Clinical trial NCT06199076: Experimental Study on Alcohol Use and Behavior in Young Adults
Official title: Experimental Study on Alcohol Use and Behavior in Young Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alcohol Use Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 206
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Prosocial behavior using a brief 2-trial dictator game task measured at both study visits.
timeFrame: 35-45 minutes after administration of the investigational medicinal product
measure: Prosocial behavior using an extended dictator game task measured at both study visits.
timeFrame: 46-65 minutes after administration of the investigational medicinal product
Secondary outcomes:
measure: Impulsivity using a delay discounting task task measured at both study visits.
timeFrame: 76-80 minutes after administration of the investigational medicinal product.
measure: Emotion recognition using an emotion recognition task measured at both study visits.
timeFrame: 81-90 minutes after administration of the investigational medicinal product.
measure: Alcohol craving using an alcohol cue-craving task measured at both study visits.
timeFrame: 91-110 minutes after administration of the investigational medicinal product.
measure: Social learning using an observational fear learning task measured at both study visits.
timeFrame: 111-120 minutes after administration of the investigational medicinal product.
Other outcomes:
Locations:
city: Solna
country: Sweden
facility: Karolinska Institutet, Division of Psychology
state: Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Joar Guterstam, PhD, M.D.
role: PRINCIPAL_INVESTIGATOR
References: