Oxytocin and Alcohol Withdrawal and Dependence

Phase 3

Completed

• Conditions: Alcoholism; Substance-Related Disorders
• Interventions: Drug: intranasal oxytocin spray; Other: intranasal spray without oxytocin

• Registration Number: NCT02903251
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Study Start: 2016-10
• Primary Completion: 2018-01-22
• Study Completion: 2018-01-22
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-24
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oxytocin	intranasal oxytocin spray	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
Placebo	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lade Addiction Treatment Center; 🇳🇴 Trondheim, Norway