Oxytocin Treatment of Alcohol Dependence

NCT02251912 | Completed Phase 2 Results

• 2 other identifiers: 12-1862b1R21AA021927-01A1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Alcohol Dependence

Keywords

Alcohol dependence; Alcohol; Oxytocin; Intranasal administration

Outcome Measures

Primary Outcomes (2)

• Proportion of Heavy Drinking Days

  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).

  12 weeks

• Mean Weekly Drinks Per Drinking Day

  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.

  12 weeks

Secondary Outcomes (1)

• Alcohol Craving

  12 weeks

Study Arms (2)

Active

EXPERIMENTAL

Intranasal oxytocin doses 2-3 times/day for 12 weeks

Drug: Intranasal Oxytocin

Control

PLACEBO COMPARATOR

Intranasal placebo doses 2-3 times/day for 12 weeks

Drug: Placebo

Interventions

Intranasal Oxytocin DRUG

10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks

Also known as: Syntocinon spray

Active

Placebo DRUG

10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Cort Pedersen
• Organization: University of North Carolina at Chapel Hill

cort_pedersen@med.unc.edu

919-923-3284

Study Officials

• Cort A Pedersen, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• James C Garbutt, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: September 29, 2014
• Study Start: July 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 15, 2017
• Results First Posted: August 15, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)