Oxytocin Treatment of Alcohol Withdrawal

NCT01212185 | Completed Phase 1 Results DMC

• 1 other identifier: 09-0172
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, is effective in decreasing alcohol withdrawal symptoms, the number of bouts of withdrawal requiring standard medication treatment (lorazepam) and the amount of lorazepam required to control withdrawal bouts in individuals undergoing medical detoxification. Also, determine rates of subject recruitment and retention in the inpatient setting. Participants: 80 alcohol dependent patients, 18-65 years of age, admitted for medical detoxification. Procedures (methods): Subjects will be inpatients undergoing medical detoxification from alcohol. Oxytocin or placebo will be administered in a nasal spray twice daily in a randomized, double blind manner for three days. Withdrawal symptoms will be measured routinely at q4 hours and prn for length of hospital stay. Lorazepam will be given whenever withdrawal symptoms increase above specific parameters.

Conditions

Alcohol Withdrawal

Keywords

oxytocin; alcohol withdrawal; lorazepam; alcoholism; intranasal administration; CIWA-Ar

Outcome Measures

Primary Outcomes (1)

• Total Lorazepam Dosage (in Milligrams)

  Total lorazepam (in milligrams) required per subject to complete detoxification

  Days 1 to 5

Secondary Outcomes (1)

• CIWA-Ar Scores

  days 1

Study Arms (2)

intranasal spray without oxytocin

PLACEBO COMPARATOR

Twice daily intranasal spray without oxytocin.

Other: intranasal spray without oxytocin

intranasal oxytocin spray

EXPERIMENTAL

Twice daily intranasal oxytocin spray

Drug: intranasal oxytocin spray

Interventions

intranasal oxytocin spray DRUG

6 insufflations (24 IU of oxytocin total) given twice daily for 3 days

Also known as: Syntocinon Spray

intranasal oxytocin spray

intranasal spray without oxytocin OTHER

6 insufflations (0.1 metered dose/insufflation) twice daily

intranasal spray without oxytocin

Eligibility Criteria

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

You may qualify if:

• Daily consumption of 6 or more alcohol drinks/day for at least 2 weeks prior to admission.
• Only one of the following two conditions must be met:
• At least one prior episode 2 days or longer in duration which the subject experienced withdrawal symptoms that caused significant incapacitation.
• At least one prior inpatient or outpatient medical detoxification during which the subject exhibited withdrawal symptoms that sedative-hypnotic or anticonvulsant medication was required at least once on 2 consecutive days after cessation of or reduction in the use of alcohol following 2 weeks or more of heavily daily consumption (6 or more drinks/day).

You may not qualify if:

• Low literacy as indicated by an inability to read and understand the consent form.
• Dependence on substances other than alcohol, nicotine, caffeine or cannabis.
• History of alcohol withdrawal-related seizures, delirium tremens or hallucinations.
• Current or past alcohol-related medical complications (e.g. cirrhosis of the liver, esophageal varices, severe gastritis, hemoptysis, hematochezia or melena).
• Current delirium, disorientation to place or persons, seizures, acute or unstable psychosis or mania.
• Suicidal or homicidal ideation with strong intent, plans or recent attempt.
• Diagnosis of amnesia, dementia, cognitive impairment or significant neurological symptoms.
• Low body weight (BMI\<17).
• History of anorexia nervosa or bulimia in the past 2 years.
• Significant trauma, self injurious behavior or surgery in the previous 2 months
• Pregnancy; giving birth or breast-feeding in the past 6 months.
• Ingestion during the 2 weeks prior to this admission of much more alcohol/day than during previous drinking binges that preceded the onset of alcohol withdrawal symptoms.
• Ingestion of more than 450 ml of alcohol/day.
• Chronic treatment with benzodiazepines, barbiturates, anticonvulsants or stimulants
• Treatment/ingestion in the 72 hours prior to enrollment in the study with long half-life benzodiazepines or sedative hypnotic drugs.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (2)

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Central Regional Hospital

Raleigh, North Carolina, 27603, United States

Location

Related Links

• UNC Department of Psychiatry
• UNC Department of Psychiatry Research

MeSH Terms

Conditions

Alcoholism

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Cort Pedersen
• Organization: UNC_ChapelHill

cort_pedersen@med.unc.edu

919-966-4447

Study Officials

• Cort A Pedersen, M.D.

  The University of North Carolina, Chapel Hill, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 30, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 13, 2014
• Results First Posted: May 13, 2014

Record last verified: 2014-04

Locations

US (2)