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Atypical Antipsychotic

Aripiprazole for Alcoholism

Phase 3
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial is a 12-week, randomized, double-blind, parallel-group, placebo-controlled study of aripiprazole in 132 persons with Alcohol Use Disorder (AUD) and bipolar I or II disorder, currently depressed or mixed phase. The primary aim is to assess change in alcohol use by the Timeline Followback (TLFB) method.

Eligible Conditions
  • Alcoholism
  • Bipolar Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Timeline Follow Back (TLFB)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AripiprazoleExperimental Treatment1 Intervention
Aripiprazole will be given to the participant beginning at 2 mg per day(QD) then titrating up to 5 mg QD at week 1, 10 mg QD at week 2, 15 mg QD at week 3 until the end of the preliminary phase. If the participant qualifies for the extension phase, then they will be titrated up again at week 12 to 30 mg QD.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo will be given to the participant beginning at 2mg QD then titrating up to 5 mg QD at week 1, 10 mg QD at week 2, 15 mg QD at week 3 until the end of the preliminary phase. If the participant qualifies for the extension phase, then they will be titrated up again at week 12 to 30 mg QD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aripiprazole
2012
Completed Phase 4
~5520

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,643 Total Patients Enrolled
7 Trials studying Alcoholism
462 Patients Enrolled for Alcoholism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does the FDA's stamp of approval mean for Aripiprazole?

"Aripiprazole has received a score of 3 from our Power team. Aripiprazole is in Phase 3 of clinical trials, meaning that while there is data supporting its efficacy, there are multiple rounds of data that support its safety."

Answered by AI

Are recruitment activities for this clinical trial still ongoing?

"The clinicaltrials.gov website contains current information that this study is looking for volunteers. The trial was originally posted on November 1st, 2016, and the most recent update was on January 31st, 2022. The study needs 132 patients from 1 site."

Answered by AI

Does the age limit for this trial stop at 80 years old?

"This trial is only for patients aged 18 to 65. However, if you do not meet this age criteria, there are 297 other trials that might be a better fit. For patients above the age of 65, there are 887 other trials."

Answered by AI

Is this the first time Aripiprazole is being studied?

"There are 11 ongoing studies evaluating aripiprazole's efficacy. 5 of those studies are in their third and final stage of clinical trials. Many of the studies are based in Yiwu, Zhejiang, but aripiprazole is being studied in 19 different locations."

Answered by AI

To be eligible for this clinical trial, what are the inclusion criteria?

"The requirements to join this trial are that the patient must suffer from manic disorder and be between 18-65 years old. So far, around 132 people have been enrolled in the study."

Answered by AI

How many test subjects are helping researchers by participating in this clinical trial?

"That is correct, the information available on clinicaltrials.gov states that the study is looking for more candidates. The listing for the trial was first posted on November 1st, 2016 and was updated on January 31st, 2022. The study is currently enrolling 132 participants at 1 site."

Answered by AI

For what purpose is Aripiprazole most commonly prescribed?

"Aripiprazole is a medication that is used to treat bipolar disorder. However, it can also be used to alleviate symptoms in other disorders such as tourette's disorder, major depressive disorder, and acute coryza."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
UT Southwestern
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. UT Southwestern: < 48 hours
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Aripiprazole for Bipolar Disorder and Alcohol Use Disorder
Sherwood Brown, MD, PhD 2016. "Aripiprazole for Bipolar Disorder and Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02918370.
~16 spots leftby Apr 2025
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