NCT02986776

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2002

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
Last Updated

October 12, 2020

Status Verified

October 1, 2020

Enrollment Period

5.7 years

First QC Date

December 6, 2016

Last Update Submit

October 8, 2020

Conditions

Alcohol AbuseAlcohol-dependence

Outcome Measures

Primary Outcomes (3)

  • Monthly Percentage of Voluntary Abstinent Days (from Timeline Followback Interview)

    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)

    Monthly percentage of participants abstinent throughout a month

    Change up to 18 months

  • Monthly Drinks per Drinking Day (from Timeline Followback Interview)

    For those drinking in a month, average drinks per drinking day

    Change up to 18 months

Secondary Outcomes (1)

  • Monthly percentage of Involuntary abstinent days (from Timeline Followback Interview)

    Up to 18 months

Study Arms (4)

Inpatient Care + Needs Inpatient

ACTIVE COMPARATOR

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

Behavioral: Inpatient Care

Inpatient Care + No Need for Inpatient

ACTIVE COMPARATOR

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

Behavioral: Inpatient Care

Outpatient Care + Needs Inpatient

ACTIVE COMPARATOR

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

Behavioral: Outpatient Care

Outpatient Care + No Need for Inpatient

ACTIVE COMPARATOR

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

Behavioral: Outpatient Care

Interventions

Inpatient CareBEHAVIORAL

21 days of inpatient substance misuse treatment

Inpatient Care + Needs InpatientInpatient Care + No Need for Inpatient
Outpatient CareBEHAVIORAL

21 days of outpatient substance misuse treatment

Outpatient Care + Needs InpatientOutpatient Care + No Need for Inpatient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Homeless
  • Drug problem only

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28150955DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

HospitalizationAmbulatory Care

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 8, 2016

Study Start

August 1, 2002

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

October 12, 2020

Record last verified: 2020-10