Phase
Condition
Alcohol Use Disorder
Addictions
Alcohol Dependence
Treatment
Placebo
Aripiprazole
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Outpatient men and women age 18-65 years old with bipolar I, II, Not OtherwiseSpecified (NOS) disorder, or Schizoaffective Bipolar Type
If diagnosed with Bipolar I, Bipolar NOS w/history of mania or SchizoaffectiveDisorder 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 oforthostatic 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 tointake for men, and an average of 8 drinks per 7 day period in the past 28 daysprior to intake for women
Current mood stabilizer therapy with stable dose for > 28 days
Fluent in English or Spanish
Exclusion
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 bipolartype (e.g. cyclothymic disorders, schizophrenia, schizoaffective disorder depressivetype, or unipolar depression based on the SCID), other disorders, e.g. anxietydisorders, will be allowed.
Current diagnosis of amphetamine or cocaine use disorder or a cocaine or amphetaminepositive 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 thelast 28 days
Prior treatment with Aripiprazole within the last year or lifetime history ofintolerable side effects to Aripiprazole
Vulnerable populations (e.g. pregnant, nursing, cognitively impaired, incarcerated.)
Evidence of clinically significant alcohol withdrawal symptoms defined as a CIWA-Arscore of ≥ 10.
High risk for suicide
Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) > 3 times upperlimit 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 disorderis no greater than moderate severity and alcohol is the self-identified substance ofchoice.
History of neuroleptic malignant syndrome or tardive dyskinesia.
More specific inclusion and exclusion criteria will be discussed with participant at baseline assessment.
Study Design
Connect with a study center
UT Southwestern
Dallas, Texas 75235
United StatesSite Not Available
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