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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03339024

Enrollment

Registered

2017-11-09

Start date

2017-11-01

Completion date

2019-03-31

Last updated

2020-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism, Substance-Related Disorders

Keywords

Oxytocin, Administration, Intranasal, Ethanol, Follow-up Studies

Brief 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)

Interventions

DRUGintranasal 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.

OTHERintranasal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Alcohol intake	60 days	using self-reported alcohol use (days used and alcohol units)

Secondary

Measure	Time frame	Description
Sleep	60 days	self-reported sleeping hours
Number of rehospitalisations and readmissions to treatment for substance use disorders	1 year	—

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026