Alcohol Use DisorderNCT03758274

Talk Therapy by Phone to Promote Treatment for Alcohol Problems

A study testing CBT by Phone to Promote Treatment and Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment in people with Alcohol Use Disorder and Alcohol Abuse, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Alcohol Use Disorder, Alcohol Abuse
What is being tested?: CBT by Phone to Promote Treatment and Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2019to 21 Jul 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester
Rochester, New York, 14642

Other trials in United States

About this study

Official title: Cognitive Behavioral Treatment by Phone to Promote Use of Alcohol Related Care and Reduce Drinking

Conditions: Alcohol Use Disorder, Alcohol Abuse
Being tested: CBT by Phone to Promote Treatment, Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment
Medical subject headings: Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03758274
Study group	Role	What they receive
CBT Phone Intervention	Experimental	Cognitive-Behavioral Therapy for Treatment Seeking, CBT-TS, a manualized behavioral intervention, administered by telephone in a single session. Receives: 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. Receives: Other: Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Drinks Per Drinking Day
Average number of standard drinks on days of alcohol consumption at 3-month follow-up
Measured: prior 30 days (at 3-month follow-up)
Days Abstinent
Number of days abstinent from alcohol use in prior 30 days
Measured: 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
Measured: over 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201921 Jul 2022

First posted29 Nov 2018
Study start1 Mar 2019
Primary completion21 Jul 2022
Study completion21 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
More trials run by University of RochesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03758274
Sponsor's protocol ID: RSRB00072850
Other IDs: R01AA026815-01
Status last verified: Oct 2023
First submitted: 27 Nov 2018
Last updated: 4 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcohol Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cognitive Behavioral Treatment by Phone to Promote Use of Alcohol Related Care and Reduce Drinking
ClinicalTrials.gov ID: NCT03758274
Acronym / sponsor ID: RSRB00072850
Conditions: Alcohol Use Disorder, Alcohol Abuse
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA), Medical University of South Carolina, Syracuse University
Study start: 1 Mar 2019 (actual)
Primary completion: 21 Jul 2022 (actual)
Study completion: 21 Jul 2022 (actual)
First posted: 29 Nov 2018 (actual)
Results: Posted 4 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CBT Phone Intervention	Experimental	Behavioral: CBT by Phone to Promote TreatmentCognitive-Behavioral Therapy for Treatment Seeking, CBT-TS, a manualized behavioral intervention, administered by telephone in a single session.
Being Read A Pamphlet on Alcohol Treatment	Active comparator	Other: Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder TreatmentGuided review of a National Institute on Alcohol Abuse and Alcoholism (NIAAA) pamphlet on AUD treatment, administered by telephone in a single session.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CBT by Phone to Promote TreatmentStructured phone intervention to identify concerns about getting alcohol use disorder treatment and to work through those concerns using cognitive behavioral principles.	Behavioural	CBT Phone Intervention
Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder TreatmentThe 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.	Other	Being Read A Pamphlet on Alcohol Treatment

Primary outcome

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

Results and safety

Results posted to the registry on 4 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CBT Phone Intervention	197	186
Being Read A Pamphlet on Alcohol Treatment	203	190

Primary outcome: Average Drinks Per Drinking Day

Time frame: prior 30 days (at 3-month follow-up). Mean (Standard Deviation). Unit: drinks per occasion

Measure	CBT Phone Intervention n = 197	Being Read A Pamphlet on Alcohol Treatment n = 203
Value	5.5 (3.8)	5.4 (3.5)

CBT Phone Intervention vs Being Read A Pamphlet on Alcohol Treatment: p = 0.746, Based on simple path model in Mplus.

Primary outcome: Days Abstinent

Time frame: prior 30 days (at 3-month follow-up). Mean (Standard Deviation). Unit: Days abstinent (in past 30 days)

Measure	CBT Phone Intervention n = 197	Being Read A Pamphlet on Alcohol Treatment n = 203
Value	15.5 (10.5)	14.6 (9.9)

CBT Phone Intervention vs Being Read A Pamphlet on Alcohol Treatment: p = 0.247, Based on simple path model in Mplus.

Primary outcome: Number Initiating Alcohol Use Disorder Treatment

Time frame: over 3 months. Count of participants. Unit: Participants

Measure	CBT Phone Intervention n = 197	Being Read A Pamphlet on Alcohol Treatment n = 203
Value	38	36

CBT Phone Intervention vs Being Read A Pamphlet on Alcohol Treatment: p = 0.689, Chi-squared

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CBT Phone Intervention	0 of 197 (0%)	0 of 197 (0%)	0 of 197
Being Read A Pamphlet on Alcohol Treatment	0 of 203 (0%)	1 of 203 (0.5%)	0 of 203

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Drinks Per Drinking Day (time frame: prior 30 days (at 3-month follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03758274.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.