ACUTE AND LONG-TERM EFFECTS OF OXYTOCIN NASAL SPRAY IN ALCOHOL WITHDRAWAL AND DEPENDENCE: COMPARING TWO GROUPS OF PATIENTS WHERE ONE GROUP RECEIVES PLACEBO SPRAY.

Phase 1

• Conditions: alcohol withdrawal and craving.; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2015-004463-37-NO
• Lead Sponsor: St. Olavs Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-27
• Study Completion: 2017-11-30
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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) age 18-65; 4) consenting to participate in the study; 5) have residency in Sør-Trøndelag County after discharge
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified