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Halted due to recruitment problems.
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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:
Participants in both groups will on two separate visits perform the following validated behavioral task measures:
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.
Hypotheses:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 76-80 minutes after administration of the investigational medicinal product. |
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Inclusion Criteria:
Alcohol use disorder (AUD) group
Healthy control group
Exclusion Criteria:
Self-representation, i.e., sex assigned as male at birth.
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| Name | Affiliation | Role |
|---|---|---|
| Joar Guterstam, PhD, M.D. | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet, Division of Psychology | Solna | Stockholm County | 11777 | Sweden |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 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. |
| 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. | 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. | 111-120 minutes after administration of the investigational medicinal product. |