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

Substance-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339024
• Other study ID #: 2016/45
• Secondary ID: 2015-004463-37
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: February 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• participants in the RCT (NCT02903251) who completed the study

Exclusion Criteria:

• participants in the RCT (NCT02903251) who did not complete the study

Related Conditions & MeSH terms

• Alcoholism
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
Norway	Lade Addiction Treatment Center	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Lade Addiction Treatment Center, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Melby K, Fasmer OB, Henriksen TE, Gråwe RW, Aamo TO, Spigset O. Actigraphy assessment of motor activity and sleep in patients with alcohol withdrawal syndrome and the effects of intranasal oxytocin. PLoS One. 2020 Feb 13;15(2):e0228700. doi: 10.1371/journ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol intake	using self-reported alcohol use (days used and alcohol units)	60 days
Primary	Alcohol intake	using the Timeline Follow-back method and phosphatidylethanol (PEth) blood test	1 year
Secondary	Sleep	self-reported sleeping hours	60 days
Secondary	Sleep	self-reported sleeping hours	1 year
Secondary	Number of rehospitalisations and readmissions to treatment for substance use disorders		1 year