Lade Addiction Treatment Center
Trondheim, Norway
NCT Number: NCT02903251
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 3
Trondheim, Norway
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Syntocinon
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.
Other names: placebo
Time frame: 3 days
total oxazepam dosage per subject during detoxification, as determined by Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-Ar) scores
Time frame: 30 days
Alcohol intake of outpatients, using blood, urine, Timeline Followback and diaries.
Time frame: 3 days
self-reported sleeping hours
Time frame: 30 days
self-reported sleeping hours
Time frame: 3 days
assessed by actigraph
Time frame: day 3
self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)
Time frame: day 30
self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)
Time frame: day 3
measured by Hopkins Symptoms Checklist 10 items (SCL-10)
Time frame: day 30
measured by Hopkins Symptoms Checklist 10 items (SCL-10)
Time frame: day 3
measured by Patient Activity Measure 13 (PAM-13)
Time frame: day 30
measured by Patient Activity Measure 13 (PAM-13)
Time frame: Day 2
assessed by Reading the mind in the eyes test (RMET)
Time frame: Day 3
assessed by Reading the mind in the eyes test (RMET)
Time frame: day 30
assessed by Reading the mind in the eyes test (RMET)
Time frame: Day 2
assessed by Visual Dot probe task
Time frame: Day 3
assessed by Visual Dot probe task
Time frame: day 30
assessed by Visual Dot probe task
Norwegian University of Science and Technology
Other
Acute and Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: A Prospective Randomized Parallel Group Placebo-controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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