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Oxytocin and Alcohol Withdrawal and Dependence

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

Eligibility Criteria

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

Inclusion Criteria:

  1. At least one prior episode 2 days or longer in duration during which the subject experienced withdrawal symptoms that caused significant incapacitation (e.g., inability to work or do normal activities) OR at least one prior inpatient or outpatient medical detoxification during which the subject exhibited withdrawal symptoms of sufficient magnitude that sedative-hypnotic or anticonvulsant medication was required at least once on 2 consecutive days after cessation of or reduction in the use of alcohol following 2 weeks or more of heavy daily consumption
  2. average consumption of 8-30 standard drinks per day for at least 2 weeks prior to enrollment in the study;
  3. consenting to participate in the study;
  4. have residency in Trøndelag County after discharge

Exclusion Criteria:

  1. chronic treatment with sedative-hypnotic medications such as benzodiazepines or z-hypnotics;
  2. dependence on substances other than alcohol, nicotine or caffeine;
  3. inadequately treated, unstable and/or compromising medical or psychiatric conditions;
  4. low body weight (BMI < 17) or history of anorexia nervosa or bulimia in the past 2 years;
  5. pregnancy; parturition or breast-feeding in the past 6 months;
  6. inability to read well enough to complete study questionnaires determined by whether the prospective subject can read the consent form without help and correctly answer basic questions about information in the consent form;
  7. no alcohol in the blood and > 15 h since last intake of alcohol;
  8. prior inclusion and participation in the same 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

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

Total oxazepam dosage in milligrams
total oxazepam dosage per subject during detoxification, as determined by Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-Ar) scores
Alcohol intake
Alcohol intake of outpatients, using blood, urine, Timeline Followback and diaries.

Secondary Outcome Measures

Sleep
self-reported sleeping hours
Sleep
self-reported sleeping hours
motor activity
assessed by actigraph
alcohol craving
self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)
alcohol craving
self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)
Mental distress
measured by Hopkins Symptoms Checklist 10 items (SCL-10)
Mental distress
measured by Hopkins Symptoms Checklist 10 items (SCL-10)
patient activity
measured by Patient Activity Measure 13 (PAM-13)
patient activity
measured by Patient Activity Measure 13 (PAM-13)
Socio-emotional recognition
assessed by Reading the mind in the eyes test (RMET)
Socio-emotional recognition
assessed by Reading the mind in the eyes test (RMET)
Socio-emotional recognition
assessed by Reading the mind in the eyes test (RMET)
Facial emotional selective attention
assessed by Visual Dot probe task
Facial emotional selective attention
assessed by Visual Dot probe task
Facial emotional selective attention
assessed by Visual Dot probe task

Full Information

First Posted
August 30, 2016
Last Updated
February 24, 2019
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
NCT02903251
Brief Title
Oxytocin and Alcohol Withdrawal and Dependence
Official Title
Acute and Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: A Prospective Randomized Parallel Group Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
January 22, 2018 (Actual)
Study Completion Date
January 22, 2018 (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 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.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (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 intranasal spray without oxytocin
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.
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.
Primary Outcome Measure Information:
Title
Total oxazepam dosage in milligrams
Description
total oxazepam dosage per subject during detoxification, as determined by Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-Ar) scores
Time Frame
3 days
Title
Alcohol intake
Description
Alcohol intake of outpatients, using blood, urine, Timeline Followback and diaries.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Sleep
Description
self-reported sleeping hours
Time Frame
3 days
Title
Sleep
Description
self-reported sleeping hours
Time Frame
30 days
Title
motor activity
Description
assessed by actigraph
Time Frame
3 days
Title
alcohol craving
Description
self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)
Time Frame
day 3
Title
alcohol craving
Description
self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)
Time Frame
day 30
Title
Mental distress
Description
measured by Hopkins Symptoms Checklist 10 items (SCL-10)
Time Frame
day 3
Title
Mental distress
Description
measured by Hopkins Symptoms Checklist 10 items (SCL-10)
Time Frame
day 30
Title
patient activity
Description
measured by Patient Activity Measure 13 (PAM-13)
Time Frame
day 3
Title
patient activity
Description
measured by Patient Activity Measure 13 (PAM-13)
Time Frame
day 30
Title
Socio-emotional recognition
Description
assessed by Reading the mind in the eyes test (RMET)
Time Frame
Day 2
Title
Socio-emotional recognition
Description
assessed by Reading the mind in the eyes test (RMET)
Time Frame
Day 3
Title
Socio-emotional recognition
Description
assessed by Reading the mind in the eyes test (RMET)
Time Frame
day 30
Title
Facial emotional selective attention
Description
assessed by Visual Dot probe task
Time Frame
Day 2
Title
Facial emotional selective attention
Description
assessed by Visual Dot probe task
Time Frame
Day 3
Title
Facial emotional selective attention
Description
assessed by Visual Dot probe task
Time Frame
day 30

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: At least one prior episode 2 days or longer in duration during which the subject experienced withdrawal symptoms that caused significant incapacitation (e.g., inability to work or do normal activities) OR at least one prior inpatient or outpatient medical detoxification during which the subject exhibited withdrawal symptoms of sufficient magnitude that sedative-hypnotic or anticonvulsant medication was required at least once on 2 consecutive days after cessation of or reduction in the use of alcohol following 2 weeks or more of heavy daily consumption average consumption of 8-30 standard drinks per day for at least 2 weeks prior to enrollment in the study; consenting to participate in the study; have residency in Trøndelag County after discharge Exclusion Criteria: chronic treatment with sedative-hypnotic medications such as benzodiazepines or z-hypnotics; dependence on substances other than alcohol, nicotine or caffeine; inadequately treated, unstable and/or compromising medical or psychiatric conditions; low body weight (BMI < 17) or history of anorexia nervosa or bulimia in the past 2 years; pregnancy; parturition or breast-feeding in the past 6 months; inability to read well enough to complete study questionnaires determined by whether the prospective subject can read the consent form without help and correctly answer basic questions about information in the consent form; no alcohol in the blood and > 15 h since last intake of alcohol; prior inclusion and participation in the same study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trond Jacobsen, MD PhD
Organizational Affiliation
St Olav's University Hospital Trondheim
Official's Role
Study Director
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
Undecided
Citations:
PubMed Identifier
30784955
Citation
Melby K, Grawe RW, Aamo TO, Salvesen O, Spigset O. Effect of intranasal oxytocin on alcohol withdrawal syndrome: A randomized placebo-controlled double-blind clinical trial. Drug Alcohol Depend. 2019 Apr 1;197:95-101. doi: 10.1016/j.drugalcdep.2019.01.003. Epub 2019 Feb 13.
Results Reference
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Oxytocin and Alcohol Withdrawal and Dependence

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