Treatment Settings for Those With an Alcohol Problem

October 8, 2020 updated by: Robert Rychtarik, State University of New York at Buffalo

Treatment Settings for Alcoholics: A Field Extension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Inpatient Care + Needs Inpatient
Individuals with high alcohol involvement or low cognitive functioning receiving inpatient treatment
Behavioral: Inpatient Care
21 days of inpatient substance misuse treatment
Active Comparator: Inpatient Care + No Need for Inpatient
Individuals with low alcohol involvement or mid-high cognitive functioning receiving inpatient treatment
Behavioral: Inpatient Care
21 days of inpatient substance misuse treatment
Active Comparator: Outpatient Care + Needs Inpatient
Individuals with high alcohol involvement or low cognitive functioning receiving outpatient treatment
Behavioral: Outpatient Care
21 days of outpatient substance misuse treatment
Active Comparator: Outpatient Care + No Need for Inpatient
Individuals with low alcohol involvement and or mid-high cognitive functioning receiving outpatient treatment
Behavioral: Outpatient Care
21 days of outpatient substance misuse treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monthly Percentage of Voluntary Abstinent Days (from Timeline Followback Interview)
Time Frame: Change up to 18 months
Percentage of Days Abstinent of those in which drinking was not restricted
Change up to 18 months
Monthly Point Prevalence of Abstinent Days (from Timeline Followback Interview)
Time Frame: Change up to 18 months
Monthly percentage of participants abstinent throughout a month
Change up to 18 months
Monthly Drinks per Drinking Day (from Timeline Followback Interview)
Time Frame: Change up to 18 months
For those drinking in a month, average drinks per drinking day
Change up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monthly percentage of Involuntary abstinent days (from Timeline Followback Interview)
Time Frame: Up to 18 months
Monthly percentage of days in which the participant was incarcerated, hospitalized, or in residential treatment
Up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

October 12, 2020

Last Update Submitted That Met QC Criteria

October 8, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA013625

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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