Oxytocin Treatment of Alcohol Dependence (OTETOH-3)
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|ClinicalTrials.gov Identifier: NCT02251912|
Recruitment Status : Completed
First Posted : September 29, 2014
Results First Posted : August 15, 2017
Last Update Posted : August 15, 2017
Purpose: Test whether oxytocin treatment decreases drinking in people who have been consuming alcohol heavily for long periods and are physically and psychologically dependent on alcohol.
Participants: 50 adults with alcohol dependence
Procedures (methods): Oxytocin or placebo will be administered three times a day for the first 2 days followed by twice daily intranasal doses for the rest of the 12 weeks. Before, during and at the end of the trial, each subject will undergo evaluations including breathalyzer readings, rating withdrawal symptoms, interviews about amount of alcohol consumed since last clinic visit, subject self-ratings of anxiety, alcohol craving and, at some visits, laboratory measures (blood and urine) to monitor safety and alcohol/drug use. Following the active phase of the trial, subjects will be followed up at 4 weeks and 12 weeks to evaluate for post-medication safety and efficacy
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence||Drug: Intranasal Oxytocin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Oxytocin Treatment of Alcohol Dependence: A Randomized, Placebo-Controlled Trial|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Intranasal oxytocin doses 2-3 times/day for 12 weeks
Drug: Intranasal Oxytocin
10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks
Other Name: Syntocinon spray
Placebo Comparator: Control
Intranasal placebo doses 2-3 times/day for 12 weeks
10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks
- Proportion of Heavy Drinking Days [ Time Frame: 12 weeks ]Mean proportion of days per week, over the 12-week trial, when subjects drank heavily (5 or more standard drinks for men, 4 or more standard drinks for women).
- Mean Weekly Drinks Per Drinking Day [ Time Frame: 12 weeks ]The mean number of standard drinks (the amount of alcohol in a standard drink is roughly equivalent to the amount of alcohol in a 12 ounce beer) consumed by subjects on days when they drank alcoholic beverages each week averaged over the 12-week trial.
- Alcohol Craving [ Time Frame: 12 weeks ]Mean weekly Penn Alcohol Craving Scale (PACS) scores.The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking as well as the ability to resist drinking. Scores range from: Minimum: 0 Maximum: 30 Lower scores are associated with better outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251912
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Cort A Pedersen, MD||University of North Carolina, Chapel Hill|
|Principal Investigator:||James C Garbutt, MD||University of North Carolina, Chapel Hill|