Aripiprazole for Bipolar Disorder and Alcohol Use Disorder

Last updated: September 11, 2024
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Completed

Phase

3

Condition

Alcohol Use Disorder

Addictions

Alcohol Dependence

Treatment

Placebo

Aripiprazole

Clinical Study ID

NCT02918370
102015-062
  • Ages 18-65
  • All Genders

Study 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.

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

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 01, 2016
Estimated Completion Date:
June 30, 2023

Connect with a study center

  • UT Southwestern

    Dallas, Texas 75235
    United States

    Site Not Available

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