Oxytocin and Alcohol Withdrawal and Dependence

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcoholism, Substance-Related Disorders

Intervention / Treatment
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* Drug: intranasal oxytocin spray
* Other: intranasal spray without oxytocin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxytocin<br>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<br>* 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.<br>* Other names: Syntocinon;|
| Placebo Comparator: Placebo<br>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<br>* 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.<br>* Other names: placebo;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxytocin, Administration, Intranasal, Ethanol