Aripiprazole for Bipolar Disorder and Alcohol Use Disorder

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified August 2024 by University of Texas Southwestern Medical Center
Sponsor
University of Texas Southwestern Medical Center
Information Provided by (Responsible Party)
Sherwood Brown, MD, PhD
Clinicaltrials.gov Identifier
NCT02918370
Other Study ID Numbers:
102015-062
First Submitted
September 26, 2016
First Posted
September 27, 2016
Results First Posted
June 27, 2024
Last Update Posted
September 18, 2024
Last Verified
August 2024

ClinicalTrials.gov processed this data on September 2024. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Bipolar DisorderAlcoholismAlcohol Abuse
Drug: AripiprazoleDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment75 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleAripiprazole for Bipolar Disorder and Alcohol Use Disorder
Study Start DateOctober 31, 2016
Actual Primary Completion DateJune 29, 2023
Actual Study Completion DateJune 29, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
Aripiprazole
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.
Drug: Aripiprazole
Aripiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders. It works to restore the balance of neurotransmitters.
Placebo
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.
Drug: Placebo
Inactive ingredient matching the active comparators in appearance.

Outcome Measures

Primary Outcome Measures
  1. Timeline Follow Back (TLFB)
    The Timeline Followback (TLFB) is used to assess recent alcohol use (and if present, other substance use). The calculation is based on the change between baseline and week 12.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Outpatient men and women age 18-65 years old with bipolar I, II, Not Otherwise Specified (NOS) disorder, or Schizoaffective Bipolar Type
If diagnosed with Bipolar I, Bipolar NOS w/history of mania or Schizoaffective Disorder Bipolar Type, current mood stabilizer therapy (lithium, valproic acid, lamotrigine, gabapentin) with stable dose for \> 28 days prior to randomization.
Baseline Barrett Impulsiveness Scale-11 Score of \> 62 (above average impulsivity)
Systolic BP \> 100 and \< 165 and Diastolic BP \> 60 and \< 105 with no evidence of orthostatic hypotension
Current Diagnosis of Alcohol Use Disorder with at least moderate severity
Alcohol use of an average of 15 drinks per 7 days in the past 28 days prior to intake for men, and an average of 8 drinks per 7 day period in the past 28 days prior to intake for women
Current mood stabilizer therapy with stable dose for \> 28 days
Fluent in English or Spanish
Exclusion Criteria
Baseline Hamilton Rating Scale for Depression (HRSD) or Young Mania Rating Scale (YMRS) scores \> 35
Mood disorders other than bipolar I, II, NOS or schizoaffective disorder bipolar type (e.g. cyclothymic disorders, schizophrenia, schizoaffective disorder depressive type, or unipolar depression based on the SCID), other disorders, e.g. anxiety disorders, will be allowed.
Current diagnosis of amphetamine or cocaine use disorder or a cocaine or amphetamine positive baseline urine sample.
Evidence of clinically significant alcohol withdrawal symptoms
Current treatment with an atypical antipsychotic
Current treatment with naltrexone, acamprosate, disulfiram, or topiramate in the last 28 days
Prior treatment with Aripiprazole within the last year or lifetime history of intolerable side effects to Aripiprazole
Vulnerable populations (e.g. pregnant, nursing, cognitively impaired, incarcerated.)
Evidence of clinically significant alcohol withdrawal symptoms defined as a CIWA-Ar score of ≥ 10.
High risk for suicide
Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) \> 3 times upper limit of normal
Current use of Cytochrome P450 3A4 inducing medication (e.g. carbamazepine, rifabutin, rifampin, ritonavir).
Use of other substances (besides cocaine/amphetamine) is allowed if the use disorder is no greater than moderate severity and alcohol is the self-identified substance of choice.
History of neuroleptic malignant syndrome or tardive dyskinesia. More specific inclusion and exclusion criteria will be discussed with participant at baseline assessment.

Contacts and Locations

Sponsors and CollaboratorsUniversity of Texas Southwestern Medical Center
Locations
UT Southwestern | Dallas Texas, United States, 75235
Study Documents (Full Text)
Documents provided by University of Texas Southwestern Medical Center: Study Protocol and Statistical Analysis Plan  May 18, 2023