Aripiprazole for Bipolar Disorder and Alcohol Use Disorder

Study ID
STU 102015-062

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other

Contact
Anna Antony
903/806-5859
Anna.Antony@UTSouthwestern.edu

Principal Investigator
Edson Brown, M.D., Ph.D.

Official Title

Aripiprazole for Bipolar Disorder and Alcohol Use Disorder

Brief Overview

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.

Eligibility

Inclusion Criteria:
- Outpatient men and women age 18-65 years old with bipolar I, II, or Not Otherwise Specified (NOS) disorder
- Current Diagnosis of Alcohol Use Disorder
- Current Alcohol use
- 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
- 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.)
- High risk for suicide
- Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) > 3 times upper limit of normal
- Current use of a Cytochrome P450 3A4 enzyme inducing medication ( e.g. carbamazepine, rifabutin, rifampin, ritonavir.)
More specific inclusion and exclusion criteria will be discussed with participant at baseline assessment.