Aripiprazole for Bipolar Disorder and Alcohol Use Disorder
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.