NCT03339024

Intranasal Oxytocin Effects in Alcohol Withdrawal and Dependence; Follow-up Study

Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: Follow-up of a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is an assessment of the long-term effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol after 60 days and 1 year. It is a follow-up study of a placebo-controlled randomized controlled study where subjects used oxytocin nasal spray during acute withdrawal and the following 4 weeks in an outpatient setting. Half of the participants have received oxytocin nasal spray, the other half placebo nasal spray (NCT02903251). (added March 2019: 24 patients were available for 1-year follow-up)

Conditions

• Alcoholism
• Substance-Related Disorders

Interventions

Type	Name	Description
DRUG	intranasal oxytocin spray	6 insufflations (24 IU of oxytocin total) given twice daily, day 1-3. 2 insufflations (8 IU of oxytocin total) as needed, max thrice daily, day 3-30 Day 30 - 12 months: No further oxytocin treatment, i.e. treatment-as-usual.
OTHER	intranasal spray without oxytocin	6 insufflations (24 IU of placebo total) given twice daily, day 1-3. 2 insufflations (8 IU of placebo total) as needed, max thrice daily, day 3-30 Day 30 - 12 months: No further oxytocin treatment, i.e. treatment-as-usual.

Timeline

• Start date: 2017-11-01
• Primary completion: 2019-03-31
• Completion: 2019-03-31
• First posted: 2017-11-09
• Last updated: 2020-02-19

Locations

1 site across 1 country: Norway