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

Primary Purpose

Alcoholism, Substance-Related Disorders

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
intranasal oxytocin spray
intranasal spray without oxytocin
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Oxytocin, Administration, Intranasal, Ethanol, Follow-up Studies

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • participants in the RCT (NCT02903251) who did not complete the study

Sites / Locations

  • Lade Addiction Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

oxytocin

Placebo

Arm Description

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 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

Outcomes

Primary Outcome Measures

Alcohol intake
using self-reported alcohol use (days used and alcohol units)
Alcohol intake
using the Timeline Follow-back method and phosphatidylethanol (PEth) blood test

Secondary Outcome Measures

Sleep
self-reported sleeping hours
Sleep
self-reported sleeping hours
Number of rehospitalisations and readmissions to treatment for substance use disorders

Full Information

First Posted
November 7, 2017
Last Updated
February 16, 2020
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Lade Addiction Treatment Center
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1. Study Identification

Unique Protocol Identification Number
NCT03339024
Brief Title
Intranasal Oxytocin Effects in Alcohol Withdrawal and Dependence; Follow-up Study
Official Title
Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: Follow-up of a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Lade Addiction Treatment Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Substance-Related Disorders
Keywords
Oxytocin, Administration, Intranasal, Ethanol, Follow-up Studies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oxytocin
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
intranasal oxytocin spray
Other Intervention Name(s)
Syntocinon
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
intranasal spray without oxytocin
Other Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Alcohol intake
Description
using self-reported alcohol use (days used and alcohol units)
Time Frame
60 days
Title
Alcohol intake
Description
using the Timeline Follow-back method and phosphatidylethanol (PEth) blood test
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Sleep
Description
self-reported sleeping hours
Time Frame
60 days
Title
Sleep
Description
self-reported sleeping hours
Time Frame
1 year
Title
Number of rehospitalisations and readmissions to treatment for substance use disorders
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: participants in the RCT (NCT02903251) who completed the study Exclusion Criteria: participants in the RCT (NCT02903251) who did not complete the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olav Spigset, MD PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lade Addiction Treatment Center
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32053696
Citation
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.
Results Reference
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Learn more about this trial

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

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