Oxytocin Treatment of Alcohol Dependence

NCT02275611 | Completed Phase 2 Results DMC

• 1 other identifier: 12-1862a
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will test in individuals who have alcohol dependence (alcohol addiction) the hypotheses 1) that intranasal oxytocin treatment will decrease withdrawal symptoms during medical detoxification and 2) that intranasal oxytocin treatment for 12 weeks in the outpatient setting will decrease drinking.

Conditions

Alcohol Withdrawal; Alcohol Dependence

Keywords

oxytocin; alcohol withdrawal; alcohol dependence; alcoholism

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score

  The Clinical Institute Withdrawal Assessment for Alcohol (CIWA) measure is a ten item measure of alcohol withdrawal symptoms. The CIWA total score is the summation of 10 questions, with a range from 0 (little to no withdrawal) to 67 (worse alcohol withdrawal).

  Change in scores from before initiation of intranasal test treatment and the first 48 hours after initiation of intranasal test treatments

Secondary Outcomes (2)

• Total mg of Lorazepam for Detoxification

  48 hours after initiation of intranasal test doses

• Change in Percentage Heavy Drinking Days

  90 days prior to admission and 4 weeks in the outpatient setting

Study Arms (2)

Intranasal oxytocin spray (Syntocinon Spray)

ACTIVE COMPARATOR

TID inpatient; BID outpatient for 12 wks

Drug: intranasal oxytocin spray

Intranasal Placebo Spray

PLACEBO COMPARATOR

TID inpatient; BID outpatient for 12 wks

Drug: intranasal oxytocin spray; Drug: Intranasal Placebo Spray

Interventions

intranasal oxytocin spray DRUG

Administration of oxytocin in a nasal spray

Also known as: Syntocinon Spray

Intranasal Placebo Spray; Intranasal oxytocin spray (Syntocinon Spray)

Intranasal Placebo Spray DRUG

Intranasal Placebo Spray

Also known as: Placebo

Intranasal Placebo Spray

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Meeting criteria for DSM-IV (Diagnostic and Statistical Manual-IV-TR) alcohol dependence.
• \*2. At least one prior episode of DSM-IV alcohol withdrawal as assessed by SCID Alcohol Dependence Module or scoring \> 6 on the CIWA scale since admission to the inpatient unit, or having any of the following elevated vital signs since admission: pulse \> 110; diastolic blood pressure \> 100; systolic blood pressure \> 160.
• \. At least 12 heavy drinking days in the 28 days prior to enrollment in the study. A heavy drinking day is defined as \>5 standard drinks for men or \>4 standard drinks for women.
• \. Women who are able to conceive children must be on an effective form of birth control such as oral contraceptives, intrauterine devices 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) \<.08 gm/dL (the consent process is repeated when the BAL level has dropped to 0.00 gm/dL) and 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.

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). Clinically significant psychiatric illnesses including any psychotic disorder, bipolar disorder, eating disorder, severe depression, or suicidal ideation.
• \. Chronic or subchronic ( \>3 days in the week prior to admission or outpatient enrollment) treatment with/consumption of benzodiazepines, barbiturates, anticonvulsants or stimulants.
• \. Receipt of \>6 mg of lorazepam or any dose of a long half-life benzodiazepine between admission for medical detoxification and beginning participation in the study (i.e., receiving the first intranasal dose of test treatment).
• \. AST or ALT (liver function tests) \> 5 times ULN (upper level of normal), bilirubin (liver function test) \> 1.5 X ULN, sodium \< 132 or \> 150 mMol/L, potassium \< 3.2 or \> 5.3 mMol/L.
• \. Women who are pregnant or breastfeeding. 8. Intent to participate in an additional alcohol treatment program other than Alcoholics Anonymous 9. Court-mandated participation in alcohol treatment or pending incarceration.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

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 A. Pedersen
• Organization: University of North Carolina at Chapel Hill

Cort_Pedersen@med.unc.edu

(919) 966-4447

Study Officials

• Cort A Pedersem, M.D.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2014
• First Posted: October 27, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-03