To further test the effectiveness of oxytocin in heavy drinkers, half of the cohort in the
proposed study will meet criteria for heavy drinking (>35 standard drinks/week [men], >28
standard drinks/week [women] for at least 4 consecutive weeks). However, the investigators
think it important to expand the cohort of the proposed study to include subjects with
moderate Alcohol Use Disorder (AUD) who meet lower drinking criteria so the outcome of the
study will be relevant to a larger percentage of individuals who have AUD. The lower drinking
criteria will be minimum of 14 drinks/week (women) or 21 drinks/week (men) with an average of
at least two heavy drinking days (≥5 standard drinks for men and ≥4 standard drinks for
women) each week in the 4-week period prior to screening. As in the R21-funded Preliminary
Study, individuals recruited from the community who meet study criteria based on assessment
during a screening clinic visit will be randomized to twice a day (BID) intranasal oxytocin
or intranasal placebo during a subsequent clinic visit. After instruction by research staff
during the randomization clinic visit, subjects will self-administer intranasal treatments
from blind-labeled spray bottles that they take home. During clinic visits at 1, 2, 3, 4, 6,
8, 10, and 12 weeks after randomization, drinking since the last visit will be quantified and
other measures summarized above will be obtained. Subjects will self-administer test
intranasal treatments for 12 weeks. Drinking will also be quantified during clinic visits at
6 and 12 weeks after cessation of intranasal treatments.
This clinical trial will be the first adequately powered, double blind, placebo-controlled
trial examining the efficacy and tolerability of BID intranasal oxytocin (40 IU/dose; 80
IU/d) on alcohol drinking in AUD. The trial will also be the first to prospectively examine
the effects of intranasal oxytocin on anxiety symptoms in individuals with AUD.
Phase:
Phase 2
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)