Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Talk Therapy by Phone to Promote Treatment for Alcohol Problems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03758274
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : October 29, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Medical University of South Carolina
Syracuse University
Information provided by (Responsible Party):
Kenneth Conner, University of Rochester

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Alcohol Abuse Behavioral: CBT by Phone to Promote Treatment Other: Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Treatment by Phone to Promote Use of Alcohol Related Care and Reduce Drinking
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
Drug Information available for: Ethanol

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: CBT Phone 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.
Active Comparator: Being Read A Pamphlet on Alcohol Treatment 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Average drinks per drinking day [ Time Frame: 30 days ]
    Average number of standard drinks on days of alcohol consumption

  2. Percent days abstinent [ Time Frame: 30 days ]
    Percentage of days abstinent from alcohol

  3. Number Initiating Alcohol Use Disorder Treatment [ Time Frame: 30 days ]
    Attendance at Alcohol Use Disorder Treatment


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758274


Contacts
Layout table for location contacts
Contact: Alcohol Study 585-455-5785 Alcoholstudy@urmc.rochester.edu

Locations
Layout table for location information
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Alcohol Study    585-455-5785    AlcoholStudy@urmc.rochester.edu   
Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)
Medical University of South Carolina
Syracuse University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Kenneth Conner, Professor, Emergency Medicine, University of Rochester
ClinicalTrials.gov Identifier: NCT03758274    
Other Study ID Numbers: RSRB00072850
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders