Oxytocin Treatment for Alcohol Use Disorders

Summary

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.

Conditions

• Alcohol Use Disorder

Interventions

DRUG

Oxytocin

Oxytocin will be given in an intranasal spray (Syntocinon Spray) twice daily (10 insufflations, 1.0 mL, 40 IU/dose) for 12 weeks

DRUG

Placebo

Placebo solution (contained all the ingredients in Syntocinon Spray except for oxytocin) will be given as an intranasal spray twice daily (10 insufflations, 1.0 mL/dose) for 12 weeks

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Cort Pedersen, MD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-31

Primary Completion

2022-09-30

Completion

2022-09-30

FDA Drug

Yes

Countries

• United States

Study Locations