Oxytocin and Stress Response in Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title: Impact of Oxytocin on Neurobiologic Substrates of Social Stress in Individuals With Alcohol Use Disorder

Status Completed

Clinical Trial Summary

Individuals with alcohol use disorder (AUD) will complete one functional Magnetic Resonance Imaging (fMRI) scanning visit. Prior to the scan, individuals will receive a nasal spray of either 24 international units (IU) of oxytocin (OT), or placebo (PBO). During the scan, they will perform the Montreal Imaging Stress Task (MIST), a social stress task. Subjective craving and anxiety data will be collected.

Clinical Trial Description

Participants: Twenty-four individuals with AUD will be recruited through the Clinical Intake and Assessment (CIA) Core of the Alcohol Research Center (ARC). Screening and basic assessments will be conducted by the CIA Core to determine eligibility and suitability for participation in this pilot project. Each individual will sign an Institutional Review Board (IRB)-approved informed consent form.

Study Visit Assessments: The Drinking Motives Questionnaire Revised will be used to assess motivation for drinking across four subscales: (1) coping motives; (2) social motives; (3) conformity motives; and (4) enhancement motives. The Form 90 will be used to assess daily alcohol consumption in the 90 days prior to the study visit and the time from last drink . A modification of the Within Session Rating Scale will be used to assess craving and mood.

Study Visit Procedures: Participants will be asked to arrive at the Addiction Sciences Division on the study visit day. Female participants will have their urine tested for pregnancy. Females who test positive for pregnancy will be excluded. All participants will be tested for drugs of abuse and alcohol. Patients testing positive for drugs, with the exception of marijuana, will be excluded; patients testing positive for alcohol may be re-scheduled. Participants will be asked about substance use in the last 90 days and will fill out the Drinking Motives Questionnaire. Subjects who have not had a research physical exam within the last 30 days will have a physical completed. They will then be escorted to the scanner at 30 Bee Street.

The study will use a double-blind placebo controlled design. Intranasal OT (n=12) or PBO (n=12) sprays will be administered at 11:30 am, approximately 45 min prior to the scanning session. This dose and timing of OT administration were selected based on the literature.

MIST Procedure: The study will use a block design of three, 6-min runs separated by 2-min of rest for feedback, for a total of 24 min. During each run, participants will be exposed to 40-sec blocks of three different conditions (rest, control, and experimental). Prior to the task, participants will are shown images of what the screen will look like during each condition. The participants will be instructed to relax during the rest condition and focus on the screen. During the control condition, the participants will be asked to answer math problems as accurately as possible but will also be told that their responses will not be recorded. During the experimental condition, the participants will be asked to perform the math task as quickly and accurately as possible. A performance bar located on the screen will allow them to see their performance as compared to an "average" person. The participants will be told that the average person would answer about 85% of the problems correctly; however, the program limits the participants' performance rate to between 35-45%. A time limit will be enforced throughout the experimental condition. After each run, the participants will be given negative feedback from the investigator.

Blood Oxygen Level Dependent (BOLD)-fMRI Procedure: Data will be acquired on a Siemens Trio 3T scanner in MUSC's Center for Biomedical Imaging. For co-registration and normalization of functional images, a high resolution T1-weighted Magnetization-Prepared Rapid Acquisition with Gradient Echo (MPRAGE) anatomical image will be acquired with the following parameters: Time of Repetition (TR)= 2100 ms, Echo Time (TE)= 4.18 ms, flip angle= 12°, field of view= 256 mm, slice thickness= 1.0 mm. The scanning planes will be oriented parallel to the anterior commissure-posterior commissure line. Participants will be asked to relax and keep their eyes opened and fixed on a cross-hair for 6 min while resting state data are collected. Participants will then complete the MIST. T2*-weighted gradient-echo planar images (EPI) will be acquired with the following parameters: TR= 2000 ms, TE= 27 ms, flip angle= 76º, matrix 64 x 64, field of view= 23 cm, slice thickness= 3.7 mm with no gap, with 36 slices to cover the entire brain. ;

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Disease

• NCT number: NCT03610633
• Study type: Interventional
• Source: Medical University of South Carolina
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Completion date: September 2018