Treatment of Young Adults With Comorbid AUD/MDD: A Pilot Medication Trial
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
Recent reports have shown that alcohol misuse is a particularly serious problem among the 18
to 25 year old age group. Previous medication trials with SSRI antidepressants among young
adults with co-occurring depressive disorders, including our own recent trials with SSRI
medications, have produced disappointing results, especially for decreasing the level of
alcohol consumption. Mirtazapine is a non-SSRI medication with a unique structure and
mechanism of action. Recent study results suggest that mirtazapine is more effective than
other antidepressants for treating non-comorbid depression. A few recent studies with
mirtazapine have been conducted among subjects with comorbid AUD/MDD, and those studies have
demonstrated efficacy for mirtazapine for decreasing the depressive symptoms and the alcohol
craving of subjects with comorbid AUD/MDD. However, those studies did not measure level of
alcohol consumption, so it is unclear whether mirtazapine decreases the level of alcohol use
of that comorbid population. The results of our own very recent open label pilot study
suggest robust within-group efficacy for mirtazapine for decreasing both the level of alcohol
use and the depressive symptoms of comorbid subjects. However, that pilot study did not
include a placebo control group, so the efficacy of mirtazapine versus placebo for decreasing
the level of alcohol use among persons with comorbid AUD/MDD remains unclear. This grant
submission proposes to conduct a first double-blind, placebo-controlled pilot study to
provide a preliminary assessment of the efficacy of mirtazapine versus placebo for decreasing
both the alcohol use and depressive symptoms of young adults with comorbid AUD/MDD. If
results (effect sizes) from the proposed study are found to be promising concerning outcome
differences between the mirtazapine and placebo groups, then we will use those findings to
apply for an R01 study to definitively assess the efficacy of mirtazapine for treating young
adults with AUD/MDD.