Primary outcomeLeast squares mean· 12 weeks
Proportion of Heavy Drinking Days
| Group | Value (proportion of days per week) | Spread |
|---|---|---|
| Active | 0.3072 | 0.094 |
| Control | 0.5914 | 0.1024 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataOxytocin Treatment of Alcohol Dependence
Short name OTETOH-3
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 22 participants (actual)
- Sponsor
- University of North Carolina, Chapel Hill · Other
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Jul 2015
- Primary completion
- Sept 2016
- Completion
- Sept 2016
- First posted
- 29 Sept 2014 (estimated)
- Last update posted
- 15 Aug 2017
- Conditions
- Alcohol Dependence
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201520162017
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
Interventions
- Intranasal OxytocinDrug
- PlaceboDrug
Arms2
Experimental
Active
Intranasal oxytocin doses 2-3 times/day for 12 weeks
Placebo comparator
Control
Intranasal placebo doses 2-3 times/day for 12 weeks
Primary outcomes2
Outcomes the sponsor listed as primary.
Proportion of Heavy Drinking Days
Time frame · 12 weeks
Registry description
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
Registry description
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.
Secondary outcomes(1)
Alcohol Craving
Time frame · 12 weeks
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeLeast squares mean· 12 weeks
Mean Weekly Drinks Per Drinking Day
| Group | Value (number of drinks per drinking day) | Spread |
|---|---|---|
| Active | 4.8929 | 0.5868 |
| Control | 7.5621 | 0.6108 |
Secondary and other outcome results(1)
Secondary outcomeLeast squares mean· 12 weeks
Alcohol Craving
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Active | 10.8481 | 2.1254 |
| Control | 12.6685 | 2.3122 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ActiveIntranasal oxytocin doses 2-3 times/day for 12 weeks Intranasal Oxytocin: 10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks | 0 / 12 | 0 / 12 | 0 / 12 |
| ControlIntranasal placebo doses 2-3 times/day for 12 weeks Placebo: 10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks | 0 / 10 | 0 / 10 | 2 / 10 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Meeting criteria for DSM-IV-TR alcohol dependence.
* Consumption of at least 35 standard drinks/week for men or 28 standard drinks/week for women for at least 4 consecutive weeks prior to enrollment into the study.
* Women who are able to conceive children and who are sexually active must be on an effective form of birth control such as oral contraceptives, IUDs or the use of condoms with spermicide.
* Competency to give valid informed consent as indicated by a) a Breathalyzer reading at the time the consent form is signed showing an estimated blood alcohol level (BAL) of zero; b) ability to understand the written informed consent form demonstrated by correctly answering questions about the contents of the form after reading the consent form without help (this will also determine whether prospective subjects can read and understand the study questionnaires).
* Ability to get to appointments either through personal or public transportation.
* Ages 18-65.
Exclusion Criteria:
* History of alcohol withdrawal-related seizures, delirium tremens or hallucinations.
* Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g., renal insufficiency, cirrhosis, unstable hypertension, unstable diabetes mellitus, seizure disorder).
* History of psychotic disorder or admission for mania, meeting criteria for an eating disorder in the last 2 years, current moderate or severe major depression, current suicidal ideation.
* Currently meeting DSM-IV TR criteria for dependence on addictive substances other than alcohol except for nicotine or caffeine. Substance abuse disorders are not exclusionary.
* Consumption during the week prior to enrollment or plans to consume during the 12-week trial of benzodiazepines, barbiturates, anticonvulsants or stimulants.
* AST or ALT \> 5 times ULN, bilirubin \> 1.5 X ULN, sodium \< 132 or \> 150 mMol/L, potassium \< 3.2 or \> 5.3 mMol/L.
* Women who are pregnant or breastfeeding.
* Currently participating in or intent to participate in an additional alcohol treatment program during the study period other than Alcoholics Anonymous.
* Court-mandated participation in alcohol treatment or pending incarceration.
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