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

Study Overview
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Brief Summary
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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)

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

Conditions
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Alcoholism, Substance-Related Disorders

Intervention / Treatment
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* Drug: intranasal oxytocin spray
* Other: intranasal spray without oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants in the RCT (NCT02903251) who completed the study Exclusion Criteria: participants in the RCT (NCT02903251) who did not complete the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxytocin<br>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 | Drug: intranasal oxytocin spray<br>* 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.<br>* Other names: Syntocinon;|
| Placebo Comparator: Placebo<br>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 | Other: intranasal spray without oxytocin<br>* 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.<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol intake | using self-reported alcohol use (days used and alcohol units) | 60 days | 
| Alcohol intake | using the Timeline Follow-back method and phosphatidylethanol (PEth) blood test | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxytocin, Administration, Intranasal, Ethanol, Follow-up Studies