos GD, Whitney RB, Connors GJ. Randomized clinical trial of matching client alcohol use disorder severity and level of cognitive functioning to treatment setting: A partial replication and extension. Psychol Addict Behav. 2017 Aug;31(5):513-523. doi: 10.1037/adb0000253. Epub 2017 Feb 2.
    Results Reference
    derived

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    Treatment Settings for Those With an Alcohol Problem

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