Ondansetron for Bipolar Disorder and Alcohol Use Disorders

Study ID
STU 112013-075

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other

Contact
Kendra Malone
469/569-0168
kendra.malone@utsouthwestern.edu

Principal Investigator
Edson Brown

Summary

a 12-week, randomized, double-blind, parallel-group, placebo-controlled study of ondansetron in 70 persons with early-onset alcohol use disorder and BPD (currently depressed), is proposed. Changes in alcohol use and mood will be assessed. Flexible dosing, based on depressive symptoms and alcohol use, will be utilized beginning at the low doses used for alcohol dependence and upwardly titrating, if needed, to the higher doses used for schizophrenia.

Participants will be randomized on a 1:1 ratio to either placebo or ondansetron and followed for 12 weeks. each arm will start their dose at 0.5 mg BiD, with possible dose increases throughout the study to a potential maximum dose of 4.0 mg BiD. Dose increases will be dependent on the participant's data throughout the study.

Primary outcome measures will be depressive symptoms as measured on the HRSD (depression scale) and self-reported drinking activity as recorded by the Timeline Follow Back, specifically looking at drinks per week.

Participant Eligibility


* Outpatient men and women age 18-65 years old with bipolar I, II or NOS disorder.

* Current depressed mood state.

* Current diagnosis of alcohol use disorder (DSM V terminology) with onset <= age 25.

* Alcohol use (by self-report) of at least 15 drinks in the 7 days prior to intake.

* Current mood stabilizer therapy (lithium, anticonvulsant, atypical antipsychotic) with stable dose for at least 14 days prior to randomization.