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
About this trial
This is an interventional treatment trial for Alcohol Abuse
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
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
NCT ID
NCT02986776
First Posted
December 6, 2016
Last Updated
October 8, 2020
Sponsor
State University of New York at Buffalo
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
Learn more about this trial
Treatment Settings for Those With an Alcohol Problem
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