Alcoholism, Substance-Related Disorders
Conditions
Keywords
Oxytocin, Administration, Intranasal, Ethanol
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.
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.
Sponsors
St. Olavs Hospital
Lade Addiction Treatment Center
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total oxazepam dosage in milligrams | 3 days | total oxazepam dosage per subject during detoxification, as determined by Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-Ar) scores |
| Alcohol intake | 30 days | Alcohol intake of outpatients, using blood, urine, Timeline Followback and diaries. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| alcohol craving | day 3 | self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R) |
| Mental distress | day 3 | measured by Hopkins Symptoms Checklist 10 items (SCL-10) |
| Sleep | 3 days | self-reported sleeping hours |
| Socio-emotional recognition | Day 2 | assessed by Reading the mind in the eyes test (RMET) |
| Facial emotional selective attention | Day 2 | assessed by Visual Dot probe task |
| patient activity | day 3 | measured by Patient Activity Measure 13 (PAM-13) |
| motor activity | 3 days | assessed by actigraph |
Countries
Norway
Outcome results
None listed