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

Phase 3

Completed

• Conditions: Substance-Related Disorders; Alcoholism
• Interventions: Drug: intranasal oxytocin spray; Other: intranasal spray without oxytocin

• Registration Number: NCT03339024
• Lead Sponsor: Norwegian University of Science and Technology

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-09
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-16
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oxytocin	intranasal oxytocin spray	intranasal oxytocin spray Day 1-3: Twice daily intranasal oxytocin spray administered by health personnel. Day 3-30:Self-administered intranasal spray as needed, max thrice daily
Placebo	intranasal spray without oxytocin	intranasal spray without oxytocin Day 1-3: Twice daily intranasal spray without oxytocin, administered by health personnel. Day 3-30: Self-administered intranasal spray as needed, max thrice daily

Primary Outcome Measures

Name	Time	Method
Alcohol intake	1 year	using the Timeline Follow-back method and phosphatidylethanol (PEth) blood test

Secondary Outcome Measures

Name	Time	Method
Number of rehospitalisations and readmissions to treatment for substance use disorders	1 year
Sleep	1 year	self-reported sleeping hours

Trial Locations

Locations (1)

Lade Addiction Treatment Center; 🇳🇴 Trondheim, Norway