NCT03339024

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

November 7, 2017

Last Update Submit

February 16, 2020

Conditions

AlcoholismSubstance-Related Disorders

Keywords

OxytocinAdministration, IntranasalEthanolFollow-up Studies

Outcome Measures

Primary Outcomes (2)

  • Alcohol intake

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

    60 days

  • Alcohol intake

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

    1 year

Secondary Outcomes (3)

  • Sleep

    60 days

  • Sleep

    1 year

  • Number of rehospitalisations and readmissions to treatment for substance use disorders

    1 year

Study Arms (2)

oxytocin

EXPERIMENTAL

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

Drug: intranasal oxytocin spray

Placebo

PLACEBO COMPARATOR

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

Other: intranasal spray without oxytocin

Interventions

intranasal oxytocin sprayDRUG

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.

Also known as: Syntocinon
oxytocin
intranasal spray without oxytocinOTHER

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.

Also known as: placebo
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • participants in the RCT (NCT02903251) who did not complete the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lade Addiction Treatment Center

Trondheim, Norway

Location

Related Publications (1)

  • Melby K, Fasmer OB, Henriksen TE, Grawe RW, Aamo TO, Spigset O. Actigraphy assessment of motor activity and sleep in patients with alcohol withdrawal syndrome and the effects of intranasal oxytocin. PLoS One. 2020 Feb 13;15(2):e0228700. doi: 10.1371/journal.pone.0228700. eCollection 2020.

    PMID: 32053696RESULT

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Olav Spigset, MD PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 9, 2017

Study Start

November 1, 2017

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)