Laboratory Studies on Oxytocin for Treatment of Alcohol Use Disorder

NCT ID: NCT02407340

Last Updated: 2017-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-06-15

Brief Summary

This study will examine the utility of the neuropeptide oxytocin (OT) as a potential new medication for the treatment of Alcohol use disorder (AUD). Non-treatment seeking men and women with AUD will be enrolled in a double blind placebo controlled phase I clinical trial. Participants will complete an 7-day inpatient protocol. During the first 3 days of the inpatient protocol, participants will complete alcohol abstinence in which withdrawal symptoms are measured,and urine will be collected to determine withdrawal symptom severity and urine levels of the stress hormone cortisol. Participants will then complete 3 laboratory procedures which measure 1) stress response, 2) motivation to drink alcohol and 3) subjective and physiological effects of alcohol. Finally, because participants are individuals with AUD, investigators will administer a brief intervention to address their risky alcohol drinking and problems before discharge.

Detailed Description

This study will lay the necessary groundwork for future comprehensive research to examine the utility of the neuropeptide oxytocin (OT) as a potential new medication for the treatment of Alcohol use disorder (AUD). OT modulates a number of key systems involved in addiction processes, including dopamine (DA) mesolimbic reward circuitry, and hypothalamic-pituitary-adrenal (HPA) axis and corticotrophin-releasing factor (CRF) stress systems, and has low abuse liability. Our overarching hypothesis is that OT will attenuate several measures thought to drive compulsive alcohol drinking and relapse. Specifically, investigators will examine whether OT decreases acute stress responses, alleviates alcohol withdrawal symptoms, reduces craving and motivation to drink, and decreases alcohol self-administration. Since interactions with alcohol are an important focus of our study, investigators will enroll non-treatment seeking heavy drinkers with AUD in a double blind, placebo controlled inpatient protocol. Subjects will be randomized to receive intranasal OT (40 IU/dose) or placebo 3 times daily. Participants will complete alcohol detoxification; investigators will measure alcohol withdrawal symptoms, craving, and 24-hr urinary free CORT. Participants will then complete 3 laboratory procedures in fixed order. The Trier Social Stress Test (TSST) which includes public speaking and performance of mental arithmetic will be used to examine subjective and physiological stress responses. An alcohol motivated responding (AMR) procedure will be used to examine subjects' responding to earn either drinks or money. A cumulative alcohol-dosing (CAD) procedure will be used to examine physiological and subjective responses across several blood alcohol levels. cortisol (CORT) levels will also be assessed. This study will provide new information on OT efficacy across a range of different measures predictive of alcohol use and misuse, and, if OT shows efficacy, help clarify the mechanism of OT action.

Conditions

Alcoholism; Alcohol Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Oxytocin

intranasal oxytocin - 40 International Units (IU) dose administered 3 times daily for 1 week

Group Type: ACTIVE_COMPARATOR

oxytocin

Intervention Type: DRUG

40 international Units (IU) 3xday delivered as 5 sprays (0.1 mL) per nostril

Placebo

Intranasal placebo administered 3 times daily for 1 week

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

5 sprays (0.1 mL) per nostril 3xday; bottles are identical to those of active drug

Interventions

oxytocin

40 international Units (IU) 3xday delivered as 5 sprays (0.1 mL) per nostril

Intervention Type: DRUG

placebo

5 sprays (0.1 mL) per nostril 3xday; bottles are identical to those of active drug

Intervention Type: DRUG

Other Intervention Names

syntocinon; (Na Cl 0.65%, Phenylcarbinol, Benzalkonium Cl)

Eligibility Criteria

Inclusion Criteria

• Healthy 21-50 years old male and female subjects
• Must meet Diagnostic and Statistical Manual (DSM) -V criteria for AUD and not be seeking treatment
• Actively drinking
• Positive blood phosphatidylethanol (PEth) blood test

Exclusion Criteria

• Current DSM-V major current mood or anxiety disorder or drug use disorder (excluding alcohol and nicotine use disorders, and moderate-severe cannabis use disorder); in or in need of treatment
• Drug use in last 30 days and/or positive urine toxicology screens (excluding marijuana)
• History of seizure disorder or closed head trauma
• History of withdrawal-related seizures or serious alcohol withdrawal symptoms
• HIV positive
• Neuroendocrine disorder
• Any serious medical condition that would place subject at risk or interfere with study participation
• Liver function tests more than 3 times normal at screening
• Prescription medications in last 3 months that could affect central nervous system or HPA axis function
• Women who are pregnant, nursing or planning pregnancy cannot participate

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elise Weerts, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IRB00033324

Identifier Type: -

Identifier Source: org_study_id