Intranasal Oxytocin Effects in Alcohol Withdrawal and Dependence; Follow-up Study
NCT ID: NCT03339024
Last Updated: 2020-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
38 participants
INTERVENTIONAL
2017-11-01
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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oxytocin
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
intranasal oxytocin spray
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.
Placebo
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
intranasal spray without oxytocin
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.
Interventions
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intranasal oxytocin spray
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.
intranasal spray without oxytocin
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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St. Olavs Hospital
OTHER
Lade Addiction Treatment Center
UNKNOWN
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Olav Spigset, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Norwegian University of Science and Technology
Locations
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Lade Addiction Treatment Center
Trondheim, , Norway
Countries
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References
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Melby K, Fasmer OB, Henriksen TE, Grawe RW, Aamo TO, Spigset O. Actigraphy assessment of motor activity and sleep in patients with alcohol withdrawal syndrome and the effects of intranasal oxytocin. PLoS One. 2020 Feb 13;15(2):e0228700. doi: 10.1371/journal.pone.0228700. eCollection 2020.
Other Identifiers
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2015-004463-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2016/45
Identifier Type: -
Identifier Source: org_study_id
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