Aripiprazole for Bipolar Disorder and Alcohol Use Disorder
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|ClinicalTrials.gov Identifier: NCT02918370|
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : February 15, 2023
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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.
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Alcoholism Alcohol Abuse||Drug: Aripiprazole Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Aripiprazole for Bipolar Disorder and Alcohol Use Disorder|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Aripiprazole will be given to the participant beginning at 2 mg per day(QD) then titrating up to 5 mg QD at week 1, 10 mg QD at week 2, 15 mg QD at week 3 until the end of the preliminary phase. If the participant qualifies for the extension phase, then they will be titrated up again at week 12 to 30 mg QD.
Aripiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders. It works to restore the balance of neurotransmitters.
Other Name: Abilify
Placebo Comparator: Placebo
Matching placebo will be given to the participant beginning at 2mg QD then titrating up to 5 mg QD at week 1, 10 mg QD at week 2, 15 mg QD at week 3 until the end of the preliminary phase. If the participant qualifies for the extension phase, then they will be titrated up again at week 12 to 30 mg QD.
Inactive ingredient matching the active comparators in appearance.
Other Name: Sugar Pill
- Timeline Follow Back (TLFB) [ Time Frame: 12 weeks ]The Timeline Followback is used to assess recent alcohol use (and if present, other substance use).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918370
|Contact: Shailesh Jaiswalfirstname.lastname@example.org|
|Contact: Maisha Razzaqueemail@example.com|
|United States, Texas|
|Dallas, Texas, United States, 75235|
|Contact: Shailesh Jaiswal 2146456963 firstname.lastname@example.org|
|Contact: Traci Holmes 2146456959 email@example.com|
|Principal Investigator: E. Sherwood Brown, MD, PhD|
|Responsible Party:||Sherwood Brown, MD, PhD, Professor of Medicine, University of Texas Southwestern Medical Center|
|Other Study ID Numbers:||
|First Posted:||September 28, 2016 Key Record Dates|
|Last Update Posted:||February 15, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Alcohol Use Disorder
Bipolar and Related Disorders
Central Nervous System Depressants
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
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