Skip to content

Trial · Interventional

CompletedPhase 3Registry data

Oxytocin and Alcohol Withdrawal and Dependence

NCTNCT02903251 (opens ClinicalTrials.gov in a new tab)Other id140682Other id2015-004463-37Other id2015

Overview

Status
Completed
Phase
Phase 3
Enrollment
40 participants (actual)
Sponsor
Norwegian University of Science and Technology · Other
Design
Randomized · Quadruple masking
Countries
1 country

Norway

Start
Oct 2016
Primary completion
22 Jan 2018
Completion
22 Jan 2018
First posted
16 Sept 2016 (estimated)
Last update posted
26 Feb 2019
Conditions
Alcoholism · Substance-Related Disorders

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019
  1. Ph 3

    Oxytocin and Alcohol Withdrawal and Dependence

    NCT02903251

    Oct 2016 to 22 Jan 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • intranasal oxytocin sprayDrug
  • intranasal spray without oxytocinOther

Arms2

  • 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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Total oxazepam dosage in milligrams

    Time frame · 3 days

    Registry description

    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

    Registry description

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

Secondary outcomes(15)
  1. Sleep

    Time frame · 3 days

    Registry description

    self-reported sleeping hours

  2. Sleep

    Time frame · 30 days

    Registry description

    self-reported sleeping hours

  3. motor activity

    Time frame · 3 days

    Registry description

    assessed by actigraph

  4. alcohol craving

    Time frame · day 3

    Registry description

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

  5. alcohol craving

    Time frame · day 30

    Registry description

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

  6. Mental distress

    Time frame · day 3

    Registry description

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

  7. Mental distress

    Time frame · day 30

    Registry description

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

  8. patient activity

    Time frame · day 3

    Registry description

    measured by Patient Activity Measure 13 (PAM-13)

  9. patient activity

    Time frame · day 30

    Registry description

    measured by Patient Activity Measure 13 (PAM-13)

  10. Socio-emotional recognition

    Time frame · Day 2

    Registry description

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

  11. Socio-emotional recognition

    Time frame · Day 3

    Registry description

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

  12. Socio-emotional recognition

    Time frame · day 30

    Registry description

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

  13. Facial emotional selective attention

    Time frame · Day 2

    Registry description

    assessed by Visual Dot probe task

  14. Facial emotional selective attention

    Time frame · Day 3

    Registry description

    assessed by Visual Dot probe task

  15. Facial emotional selective attention

    Time frame · day 30

    Registry description

    assessed by Visual Dot probe task

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2019

4 results

Effect of intranasal oxytocin on alcohol withdrawal syndrome: A randomized placebo-controlled double-blind clinical trial.

Melby et al. 2019Drug and alcohol dependencecited by 30

PMID 30784955DOI 10.1016/j.drugalcdep.2019.01.003PUB-30784955

Full text at the publisher4 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.