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.

Summary

We will conduct a 12-week, randomized, double-blind, parallel-group, placebo-controlled study of aripiprazole in 132 persons with auD and Bipolar i, ii or noS disorder. Primary aim will be to assess change in alcohol use by the Timeline Followback (TLFB) method.29, 30 Secondary aim will include change in alcohol craving using the Penn alcohol Craving Scale (PaCS).31 Changes in psychiatric symptoms (mania/hypomania and depression) and predictors of response will be assessed. Participants with [GreaterThanorequalTo] 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, ii, or noS 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, or significant alcohol withdrawal (e.g. delirium tremens) based on clinical judgment (increases in CiWa-ar scores will initiate a careful clinical assessment of possible worsening of withdrawal symptoms).

Participant Eligibility

- Outpatient men and women age 18-65 years old with bipolar I, II, or NOS disorder on the SCID and confirmed by interview with a psychiatrist.
- Current diagnosis of AUD with at least moderate severity (DSM-5 terminology).
- Alcohol use (by TLFB) 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 (lithium, valproic acid) with stable dose for >= 28 days prior to randomization.
- Baseline BIS-11 score of > 62 (above average impulsivity).
- Fluent in English or Spanish.
- SBP > 100 and < 165 and DBP > 60 and < 105 with no evidence of orthostatic hypotension