Experimental Study on Alcohol Use and Behavior in Young Adults

NCT ID: NCT06199076

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2025-04-23

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.

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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Oxytocin nasal spray

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Oxytocin nasal spray

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Oxytocin nasal spray

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Oxytocin nasal spray

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Syntocinon Intranasal Spray

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Joar Guterstam

PhD, M.D., Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joar Guterstam, PhD, M.D.

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet, Division of Psychology

Solna, Stockholm County, Sweden

Countries

Sweden

Other Identifiers

2022-501809-13-01

Identifier Type: -

Identifier Source: org_study_id