Experimental Study on Alcohol Use and Behavior in Young Adults (OXYCAC)

The goal of this double blind randomized placebo-controlled clinical trial is to compare intranasal oxytocin and placebo in young adult individuals with alcohol use disorder as compared to healthy controls. The main questions it aims to answer are:

• The effect of oxytocin versus placebo on prosocial behavior in individuals with high- versus low alcohol use
• The effect of oxytocin versus placebo on impulsivity, emotion recognition, social learning, and alcohol craving in individuals with high- versus low alcohol use

Participants in both groups will on two separate visits perform the following validated behavioral task measures:

• Dictator game tasks assessing prosocial behavior
• Delay discounting task assessing impulsivity
• Emotion recognition task assessing emotion recognition
• Alcohol cue craving task assessing alcohol craving
• Observational fear learning task assessing social learning

Researchers will compare groups of high and low alcohol use to see if there is a difference in effect of oxytocin versus placebo between groups.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Drug: Oxytocin nasal spray

Detailed Description

Hypotheses:

1. OXT vs. placebo will improve the deficits in prosocial behavior in individuals with AUD vs. HC,
2. OXT vs. placebo will improve the deficits in impulsivity, difficulties in emotion recognition and social learning in AUD vs. HC
3. OXT vs. placebo will reduce craving for alcohol, in individuals AUD vs. HC

Material and Methods:

The study will include young adults (18-24 years old): 110 individuals with AUD and 110 healthy controls (HC) matched on gender, education, and age. Sample size estimation is based on effect sizes from previous studies investigating prosocial behavior in addiction, and studies on the influence of OXT on social cognition respectively.

Both groups will undergo thorough psychiatric assessment before inclusion and eligible participants will be invited to a two-session laboratory study (2 weeks apart) randomized for the order of administration of the study compound. On the planned test day after controlling for alcohol and drug use, intranasal OXT and matching placebo at a dose of 24IU will be administered. Behavioral tasks previously developed in our laboratory and evaluated in AUD populations to identify social cognitive impairments in terms of prosocial behavior and emotion recognition will be utilized. In addition, validated behavioral measure of impulsivity, namely the Delay discounting task will be used and craving will be assessed by a standardized assessment battery developed by our laboratory which includes a combination of a standardized questionnaire and visual cues comprising images of alcohol and people drinking.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Simon Jangard, MSc, Psych.; Phone Number: 0046702935980; Email: simon.jangard@ki.se
• Study Contact Backup: Name: Joar Guterstam, PhD, M.D.; Phone Number: 0046812347336; Email: joar.guterstam@ki.se

Study Locations

• Sweden
  • Stockholm
    • Solna, Stockholm, Sweden, 11777
      • Recruiting
      • Karolinska Institutet, Division of Psychology
      • Contact: Joar Guterstam, PhD, M.D.; Phone Number: 0046812347336; Email: joar.guterstam@ki.se
      • Contact: Simon Jangard, M.Sc., Psych; Phone Number: 0046702935980; Email: simon.jangard@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18-24 years of age
• Male
• Give informed consent and comply with study procedure
• Understands written Swedish

Alcohol use disorder (AUD) group

• Fulfils criteria for at least moderate AUD the past 12 months according to MINI Neuropsychiatric Interview
• Fulfils at least 8 points on the Alcohol Use Disorder Identification Test

Healthy control group

• No criteria for AUD the past 12 months according to MINI Neuropsychiatric Interview
• Fulfils less than 8 points on the Alcohol Use Disorder Identification Test

Exclusion Criteria:

• Fulfils criteria for any substance use disorder (except AUD for AUD-group, and mild cannabis- and nicotine use disorder for both groups).
• Using cocaine, amphetamines, hallucinogens, benzodiazepines, etc. within 1 month of the start of the study (excluding cannabis)
• Cannabis use more than 2 days in past month
• Cannabis use on day of testing or day before testing
• Traces of alcohol as measured by breathalyzer on the day of testing
• History of severe psychiatric disorder (e.g. severe depression, bipolar, antisocial personality disorder) or neuropsychiatric disorder of ADHD, autism or Tourette's.
• Medical conditions of such severity that they require continual clinical attention, such as regular follow-up visits, prescribed medications or other specific treatment
• Prescription medicine the past 3 months
• Using non-prescription medicine that could not be stopped 48 hours prior to each visit
• Using intranasal medicine that could not be stopped 48 hours prior to each visit
• Prescription medicine the past 3 months
• Allergy or intolerance to preservatives in nasal spray, e.g. latex allergy.
• Upper-respiratory tract infection (i.e. a 'common cold' resulting in significant nasal congestion) at day of testing (but with the possibility of rescheduling for another time point)
• History of nasal disease (e.g. atrophic rhinitis, recurrent nose bleeds), nose damage (e.g. broken nose), and nasal surgery
• History of head trauma (i.e. loss of consciousness longer than 2 minutes)
• Simultaneous participation in another clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxytocin/Placebo, Alcohol Use Disorder; Visit 1: Alcohol Use Disorder participants will receive 24 IU of oxytocin prior to completing behavioral task measures Visit 2: Alcohol Use Disorder participants will receive 24 IU of placebo (saline solution) prior to completing behavioral task measures	Drug: Oxytocin nasal spray; The clinical trial is a phase II-study double-blind placebo-controlled study. The trial will have a parallel group cross-over design where subjects with alcohol use disorder versus healthy controls will administer a single dose of intranasal oxytocin versus placebo on two study visits 1-3 weeks apart.; Other Names: Syntocinon Intranasal Spray
Experimental: Placebo/Oxytocin, Alcohol Use Disorder; Visit 1: Alcohol Use Disorder participants will receive 24 IU of placebo (saline solution) prior to completing behavioral task measures Visit 2: Alcohol Use Disorder participants will receive 24 IU of oxytocin prior to completing behavioral task measures	Drug: Oxytocin nasal spray; The clinical trial is a phase II-study double-blind placebo-controlled study. The trial will have a parallel group cross-over design where subjects with alcohol use disorder versus healthy controls will administer a single dose of intranasal oxytocin versus placebo on two study visits 1-3 weeks apart.; Other Names: Syntocinon Intranasal Spray
Experimental: Oxytocin/Placebo, Healthy Control; Visit 1: Healthy Control participants will receive 24 IU of oxytocin prior to completing behavioral task measures Visit 2: Healthy Control participants will receive 24 IU of placebo (saline solution) prior to completing behavioral task measures	Drug: Oxytocin nasal spray; The clinical trial is a phase II-study double-blind placebo-controlled study. The trial will have a parallel group cross-over design where subjects with alcohol use disorder versus healthy controls will administer a single dose of intranasal oxytocin versus placebo on two study visits 1-3 weeks apart.; Other Names: Syntocinon Intranasal Spray
Experimental: Placebo/Oxytocin, Healthy Control; Visit 1: Healthy Control participants will receive 24 IU of placebo (saline solution) prior to completing behavioral task measures Visit 2: Healthy Control participants will receive 24 IU of oxytocin prior to completing behavioral task measures	Drug: Oxytocin nasal spray; The clinical trial is a phase II-study double-blind placebo-controlled study. The trial will have a parallel group cross-over design where subjects with alcohol use disorder versus healthy controls will administer a single dose of intranasal oxytocin versus placebo on two study visits 1-3 weeks apart.; Other Names: Syntocinon Intranasal Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prosocial behavior using a brief 2-trial dictator game task measured at both study visits.	Prosocial behavior using a Dictator game task previously developed and evaluated for a alcohol use disorder population. Subjects are informed that they will be anonymous and play online with other anonymous interaction partners. The subject is asked to decide and indicate their distribution of points for oneself and/or another subject. Prosocial behavior will be operationalized as the points transferred to the other subjects on each trial. Time approx: 5 minutes.	35-45 minutes after administration of the investigational medicinal product
Prosocial behavior using an extended dictator game task measured at both study visits.	Prosocial behavior using a Dictator game task previously developed and evaluated for assessing the effect of oxytocin on prosocial behavior. Subjects are informed that they will be anonymous and play online with other anonymous interaction partners. The subject is asked to decide and indicate their preference regarding the distribution of points for oneself and/or another subject. Prosocial behavior will be operationalized as the proportional preference of self/other point distribution. Time approx: 15 minutes.	46-65 minutes after administration of the investigational medicinal product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impulsivity using a delay discounting task task measured at both study visits.	The subject decides on whether to keep a smaller number of points today, or a larger number of points in the future operationalized as the discounting rate. Time approx: 5 minutes.	76-80 minutes after administration of the investigational medicinal product.
Emotion recognition using an emotion recognition task measured at both study visits.	The subject identifies the correct emotion from a set facial expression images. Time approx: 10 minutes.	81-90 minutes after administration of the investigational medicinal product.
Alcohol craving using an alcohol cue-craving task measured at both study visits.	The subject is in separate steps presented with alcohol cues for their preferred beverage (e.g. beer or wine) with increasing intensity while alcohol craving being measured using the Alcohol Urge Questionnaire. Time approx: 10 minutes.	91-110 minutes after administration of the investigational medicinal product.
Social learning using an observational fear learning task measured at both study visits.	The subject observes a video of an allegedly previous subject receiving mild electric stimulation in conjunction to watching some colored squares on a screen while skin conductance is being measured. Time approx: 5 minutes.	111-120 minutes after administration of the investigational medicinal product.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Joar Guterstam, PhD, M.D., Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 27, 2023
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 2022-501809-13-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No