Substance-Related Disorders Clinical Trial
Official title:
Acute and Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: A Prospective Randomized Parallel Group Placebo-controlled Trial
Verified date | February 2019 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 22, 2018 |
Est. primary completion date | January 22, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Norway | Lade Addiction Treatment Center | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | Lade Addiction Treatment Center, St. Olavs Hospital |
Norway,
Melby K, Gråwe RW, Aamo TO, Salvesen Ø, Spigset O. Effect of intranasal oxytocin on alcohol withdrawal syndrome: A randomized placebo-controlled double-blind clinical trial. Drug Alcohol Depend. 2019 Feb 13;197:95-101. doi: 10.1016/j.drugalcdep.2019.01.00 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Alcohol intake | Alcohol intake of outpatients, using blood, urine, Timeline Followback and diaries. | 30 days | |
Secondary | Sleep | self-reported sleeping hours | 3 days | |
Secondary | Sleep | self-reported sleeping hours | 30 days | |
Secondary | motor activity | assessed by actigraph | 3 days | |
Secondary | alcohol craving | self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R) | day 3 | |
Secondary | alcohol craving | self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R) | day 30 | |
Secondary | Mental distress | measured by Hopkins Symptoms Checklist 10 items (SCL-10) | day 3 | |
Secondary | Mental distress | measured by Hopkins Symptoms Checklist 10 items (SCL-10) | day 30 | |
Secondary | patient activity | measured by Patient Activity Measure 13 (PAM-13) | day 3 | |
Secondary | patient activity | measured by Patient Activity Measure 13 (PAM-13) | day 30 | |
Secondary | Socio-emotional recognition | assessed by Reading the mind in the eyes test (RMET) | Day 2 | |
Secondary | Socio-emotional recognition | assessed by Reading the mind in the eyes test (RMET) | Day 3 | |
Secondary | Socio-emotional recognition | assessed by Reading the mind in the eyes test (RMET) | day 30 | |
Secondary | Facial emotional selective attention | assessed by Visual Dot probe task | Day 2 | |
Secondary | Facial emotional selective attention | assessed by Visual Dot probe task | Day 3 | |
Secondary | Facial emotional selective attention | assessed by Visual Dot probe task | day 30 |
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