Oxytocin and Alcohol Withdrawal and Dependence

Substance-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903251
• Other study ID #: 140682
• Secondary ID: 2015-004463-37
• Status: Completed
• Phase: Phase 3
• Start date: October 2016
• Est. completion date: January 22, 2018

Study information

• Verified date: February 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 22, 2018
• Est. primary completion date: January 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholism
• Substance-Related Disorders

Intervention

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:
• 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.

Locations

Country	Name	City	State
Norway	Lade Addiction Treatment Center	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Lade Addiction Treatment Center, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Melby K, Gråwe RW, Aamo TO, Salvesen Ø, Spigset O. Effect of intranasal oxytocin on alcohol withdrawal syndrome: A randomized placebo-controlled double-blind clinical trial. Drug Alcohol Depend. 2019 Feb 13;197:95-101. doi: 10.1016/j.drugalcdep.2019.01.00 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Alcohol intake	Alcohol intake of outpatients, using blood, urine, Timeline Followback and diaries.	30 days
Secondary	Sleep	self-reported sleeping hours	3 days
Secondary	Sleep	self-reported sleeping hours	30 days
Secondary	motor activity	assessed by actigraph	3 days
Secondary	alcohol craving	self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)	day 3
Secondary	alcohol craving	self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)	day 30
Secondary	Mental distress	measured by Hopkins Symptoms Checklist 10 items (SCL-10)	day 3
Secondary	Mental distress	measured by Hopkins Symptoms Checklist 10 items (SCL-10)	day 30
Secondary	patient activity	measured by Patient Activity Measure 13 (PAM-13)	day 3
Secondary	patient activity	measured by Patient Activity Measure 13 (PAM-13)	day 30
Secondary	Socio-emotional recognition	assessed by Reading the mind in the eyes test (RMET)	Day 2
Secondary	Socio-emotional recognition	assessed by Reading the mind in the eyes test (RMET)	Day 3
Secondary	Socio-emotional recognition	assessed by Reading the mind in the eyes test (RMET)	day 30
Secondary	Facial emotional selective attention	assessed by Visual Dot probe task	Day 2
Secondary	Facial emotional selective attention	assessed by Visual Dot probe task	Day 3
Secondary	Facial emotional selective attention	assessed by Visual Dot probe task	day 30