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Aripiprazole for Bipolar Disorder and Alcohol Use Disorder

Primary Purpose

Bipolar Disorder, Alcoholism, Alcohol Abuse

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Aripiprazole

Placebo

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Alcohol Use Disorder, Bipolar Disorder, Mood, Alcohol Craving, Aripiprazole, Schizoaffective Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UT Southwestern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aripiprazole

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Timeline Follow Back (TLFB)

The Timeline Followback is used to assess recent alcohol use (and if present, other substance use).

Secondary Outcome Measures

Full Information

NCT ID

NCT02918370

First Posted

September 27, 2016

Last Updated

August 1, 2023

Sponsor

University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02918370

Brief Title

Aripiprazole for Bipolar Disorder and Alcohol Use Disorder

Official Title

Aripiprazole for Bipolar Disorder and Alcohol Use Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

November 2016 (Actual)

Primary Completion Date

June 30, 2023 (Actual)

Study Completion Date

June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The investigators will conduct 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. Primary Aim will be to assess change in alcohol use by the Timeline Followback (TLFB) method. Secondary Aim will include change in alcohol craving using the Penn Alcohol Craving Scale (PACS). Changes in psychiatric symptoms (mania/hypomania and depression) and predictors of response will be assessed. Participants with ≥ 1 drinking day at week 12 will be enrolled in a 4-week extension phase with an upward titration to 30 mg/day for those in the active treatment group. The placebo group will remain on placebo. Subjects will be discontinued from the study if any of the following conditions occurs: change in diagnosis to other than bipolar I or II disorder and AUD, development of active suicidal or homicidal ideation with plan and intent, worsening in mood symptoms, that in the opinion of the investigators requires discontinuation, pregnancy, development of severe or life-threatening medical condition, involuntary psychiatric hospitalization or incarceration, significant alcohol withdrawal (e.g. delirium tremens) based on clinical judgment (increases in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores will initiate a careful clinical assessment of possible worsening of withdrawal symptoms), or cocaine or amphetamine-positive urine drug screen during the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder, Alcoholism, Alcohol Abuse

Keywords

Alcohol Use Disorder, Bipolar Disorder, Mood, Alcohol Craving, Aripiprazole, Schizoaffective Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aripiprazole

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Aripiprazole

Other Intervention Name(s)

Abilify

Intervention Description

Aripiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders. It works to restore the balance of neurotransmitters.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sugar Pill

Intervention Description

Inactive ingredient matching the active comparators in appearance.

Primary Outcome Measure Information:

Title

Timeline Follow Back (TLFB)

Description

The Timeline Followback is used to assess recent alcohol use (and if present, other substance use).

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

UT Southwestern

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Aripiprazole for Bipolar Disorder and Alcohol Use Disorder

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