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Oxytocin and Alcohol Withdrawal and Dependence

NCT02903251 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-02-26

No results posted yet for this study

Summary

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.

Conditions

  • Alcoholism
  • Substance-Related Disorders

Interventions

DRUG

intranasal oxytocin spray

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

intranasal spray without oxytocin

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.

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • Lade Addiction Treatment Center

    collaborator UNKNOWN

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Trond Jacobsen, MD PhD · St Olav's University Hospital Trondheim

  • Olav Spigset, MD PhD · Norwegian University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-01-22
Completion
2018-01-22

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02903251 on ClinicalTrials.gov