Oxytocin and Alcohol Withdrawal and Dependence

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 22, 2018

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Norwegian University of Science and Technology
  • Collaborator
    • St. Olavs Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Trond Jacobsen, MD PhD, Study Director, St Olav’s University Hospital Trondheim
    • Olav Spigset, MD PhD, Principal Investigator, Norwegian University of Science and Technology

Citations Reporting on Results

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 Apr 1;197:95-101. doi: 10.1016/j.drugalcdep.2019.01.003. Epub 2019 Feb 13.

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