An interventional study of CT- optimal Robotic skin stimulation and Non-CT-optimal Robotic skin stimulation in Alcohol Use Disorder, sponsored by Aalto University. Completed at 1 site in Finland. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Aalto University · Not applicable, Interventional, and Basic science
The aim of this trial is to investigate the effect of the activation of C-tactile afferents (CT) on relapse predicting biomarkers and subjective alcohol craving in alcohol use disorder (AUD) patients.
To test this in a laboratory environment, we will investigate the acute and chronic effect of mechanic CT activation vs. non-CT-activating control condition during exposure to validated craving-inducing visual stimuli in patients with AUD.We will assess several physiological measures that have been previously shown to indicate craving and predict relapse in patients with substance use disorder. These measures include pupillary reactivity, electroencephalography (EEG), salivary cortisol level and heart rate variability (HRV). These measures, together with the ratings of subjective craving, will be the primary endpoints of the investigation.
Primary objective is to test the hypothesis that CT activation may have therapeutic potential in treatment of AUD. Secondary objective is to investigate the safety and tolerability of mechanic optimal CT activation and its feasibility on modulation of certain biomarkers in AUD population.
40 early abstinent (≥ 2 weeks) female and male individuals of 18 to 60 years of age who meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for mild to moderate AUD and who commonly engage in heavy alcohol consumption. However, the participants should precede two weeks of abstinence.
The study will include two experiments (Experiment 1. and Experiment 2.) that are conducted during two separate study visits with maximum seven days in between the visits.
Experiment 1. - Stress-related biomarkers in cue-, stress- and neutral stimuli exposure.
Experiment 1 aims to assess HPA-axis and autonomic nervoussystem reactivity before, during and after exposure to alcohol-, stress-, and neutral visual stimuli while either CT-optimal or non-CT-optimal robotic skin stimulation is provided. The primary biomarkers that will be monitored during the experiment are blood volume pulse (BVP), from which heart rate variability (HRV) will be derived from, and salivary cortisol level. In addition, self-reposted alcohol craving will be measuren with visual analog scale.
Five salivary cortisol samples will be collected at time points -20, -5, 0, +10 and +25. HRV will be derived from BVP and analysed with Kubios HRV Premium software.
All three visual stimuli conditions (neutral, alcohol and stress) will be given during the first study visit.
Experiment 2 - Cue-reactivity task test
In the cue-reactivity task pupillary reactivity, event related potentials (EVP's) of EEG will be measured during alcohol-related and neutral visual stimuli while the CT-optimal or non-CT-optimal skin stimulation is provided. Subjective craving will be self-reported by rating it on a 5-point VAS after each alcohol-related image.
The experiment will take place in an electrically shielded room provided by Aalto Behavioral Laboratory. The pupillary reactivity tracking and the EEG measuring systems will be connected to the PC providing the visual stimuli and the following tasks.
Two types of stimuli - 48 alcohol-related and 48 neutral images - will be presented so that each alcohol related image will be followed by a neutral image. The images will be centered on a white background and the colour, size and brightness of the alcohol and neutral stimuli will be matched. ). After each neutral image, the subject will be presented a question about the predominant colour in the image, which they will answer with the response pad. Once the subject has responded, the next stimulus image will be presented. The trial and the EEG and pupillometry recordings will finnish when the subject has responded to all images. In the end of the laboratory session, the subject will go through a relapse prevention session with an addiction medicine specialist to ensure that the distress caused by the experiments will not trigger a relapse outside of the laboratory.
Relapse prevention sessions
In both experiments the subjects will go through a relapse prevention session with an experienced addiction medicine specialist. The relapse prevention session will take place at the end of each laboratory session, after the exposure to the stimuli. The session consists of short motivational enhancement counselling designed to prevent relapsing.
Follow-up
The experiments will be followed by a two-week period during which the participant will report subjective craving, alcohol consumption and possible adverse events by filling an online diary (Appendix 6). If the participant does not have access to the internet, the diary may be filled manually.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's enrollment of 21 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
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Exclusion Criteria:
5. Subjects with current use of any other addictive substances (excluding nicotine).
6. The subject has been treated with any medicinal product within 30 days.
7. The subject is currently participating or has recently (4 weeks prior to the Visit 1) participated in a treatment program for alcohol use disorders. 8. Dermatological conditions, especially on the targeted anatomical area. E.g., sun burns, cuts, eczema and fungal or other contagious skin diseases.
9. The subject has a untreated and unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance or chronic atrial fibrillation.
10. Current use of systemic 11. Autism spectrum disorder (ASD). Score 26 or more in The Autism-Spectrum Quotient test.
13. The subject reports treatment, either current or within 28 days prior to the online screening, with any medications having a potential effect on alcohol consumption and related behaviours or mood. These include opiate antagonists (e.g., naltrexone, Vivitrol, Selincro), glutamate antagonists (e.g., acamprosate), anticonvulsants (e.g., topiramate), serotonin reuptake inhibitors (e.g., fluoxetine), serotonin antagonists (e.g., buspirone), other antidepressants (e.g., tricyclic antidepressants or monoamine oxidase inhibitors), dopamine antagonists (e.g., haloperidol), and disulfiram (Antabuse).
14. Current abuse of benzodiazepines. Benzodiazepines are allowed if used chronically.
15. Pregnancy by information given by the patient (non-invasive study). 16. Any other condition or therapy that in the investigator's opinion may pose a risk to the subject, prevent the subject from completing the required study procedures or interfere with the study objectives.
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The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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Clinically significant
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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The active treatment is CT-optimal slow (3 cm/s) stroking tactile stimulation produced with a mechanically moving cosmetic brush
Device: CT- optimal Robotic skin stimulation
The non-CT-optimal control treatment is performed with velocity of 0.1-0.2 cm/s and a force similar to the CT-optimal treatment with same robotic device as the Ct-optimal treatment.
Device: Non-CT-optimal Robotic skin stimulation
To eliminate the social aspect present in human touch, we use a robotic device to provide the CT-optimal dynamic touch. Both CT-optimal touch treatment and the non-CT-optimal control treatment are performed with the same custom made robotic device provides dynamic back-and forth strokes with a soft cosmetic brush on the skin of the non-dominant forearm of the participants. The CT-optimal treatment is performed at a velocity of 2.5-3 cm/s and a force of 200-300 mN. The non-CT-optimal control treatment is performed with velocity of 0.1-0.2 cm/s and a force similar to the CT-optimal treatment. The device is visible to the participants during the experiment.
Also known as: Robotic CT-optimal touch, CT-optimal skin stimulation, CT-optimal stimulation, CT-optimal tactile stimulatin
To eliminate the social aspect present in human touch, we use a robotic device to provide the CT-optimal dynamic touch. Both CT-optimal touch treatment and the non-CT-optimal control treatment are performed with the same custom made robotic device provides dynamic back-and forth strokes with a soft cosmetic brush on the skin of the non-dominant forearm of the participants. The CT-optimal treatment is performed at a velocity of 2.5-3 cm/s and a force of 200-300 mN. The non-CT-optimal control treatment is performed with velocity of 0.1-0.2 cm/s and a force similar to the CT-optimal treatment. The device is visible to the participants during the experiment.
Also known as: Non-CT-optimal touch
Heart rate variability (HRV) reactivity as a biomarker of stress and a predictor of susceptibility to relapse
To assess autonomic functioning, Standard deviation of normal-to-normal intervals (SDNN) HRV (ms) is derived from blood volume pulse (BVP) measured with Empatica E4 wrist band device throughout Experiment 1. excluding a 15-minute relaxation at the end of the experimental session.
Time frame: Measurement taken during each participant's first study visit for approximately 32 minutes.
Self-reported Alcohol craving
In the experiment performed during the first study visit a visual analog scale to assess self-reported subjective craving is shown before and after each cue exposure. The guestion "If alcohol was available to me right now..." is shown with a ten-point scale in which 1 = I would not want to drink it at all, 10 = I would not be able to resist drinking even if I tried. In the experiment at the second study visit a five-point visual analog scale for rating the alcohol craving is shown after each alcohol-related image in the cue reactivity task. In this on the queston is "How willing are you to drink the drink in the previous image…" 1 = I would not want to drink it at all, 5 = I would not be able to resist drinking even if I tried.
Time frame: The first and second study visits. Maximum 7 days in between the visits.
Salivary cortisol as a biomarker of stress and a predictor of susceptibility to relapse
To assess the salivary cortisol levels (ng/ml), saliva samples are collected 5 times during the Experiment 1. (total 15 samples per participant). The saliva is collected by placing a synthetic swab between the tongue and the cheek of the participants for minimum 2 min after which it was placed in a plastic tube and stored in -20 °C until the analysis.
Time frame: First study visit. The time points of the saliva collection were the baseline, after the first 10 minutes of the treatment, after the visual stimuli, at the end of the treatment and after the 15-minute relaxation period.
Pupillary reactivity as a predictor of susceptibility to relapse
Pupillary reactivity measurements are conducted in the Aalto Behavioral Laboratory (ABL) using an EyeLink 1000 Plus eye-tracking system during the Experiment 2. Pupil size (mm) is recorded continuously throughout the cue-reactivity task at a sampling frequency of 500 Hz. Pupil size is recorded monocularly from the participant's dominant eye, as determined prior to the session.
Time frame: Second study visit (maximum 7 seven days after ensrollment). Recorded during a cue reactivity task test for approximately 5 minutes.
Event related potentials (ERP's) of electroencephalography (EEG) as a biomarker for predicting a vulnerability to relapses
ERPs (microVolts) of EEG will be recorded using an BrainAmp amplifier and an ActiCap 32-channel electrode set during the cue reactivity task test (Experiment 2.) Focus will be on P3 amplitudes. Patients with AUD, as well as other substance use disorders, have larger P3 amplitudes elicited by substance-related than neutral stimuli which indicates that P3 amplitudes reflect the neural correlates of substance craving . In addition, the AUD patients with reduced P3 amplitudes to alcohol cues are less likely to relapse than those with larger P3 amplitudes.
Time frame: Second study visit (maximum 7 seven days after ensrollment. EEG will be recorded though out the cue reactivity task test for approximately 5 minute.
Number of patients experiensing adverse reactions (Safety and Tolerability)
Number of patients experiensing adverse reactions during the experimets and follow-up and numer of reported reactions
Time frame: 3 weeks from the enrollment (First and second study visits and a two-week follow-up)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The data cannot be shared due to the GDPR regulations.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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