Oxytocin and Alcohol Withdrawal and Dependence
Acute and Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: A Prospective Randomized Parallel Group Placebo-controlled Trial
2 other identifiers
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2016
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2016
CompletedFirst Posted
Study publicly available on registry
September 16, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2018
CompletedFebruary 26, 2019
February 1, 2019
1.3 years
August 30, 2016
February 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total oxazepam dosage in milligrams
total oxazepam dosage per subject during detoxification, as determined by Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-Ar) scores
3 days
Alcohol intake
Alcohol intake of outpatients, using blood, urine, Timeline Followback and diaries.
30 days
Secondary Outcomes (15)
Sleep
3 days
Sleep
30 days
motor activity
3 days
alcohol craving
day 3
alcohol craving
day 30
- +10 more secondary outcomes
Study Arms (2)
oxytocin
EXPERIMENTALintranasal 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 intranasal spray without oxytocin
Placebo
PLACEBO COMPARATORintranasal 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- At least one prior episode 2 days or longer in duration during which the subject experienced withdrawal symptoms that caused significant incapacitation (e.g., inability to work or do normal activities) OR at least one prior inpatient or outpatient medical detoxification during which the subject exhibited withdrawal symptoms of sufficient magnitude that sedative-hypnotic or anticonvulsant medication was required at least once on 2 consecutive days after cessation of or reduction in the use of alcohol following 2 weeks or more of heavy daily consumption
- average consumption of 8-30 standard drinks per day for at least 2 weeks prior to enrollment in the study;
- consenting to participate in the study;
- have residency in Trøndelag County after discharge
You may not qualify if:
- chronic treatment with sedative-hypnotic medications such as benzodiazepines or z-hypnotics;
- dependence on substances other than alcohol, nicotine or caffeine;
- inadequately treated, unstable and/or compromising medical or psychiatric conditions;
- low body weight (BMI \< 17) or history of anorexia nervosa or bulimia in the past 2 years;
- pregnancy; parturition or breast-feeding in the past 6 months;
- inability to read well enough to complete study questionnaires determined by whether the prospective subject can read the consent form without help and correctly answer basic questions about information in the consent form;
- no alcohol in the blood and \> 15 h since last intake of alcohol;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
- Lade Addiction Treatment Centercollaborator
Study Sites (1)
Lade Addiction Treatment Center
Trondheim, Norway
Related Publications (1)
Melby K, Grawe RW, Aamo TO, Salvesen O, Spigset O. Effect of intranasal oxytocin on alcohol withdrawal syndrome: A randomized placebo-controlled double-blind clinical trial. Drug Alcohol Depend. 2019 Apr 1;197:95-101. doi: 10.1016/j.drugalcdep.2019.01.003. Epub 2019 Feb 13.
PMID: 30784955RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Trond Jacobsen, MD PhD
St Olav's University Hospital Trondheim
- PRINCIPAL INVESTIGATOR
Olav Spigset, MD PhD
Norwegian University of Science and Technology
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
August 30, 2016
First Posted
September 16, 2016
Study Start
October 1, 2016
Primary Completion
January 22, 2018
Study Completion
January 22, 2018
Last Updated
February 26, 2019
Record last verified: 2019-02