Experimental Study on Alcohol Use and Behavior in Young Adults

NCT06199076 | Terminated Phase 2 DMC

• 1 other identifier: 2022-501809-13-01
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Impulsivity using a delay discounting task task measured at both study visits.

  76-80 minutes after administration of the investigational medicinal product.

• Emotion recognition using an emotion recognition task measured at both study visits.

  81-90 minutes after administration of the investigational medicinal product.

• Alcohol craving using an alcohol cue-craving task measured at both study visits.

  91-110 minutes after administration of the investigational medicinal product.

• Social learning using an observational fear learning task measured at both study visits.

  111-120 minutes after administration of the investigational medicinal product.

Study Arms (4)

Oxytocin/Placebo, Alcohol Use Disorder

EXPERIMENTAL

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

Placebo/Oxytocin, Alcohol Use Disorder

EXPERIMENTAL

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

Oxytocin/Placebo, Healthy Control

EXPERIMENTAL

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

Placebo/Oxytocin, Healthy Control

EXPERIMENTAL

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

Interventions

Oxytocin nasal spray DRUG

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.

Also known as: Syntocinon Intranasal Spray

Oxytocin/Placebo, Alcohol Use Disorder; Oxytocin/Placebo, Healthy Control; Placebo/Oxytocin, Alcohol Use Disorder; Placebo/Oxytocin, Healthy Control

Eligibility Criteria

• Age: 18 Years - 24 Years
• Gender Eligibility Details: Self-representation, i.e., sex assigned as male at birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet, Division of Psychology

Solna, Stockholm County, 11777, Sweden

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

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

Study Officials

• Joar Guterstam, PhD, M.D.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, M.D., Psychiatrist

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 10, 2024
• Study Start: October 17, 2023
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)