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Trial · Interventional

CompletedPhase 3Registry data

Intranasal Oxytocin Effects in Alcohol Withdrawal and Dependence; Follow-up Study

NCTNCT03339024 (opens ClinicalTrials.gov in a new tab)Other id2016/45Other id2015-004463-37Other id2015
Open at ClinicalTrials.govAsk about this trial

Overview

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

Norway

Start
1 Nov 2017
Primary completion
31 Mar 2019
Completion
31 Mar 2019
First posted
9 Nov 2017
Last update posted
19 Feb 2020
Conditions
Alcoholism · Substance-Related Disorders

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020
  1. Ph 3

    Intranasal Oxytocin Effects in Alcohol Withdrawal and Dependence; Follow-up Study

    NCT03339024

    1 Nov 2017 to 31 Mar 2019

Registry summary

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

This study is an assessment of the long-term effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol after 60 days and 1 year. It is a follow-up study of a placebo-controlled randomized controlled study where subjects used oxytocin nasal spray during acute withdrawal and the following 4 weeks in an outpatient setting. Half of the participants have received oxytocin nasal spray, the other half placebo nasal spray (NCT02903251). (added March 2019: 24 patients were available for 1-year follow-up)

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

  • 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. Alcohol intake

    Time frame · 60 days

    Registry description

    using self-reported alcohol use (days used and alcohol units)

  2. Alcohol intake

    Time frame · 1 year

    Registry description

    using the Timeline Follow-back method and phosphatidylethanol (PEth) blood test

Secondary outcomes(3)

  1. Sleep

    Time frame · 60 days

    Registry description

    self-reported sleeping hours

  2. Sleep

    Time frame · 1 year

    Registry description

    self-reported sleeping hours

  3. Number of rehospitalisations and readmissions to treatment for substance use disorders

    Time frame · 1 year

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 · 2020

2 results

Actigraphy assessment of motor activity and sleep in patients with alcohol withdrawal syndrome and the effects of intranasal oxytocin.

Melby et al. 2020PloS onecited by 14

PMID 32053696PMC7018062DOI 10.1371/journal.pone.0228700PUB-32053696

CC BY2 results
Download PDFSee results (2)

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: * participants in the RCT (NCT02903251) who completed the study Exclusion Criteria: * participants in the RCT (NCT02903251) who did not complete the study

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