Status:
TERMINATED
Experimental Study on Alcohol Use and Behavior in Young Adults
Lead Sponsor:
Karolinska Institutet
Conditions:
Alcohol Use Disorder
Eligibility:
MALE
18-24 years
Phase:
PHASE2
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 con...
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 rec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2025
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT06199076
Start Date
October 17 2023
End Date
April 23 2025
Last Update
May 7 2025
Active Locations (1)
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1
Karolinska Institutet, Division of Psychology
Solna, Stockholm County, Sweden, 11777