Clinical trial NCT02903251: Oxytocin and Alcohol Withdrawal and Dependence
Official title: Acute and Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: A Prospective Randomized Parallel Group Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcoholism
Substance-Related Disorders
Keywords: Oxytocin
Administration, Intranasal
Ethanol
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Lade Addiction Treatment Center
First posted: 2016-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. average consumption of 8-30 standard drinks per day for at least 2 weeks prior to enrollment in the study;
3. consenting to participate in the study;
4. have residency in Trøndelag County after discharge

Exclusion Criteria:

1. chronic treatment with sedative-hypnotic medications such as benzodiazepines or z-hypnotics;
2. dependence on substances other than alcohol, nicotine or caffeine;
3. inadequately treated, unstable and/or compromising medical or psychiatric conditions;
4. low body weight (BMI \< 17) or history of anorexia nervosa or bulimia in the past 2 years;
5. pregnancy; parturition or breast-feeding in the past 6 months;
6. 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;
7. no alcohol in the blood and \> 15 h since last intake of alcohol;
8. prior inclusion and participation in the same study.

Primary outcomes:
measure: Total oxazepam dosage in milligrams
timeFrame: 3 days
measure: Alcohol intake
timeFrame: 30 days
Secondary outcomes:
measure: Sleep
timeFrame: 3 days
measure: Sleep
timeFrame: 30 days
measure: motor activity
timeFrame: 3 days
measure: alcohol craving
timeFrame: day 3
measure: alcohol craving
timeFrame: day 30
measure: Mental distress
timeFrame: day 3
measure: Mental distress
timeFrame: day 30
measure: patient activity
timeFrame: day 3
measure: patient activity
timeFrame: day 30
measure: Socio-emotional recognition
timeFrame: Day 2
measure: Socio-emotional recognition
timeFrame: Day 3
measure: Socio-emotional recognition
timeFrame: day 30
measure: Facial emotional selective attention
timeFrame: Day 2
measure: Facial emotional selective attention
timeFrame: Day 3
measure: Facial emotional selective attention
timeFrame: day 30
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Lade Addiction Treatment Center
Study officials:
affiliation: St Olav's University Hospital Trondheim
name: Trond Jacobsen, MD PhD
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology
name: Olav Spigset, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.