Oxytocin and Stress Response in Alcohol Use Disorder
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The neuropeptide oxytocin (OT) increases social approach, trust, and reduces anxiety to social stress.; Saline solution.
Other intervention name(s): Pitocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment