Oxytocin and Alcohol Withdrawal and Dependence

Acute and Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: A Prospective Randomized Parallel Group Placebo-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders; Alcoholism
• Intervention / Treatment: Drug: intranasal oxytocin spray; Other: intranasal spray without oxytocin

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • Lade Addiction Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 intranasal spray without oxytocin	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.; Other Names: Syntocinon
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	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.; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total oxazepam dosage in milligrams	total oxazepam dosage per subject during detoxification, as determined by Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-Ar) scores	3 days
Alcohol intake	Alcohol intake of outpatients, using blood, urine, Timeline Followback and diaries.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep	self-reported sleeping hours	3 days
Sleep	self-reported sleeping hours	30 days
motor activity	assessed by actigraph	3 days
alcohol craving	self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)	day 3
alcohol craving	self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)	day 30
Mental distress	measured by Hopkins Symptoms Checklist 10 items (SCL-10)	day 3
Mental distress	measured by Hopkins Symptoms Checklist 10 items (SCL-10)	day 30
patient activity	measured by Patient Activity Measure 13 (PAM-13)	day 3
patient activity	measured by Patient Activity Measure 13 (PAM-13)	day 30
Socio-emotional recognition	assessed by Reading the mind in the eyes test (RMET)	Day 2
Socio-emotional recognition	assessed by Reading the mind in the eyes test (RMET)	Day 3
Socio-emotional recognition	assessed by Reading the mind in the eyes test (RMET)	day 30
Facial emotional selective attention	assessed by Visual Dot probe task	Day 2
Facial emotional selective attention	assessed by Visual Dot probe task	Day 3
Facial emotional selective attention	assessed by Visual Dot probe task	day 30

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; Lade Addiction Treatment Center
• Investigators: Study Director: Trond Jacobsen, MD PhD, St Olav's University Hospital Trondheim

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): January 22, 2018
• Study Completion (Actual): January 22, 2018

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 24, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Ethanol; Oxytocin; Administration, Intranasal
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 140682; 2015-004463-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No