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Completed

NCT Number: NCT02903251

Oxytocin and Alcohol Withdrawal and Dependence

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lade Addiction Treatment Center

Trondheim, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intranasal oxytocin spray

Drug

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

intranasal spray without oxytocin

Other

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

Primary outcomes

  1. 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

  2. Alcohol intake

    Time frame: 30 days

    Alcohol intake of outpatients, using blood, urine, Timeline Followback and diaries.

Secondary outcomes

  1. Sleep

    Time frame: 3 days

    self-reported sleeping hours

  2. Sleep

    Time frame: 30 days

    self-reported sleeping hours

  3. motor activity

    Time frame: 3 days

    assessed by actigraph

  4. alcohol craving

    Time frame: day 3

    self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)

  5. alcohol craving

    Time frame: day 30

    self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)

  6. Mental distress

    Time frame: day 3

    measured by Hopkins Symptoms Checklist 10 items (SCL-10)

  7. Mental distress

    Time frame: day 30

    measured by Hopkins Symptoms Checklist 10 items (SCL-10)

  8. patient activity

    Time frame: day 3

    measured by Patient Activity Measure 13 (PAM-13)

  9. patient activity

    Time frame: day 30

    measured by Patient Activity Measure 13 (PAM-13)

  10. Socio-emotional recognition

    Time frame: Day 2

    assessed by Reading the mind in the eyes test (RMET)

  11. Socio-emotional recognition

    Time frame: Day 3

    assessed by Reading the mind in the eyes test (RMET)

  12. Socio-emotional recognition

    Time frame: day 30

    assessed by Reading the mind in the eyes test (RMET)

  13. Facial emotional selective attention

    Time frame: Day 2

    assessed by Visual Dot probe task

  14. Facial emotional selective attention

    Time frame: Day 3

    assessed by Visual Dot probe task

  15. Facial emotional selective attention

    Time frame: day 30

    assessed by Visual Dot probe task

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Lade Addiction Treatment Center
  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2016
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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