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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03339024
First Posted: November 9, 2017
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
St. Olavs Hospital
Lade Addiction Treatment Center
Information provided by (Responsible Party):
Norwegian University of Science and Technology
November 7, 2017
November 9, 2017
November 9, 2017
November 2017
December 2018   (Final data collection date for primary outcome measure)
  • Alcohol intake [ Time Frame: 60 days ]
    using self-reported alcohol use (days used and alcohol units)
  • Alcohol intake [ Time Frame: 1 year ]
    using the Timeline Follow-back method and phosphatidylethanol (PEth) blood test
Same as current
No Changes Posted
  • Sleep [ Time Frame: 60 days ]
    self-reported sleeping hours
  • Sleep [ Time Frame: 1 year ]
    self-reported sleeping hours
  • Number of rehospitalisations and readmissions to treatment for substance use disorders [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
 
Intranasal Oxytocin Effects in Alcohol Withdrawal and Dependence; Follow-up Study
Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: Follow-up of a Randomized Controlled Trial
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Alcoholism
  • Substance-Related Disorders
  • Drug: 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.
    Other Name: Syntocinon
  • Other: 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 Name: placebo
  • Experimental: 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

    Intervention: Drug: intranasal oxytocin spray
  • Placebo Comparator: 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

    Intervention: Other: intranasal spray without oxytocin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
40
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • participants in the RCT (NCT02903251) who completed the study

Exclusion Criteria:

  • participants in the RCT (NCT02903251) who did not complete the study
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT03339024
2016/45
2015-004463-37 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Norwegian University of Science and Technology
Norwegian University of Science and Technology
  • St. Olavs Hospital
  • Lade Addiction Treatment Center
Principal Investigator: Olav Spigset, MD PhD Norwegian University of Science and Technology
Norwegian University of Science and Technology
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP