Phase 2
Completed N=22
Oxytocin Treatment of Alcohol Dependence
Source: ClinicalTrials.gov NCT02251912 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Proportion of Heavy Drinking Days — 0.3072; 0.5914 proportion of days per week
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Heavy Drinking Days |
0.3072; 0.5914 | — |
| PRIMARY Mean Weekly Drinks Per Drinking Day |
4.8929; 7.5621 | — |
| SECONDARY Alcohol Craving |
10.8481; 12.6685 | — |
Eligibility Criteria
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 150 mMol/L, potassium 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.
Data sourced from ClinicalTrials.gov (NCT02251912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.