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Completed

NCT Number: NCT03339024

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

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)

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

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

  • participants in the RCT (NCT02903251) who completed the study

Exclusion criteria

  • participants in the RCT (NCT02903251) who did not complete the 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 Day 30 - 12 months: No further oxytocin treatment, i.e. treatment-as-usual.

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 Day 30 - 12 months: No further oxytocin treatment, i.e. treatment-as-usual.

Other names: placebo

Primary outcomes

  1. Alcohol intake

    Time frame: 60 days

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

  2. Alcohol intake

    Time frame: 1 year

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

Secondary outcomes

  1. Sleep

    Time frame: 60 days

    self-reported sleeping hours

  2. Sleep

    Time frame: 1 year

    self-reported sleeping hours

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

    Time frame: 1 year

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

Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: Follow-up of a Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2017
Registry last updated
Feb 19, 2020

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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