Last updated on May 2020

Aripiprazole for Bipolar Disorder and Alcohol Use Disorder

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Manic Disorders | Alcohol abuse | Bipolar Disorder | Alcohol Use Disorder | Bipolar Disorders (Pediatric) | Alcohol Dependence
  • Age: Between 18 - 65 Years
  • Gender: Male or Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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