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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004463-37 | EudraCT Number |
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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| Lade Addiction Treatment Center | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxytocin | Experimental | intranasal oxytocin spray Day 1-3: Twice daily intranasal oxytocin spray administered by health personnel. Day 3-30: Self-administered intranasal spray as needed, max thrice daily intranasal spray without oxytocin |
|
| Placebo | Placebo Comparator | intranasal spray without oxytocin Day 1-3: Twice daily intranasal spray without oxytocin, administered by health personnel. Day 3-30: Self-administered intranasal spray as needed, max thrice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intranasal oxytocin spray | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Alcohol intake | Alcohol intake of outpatients, using blood, urine, Timeline Followback and diaries. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep | self-reported sleeping hours | 3 days |
| Sleep | self-reported sleeping hours | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trond Jacobsen, MD PhD | St Olav's University Hospital Trondheim | Study Director |
| Olav Spigset, MD PhD | Norwegian University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lade Addiction Treatment Center | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30784955 | Result | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 22, 2021 | |
| Reset | Jan 28, 2022 | |
| Release | Feb 1, 2022 | |
| Reset | Apr 4, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 22, 2021 | Jan 28, 2022 | |||
| Feb 1, 2022 |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| intranasal spray without oxytocin | Other | 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. |
|
|
| motor activity | assessed by actigraph | 3 days |
| alcohol craving | self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R) | day 3 |
| alcohol craving | self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R) | day 30 |
| Mental distress | measured by Hopkins Symptoms Checklist 10 items (SCL-10) | day 3 |
| Mental distress | measured by Hopkins Symptoms Checklist 10 items (SCL-10) | day 30 |
| patient activity | measured by Patient Activity Measure 13 (PAM-13) | day 3 |
| patient activity | measured by Patient Activity Measure 13 (PAM-13) | day 30 |
| Socio-emotional recognition | assessed by Reading the mind in the eyes test (RMET) | Day 2 |
| Socio-emotional recognition | assessed by Reading the mind in the eyes test (RMET) | Day 3 |
| Socio-emotional recognition | assessed by Reading the mind in the eyes test (RMET) | day 30 |
| Facial emotional selective attention | assessed by Visual Dot probe task | Day 2 |
| Facial emotional selective attention | assessed by Visual Dot probe task | Day 3 |
| Facial emotional selective attention | assessed by Visual Dot probe task | day 30 |
| Apr 4, 2022 |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |