alcohol withdrawal and craving.
Conditions
Interventions
Trade Name: Syntocinon
Product Name: Syntocinon
Pharmaceutical Form: Nasal spray, suspension
Pharmaceutical form of the placebo: Nasal spray, suspension
Route of administration of the placebo: Intrana
Sponsors
St. Olavs Hospital
Eligibility
Sex/Gender
All
Inclusion 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) 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the study is to test whether daily intranasal administration of oxytocin is more effective than placebo in decreasing the oxazepam dosages required to control withdrawal symptoms during a 3-day inpatient program of medical detoxification. ;Secondary Objective: The secondary aims are: 1) test whether daily intranasal administration of oxytocin is more effective than placebo in decreasing CIWA-Ar scores during the detoxification period; 2) test the effects on therapist- and self-reported withdrawal symptoms, dysphoria and Actigraph-assessed akathisia and sleep during the detoxification period; and 3) test whether daily intranasal self-administration of oxytocin is more effective than placebo on alcohol use measures (time to ‘relapse’ and amount, cravings), quality of sleep and mood states during a subsequent 4 week out-patient follow-up period. ;Primary end point(s): Primary endpoint: Phase 1: Milligrams of oxazepam used to complete 3 days of detoxification. Phase 2: Time to ‘relapse’ and amount during 4 weeks of subsequent outpatient treatment. ;Timepoint(s) of evaluation of this end point: Phase 1: at the end of the three-day in-patient stay. Phase 2: after 4 weeks of outpatient treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase 1: CIWA-Ar-score, effects on mood, craving, sleep Phase 2: Effects on therapist- and self-reported withdrawal symptoms, dysphoria and Actigraph-assessed akathisia and sleep. ;Timepoint(s) of evaluation of this end point: Phase 1: at the end of the three-day in-patient stay. Phase 2: after 4 weeks of outpatient treatment. | — |
Countries
Norway
Contacts
Public ContactPI's representative(Katrine Melby)
Lade Behandlingssenter
Outcome results
None listed