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

N

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

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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