This study evaluates the effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol, and during the following 4 weeks in an outpatient setting. Half of the participants will receive oxytocin nasal spray, the other half placebo nasal spray.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
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.
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.
Lade Addiction Treatment Center
Trondheim, Norway
Total oxazepam dosage in milligrams
total oxazepam dosage per subject during detoxification, as determined by Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-Ar) scores
Time frame: 3 days
Alcohol intake
Alcohol intake of outpatients, using blood, urine, Timeline Followback and diaries.
Time frame: 30 days
Sleep
self-reported sleeping hours
Time frame: 3 days
Sleep
self-reported sleeping hours
Time frame: 30 days
motor activity
assessed by actigraph
Time frame: 3 days
alcohol craving
self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)
Time frame: day 3
alcohol craving
self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)
Time frame: day 30
Mental distress
measured by Hopkins Symptoms Checklist 10 items (SCL-10)
Time frame: day 3
Mental distress
measured by Hopkins Symptoms Checklist 10 items (SCL-10)
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Time frame: day 30
patient activity
measured by Patient Activity Measure 13 (PAM-13)
Time frame: day 3
patient activity
measured by Patient Activity Measure 13 (PAM-13)
Time frame: day 30
Socio-emotional recognition
assessed by Reading the mind in the eyes test (RMET)
Time frame: Day 2
Socio-emotional recognition
assessed by Reading the mind in the eyes test (RMET)
Time frame: Day 3
Socio-emotional recognition
assessed by Reading the mind in the eyes test (RMET)
Time frame: day 30
Facial emotional selective attention
assessed by Visual Dot probe task
Time frame: Day 2
Facial emotional selective attention
assessed by Visual Dot probe task
Time frame: Day 3
Facial emotional selective attention
assessed by Visual Dot probe task
Time frame: day 30