Oxytocin Treatment for Alcohol Use Disorders

• Status: Withdrawn
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

1. Men and women between the ages of 21 and 65. Children, ages less than 21 years, and adults over 65 years will not be studied because of the lack of safety data on the use of oxytocin in these age ranges.

2. All subjects must meet DSM-V criteria for moderate or severe alcohol use disorder. In addition the investigators will recruit 50% of individuals (evenly distributed between men and women) who meet criteria for heavy drinking: > 28 standard drinks/week (women) or >35 drinks/week (men) in the 30-day period prior to screening. Those not meeting heavy drinking criteria will be required to have a 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) per week in the 30 day period prior to screening

3. Ability to understand and sign written informed consent.

4. Must have a 0.0 gms/dL breathalyzer reading on the day of screening and < 0.4 gms/dL on the day of randomization.

5. Express a desire to achieve abstinence or to greatly reduce alcohol consumption

6. Must have a stable residence and be able to identify an individual who could contact participant if needed.

Exclusion Criteria:

1. Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g., cirrhosis, unstable hypertension, unstable diabetes mellitus). Clinically significant psychiatric illness including any psychotic disorder, bipolar disorder, severe depression, or suicidal ideation.

2. Substance use disorder other than nicotine use disorder or mild cannabis use disorder. Occasional use of cocaine is acceptable.

3. Concurrent use of any psychotropic medication including, mood stabilizers, antipsychotics, anxiolytics, stimulants, or hypnotics with the exception of stable doses of antidepressants for one month.

4. Prior history of adverse reaction to oxytocin.

5. Serum sodium concentration < 134 mEq/L.

6. Creatinine level > 1.5 times Upper Limit of Normal (ULN) or Estimated Glomerular Filtration Rate < 50.

7. AST, or ALT > 5 times ULN or bilirubin > 1.5 X ULN.

8. Positive urine toxicology screen with the exception of cannabis. Individuals with positive cannabis screens will be excluded only if they have a history of moderate/severe cannabis use disorder.

9. Pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control (oral or depot contraceptive, or barrier methods such as diaphragm or condom with spermicidal).

10. Women who are breastfeeding.

11. Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol dependence.

12. Participation in any clinical trial within the past 60 days.

13. Court-mandated participation in alcohol treatment or pending incarceration.