NCT03758274

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 4, 2023

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

3.4 years

First QC Date

November 27, 2018

Results QC Date

July 13, 2023

Last Update Submit

October 3, 2023

Conditions

Alcohol Use DisorderAlcohol Abuse

Outcome Measures

Primary Outcomes (3)

  • 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)

  • Days Abstinent

    Number of days abstinent from alcohol use in prior 30 days

    prior 30 days (at 3-month follow-up)

  • Number Initiating Alcohol Use Disorder Treatment

    Number Attending any Alcohol Use Disorder Treatment Session(s) over 3-month follow-up

    over 3 months

Study Arms (2)

CBT Phone Intervention

EXPERIMENTAL

Cognitive-Behavioral Therapy for Treatment Seeking, CBT-TS, a manualized behavioral intervention, administered by telephone in a single session.

Behavioral: CBT by Phone to Promote Treatment

Being Read A Pamphlet on Alcohol Treatment

ACTIVE COMPARATOR

Guided review of a National Institute on Alcohol Abuse and Alcoholism (NIAAA) pamphlet on AUD treatment, administered by telephone in a single session.

Other: Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment

Interventions

CBT by Phone to Promote TreatmentBEHAVIORAL

Structured phone intervention to identify concerns about getting alcohol use disorder treatment and to work through those concerns using cognitive behavioral principles.

CBT Phone Intervention
Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder TreatmentOTHER

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.

Being Read A Pamphlet on Alcohol Treatment

Eligibility Criteria

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Kenneth R. Conner
Organization
University of Rochester
kenneth_conner@urmc.rochester.edu
585-275-1211

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The University of Rochester based study team, led by MPI Conner, were masked to treatment assignment (which was performed at the Medical University of South Carolina), and the University of Rochester based team performed all follow-up assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Emergency Medicine

Study Record Dates

First Submitted

November 27, 2018

First Posted

November 29, 2018

Study Start

March 1, 2019

Primary Completion

July 21, 2022

Study Completion

July 21, 2022

Last Updated

October 4, 2023

Results First Posted

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)