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

Norwegian University of Science and Technology

Status and phase: Completed; Phase 3

Conditions: Alcoholism; Substance-Related Disorders

Treatments: Other: intranasal spray without oxytocin; Drug: intranasal oxytocin spray

Study type: Interventional

Funder types: Other

Identifiers

NCT03339024

2015-004463-37 (EudraCT Number)

2016/45

Details and patient eligibility

About

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)

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups, including a placebo group

oxytocin

Experimental group

Description:

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

Treatment:

Drug: intranasal oxytocin spray

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: intranasal spray without oxytocin