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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03758274
Other study ID # RSRB00072850
Secondary ID R01AA026815-01
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date July 21, 2022

Study information

Verified date October 2023
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A small percentage of individuals with alcohol use disorder (AUD) obtain alcohol-related care despite research showing that treatment is effective. This randomized controlled trial tests the efficacy of a brief, phone based cognitive behavioral intervention to increase treatment engagement, improve alcohol related outcomes, and show that treatment engagement is a mechanism for the improved outcomes in individuals with AUD.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date July 21, 2022
Est. primary completion date July 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age 18-plus; - score = 16 on AUDIT; - within the past 30 days, exceeding the limits for low-risk drinking adopted by NIAAA: >3 standard drinks on any occasion or >7 drinks per week (women); >4 drinks on any occasion or >14 drinks per week (men). Exclusion Criteria: - unable to communicate with the researcher in English; - unable to comprehend the nature of the study; - history of alcohol-related care; - alcohol withdrawal necessitating medical evaluation; - residency outside of The Greater Rochester Area.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CBT by Phone to Promote Treatment
Structured phone intervention to identify concerns about getting alcohol use disorder treatment and to work through those concerns using cognitive behavioral principles.
Other:
Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment
The pamphlet was created by the National Institute on Alcohol Abuse and Alcoholism to describe evidence based treatments available for alcohol use disorder and how to obtain such treatment.

Locations

Country Name City State
United States University of Rochester Rochester New York

Sponsors (4)

Lead Sponsor Collaborator
University of Rochester Medical University of South Carolina, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Syracuse University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average Drinks Per Drinking Day Average number of standard drinks on days of alcohol consumption at 3-month follow-up prior 30 days (at 3-month follow-up)
Primary Days Abstinent Number of days abstinent from alcohol use in prior 30 days prior 30 days (at 3-month follow-up)
Primary Number Initiating Alcohol Use Disorder Treatment Number Attending any Alcohol Use Disorder Treatment Session(s) over 3-month follow-up over 3 months
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