NCT03758274

Talk Therapy by Phone to Promote Treatment for Alcohol Problems

Completed NA Results posted Last updated 4 October 2023

What this trial tests

NA trial testing CBT by Phone to Promote Treatment in Alcohol Use Disorder in 400 participants. Completed in 21 July 2022.

Timeline

1 March 2019

Primary endpoint
21 July 2022

21 July 2022

Quick facts

Lead sponsor	University of Rochester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	400
Start date	1 March 2019
Primary completion	21 July 2022
Estimated completion	21 July 2022
Sites	1 location across United States

Drugs / interventions tested

• CBT by Phone to Promote Treatment
• Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →
• Alcohol Abuse — all drugs for Alcohol Abuse →

Sponsor

University of Rochester

Who can join

18 and older, any sex, with Alcohol Use Disorder or Alcohol Abuse. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Drinks Per Drinking Day Primary · prior 30 days (at 3-month follow-up)

Average number of standard drinks on days of alcohol consumption at 3-month follow-up

Group	Value	95% CI
CBT Phone Intervention	5.5	± 3.8
Being Read A Pamphlet on Alcohol Treatment	5.4	± 3.5

Days Abstinent Primary · prior 30 days (at 3-month follow-up)

Number of days abstinent from alcohol use in prior 30 days

Group	Value	95% CI
CBT Phone Intervention	15.5	± 10.5
Being Read A Pamphlet on Alcohol Treatment	14.6	± 9.9

Number Initiating Alcohol Use Disorder Treatment Primary · over 3 months

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

Group	Value	95% CI
CBT Phone Intervention	38
Being Read A Pamphlet on Alcohol Treatment	36

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CBT Phone Intervention

Serious: 0/197 (0%)

Deaths: 0/197

Being Read A Pamphlet on Alcohol Treatment

Serious: 0/203 (0%)

Deaths: 0/203

Other adverse events (1 terms — click to expand)

Reaction	System	CBT Phone Intervention	Being Read A Pamphlet on A…
Acute alcohol withdrawal	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT03758274 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Brief, cognitive-behavioral intervention to promote treatment seeking in adults with severe alcohol use disorder: A randomized controlled trial.
   Conner KR, Maisto SA, Abar B, Szafranski S, et al · · 2023 · cited 8× · PMID 37488997 · DOI 10.1111/add.16300
2. An assessment of beliefs about mental health care among community-based adults with severe, untreated alcohol use disorder.
   Hutchison M, Szafranski S, Titus C, Abar B, et al · · 2024 · PMID 38832908 · DOI 10.1093/alcalc/agae037