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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
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.
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.
Lade Addiction Treatment Center
Trondheim, Norway
Alcohol intake
using self-reported alcohol use (days used and alcohol units)
Time frame: 60 days
Alcohol intake
using the Timeline Follow-back method and phosphatidylethanol (PEth) blood test
Time frame: 1 year
Sleep
self-reported sleeping hours
Time frame: 60 days
Sleep
self-reported sleeping hours
Time frame: 1 year
Number of rehospitalisations and readmissions to treatment for substance use disorders
Time frame: 1 year
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