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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03339024
First Posted: November 9, 2017
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
St. Olavs Hospital
Lade Addiction Treatment Center
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
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).

Condition Intervention Phase
Alcoholism Substance-Related Disorders Drug: intranasal oxytocin spray Other: intranasal spray without oxytocin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: Follow-up of a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Alcohol intake [ Time Frame: 60 days ]
    using self-reported alcohol use (days used and alcohol units)

  • Alcohol intake [ Time Frame: 1 year ]
    using the Timeline Follow-back method and phosphatidylethanol (PEth) blood test


Secondary Outcome Measures:
  • Sleep [ Time Frame: 60 days ]
    self-reported sleeping hours

  • Sleep [ Time Frame: 1 year ]
    self-reported sleeping hours

  • Number of rehospitalisations and readmissions to treatment for substance use disorders [ Time Frame: 1 year ]

Estimated Enrollment: 40
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • participants in the RCT (NCT02903251) who did not complete the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339024


Locations
Norway
Lade Addiction Treatment Center
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Lade Addiction Treatment Center
Investigators
Principal Investigator: Olav Spigset, MD PhD Norwegian University of Science and Technology
  More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03339024     History of Changes
Other Study ID Numbers: 2016/45
2015-004463-37 ( EudraCT Number )
First Submitted: November 7, 2017
First Posted: November 9, 2017
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Oxytocin
Administration, Intranasal
Ethanol
Follow-up Studies

Additional relevant MeSH terms:
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs