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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02986776
Other study ID # AA013625
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2002
Est. completion date April 2008

Study information

Verified date October 2020
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 176
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Inpatient Care
21 days of inpatient substance misuse treatment
Outpatient Care
21 days of outpatient substance misuse treatment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
State University of New York at Buffalo

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Monthly Point Prevalence of Abstinent Days (from Timeline Followback Interview) Monthly percentage of participants abstinent throughout a month Change up to 18 months
Primary 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 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 Up to 18 months
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