Alcohol Use DisorderPhase 2OXYCACNCT06199076
Experimental Study on Alcohol Use and Behavior in Young Adults
A Phase 2 study testing Oxytocin nasal spray in people with Alcohol Use Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Oxytocin nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteSweden
- Study dates
- 17 Oct 2023to 23 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Division of Psychology
Solna, Stockholm County, 11777
About this study
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
Read more
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.
Read the detailed description
Hypotheses:
- OXT vs. placebo will improve the deficits in prosocial behavior in individuals with AUD vs. HC,
- OXT vs. placebo will improve the deficits in impulsivity, difficulties in emotion recognition and social learning in AUD vs. HC
- 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
- Being tested
- Oxytocin nasal spray
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
Also called Syntocinon Intranasal 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Oxytocin nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 111-120 minutes after administration of the investigational medicinal product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start17 Oct 2023
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Why it stopped: Halted due to recruitment problems.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joar Guterstam, Karolinska Institutet
- Investigators
- Joar Guterstam, PhD, M.D., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199076
- Sponsor's protocol ID
- 2022-501809-13-01
- Acronym
- OXYCAC
- Status last verified
- Apr 2025
- First submitted
- 13 Dec 2023
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Study on Alcohol Use and Behavior in Young Adults
- ClinicalTrials.gov ID
- NCT06199076
- Acronym / sponsor ID
- OXYCAC / 2022-501809-13-01
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted due to recruitment problems.
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- OXT vs. placebo will improve the deficits in prosocial behavior in individuals with AUD vs. HC,
- OXT vs. placebo will improve the deficits in impulsivity, difficulties in emotion recognition and social learning in AUD vs. HC
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oxytocin/Placebo, Alcohol Use Disorder | Experimental | Drug: Oxytocin nasal sprayVisit 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 |
| Placebo/Oxytocin, Alcohol Use Disorder | Experimental | Drug: Oxytocin nasal sprayVisit 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 |
| Oxytocin/Placebo, Healthy Control | Experimental | Drug: Oxytocin nasal sprayVisit 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 |
| Placebo/Oxytocin, Healthy Control | Experimental | Drug: Oxytocin nasal sprayVisit 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 |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 18-24 years of age
- Male
- Give informed consent and comply with study procedure
- Understands written Swedish
- Alcohol use disorder (AUD) group
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin nasal sprayAlso: Syntocinon Intranasal SprayThe 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. | Drug | Oxytocin/Placebo, Alcohol Use Disorder, Oxytocin/Placebo, Healthy Control, Placebo/Oxytocin, Alcohol Use Disorder, Placebo/Oxytocin, Healthy Control |
Primary outcome
Prosocial behavior using a brief 2-trial dictator game task measured at both study visits.
Time frame: 35-45 minutes after administration of the investigational medicinal product
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.
Prosocial behavior using an extended dictator game task measured at both study visits.
Time frame: 46-65 minutes after administration of the investigational medicinal product
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.
4 secondary outcomes
Impulsivity using a delay discounting task task measured at both study visits.
Time frame: 76-80 minutes after administration of the investigational medicinal product.
Emotion recognition using an emotion recognition task measured at both study visits.
Time frame: 81-90 minutes after administration of the investigational medicinal product.
Alcohol craving using an alcohol cue-craving task measured at both study visits.
Time frame: 91-110 minutes after administration of the investigational medicinal product.
Social learning using an observational fear learning task measured at both study visits.
Time frame: 111-120 minutes after administration of the investigational medicinal product.
Results and safety
The study was stopped early (reason given: Halted due to recruitment problems.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joar Guterstam, PhD, M.D. principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin nasal spray in people with Alcohol Use Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Halted due to recruitment problems.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosocial behavior using a brief 2-trial dictator game task measured at both study visits. (time frame: 35-45 minutes after administration of the investigational medicinal product). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.