Aripiprazole for Bipolar Disorder and Alcohol Use Disorder

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    132
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 19 June 2021
depression
valproic acid
gabapentin
lamotrigine
bipolar disorder
mood symptoms
depressed mood
mania
suicidal
aripiprazole
lithium
mood stabilizer
alcohol use disorder
psychiatric symptoms
alcohol withdrawal syndrome
withdrawal symptom
delirium tremens
schizoaffective disorder
atypical antipsychotic
psychiatric hospitalization

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.

Details
Condition Bipolar Disorder, Alcohol abuse, Alcohol Use Disorder, Bipolar Disorders (Pediatric), Alcohol Dependence, Manic Disorders, alcoholism, alcohol dependence syndrome, chronic alcoholism
Treatment Placebo, Aripiprazole
Clinical Study IdentifierNCT02918370
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on19 June 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note