Alcohol Use DisorderNCT07920601
Effects of C-Tactile-optimal Touch on Alcohol Craving and Relapse-Related Biomarkers in Alcohol Use Disorder
A study testing CT- optimal Robotic skin stimulation and Non-CT-optimal Robotic skin stimulation in people with Alcohol Use Disorder, run by Aalto University at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- CT- optimal Robotic skin stimulation and Non-CT-optimal Robotic skin stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteFinland
- Study dates
- 19 Jan 2023to 14 Oct 2023
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subject has blood alcohol cotent of 0.00% at the Visit 1.
- The subject has mild or moderate diagnosis of alcohol use disorder as measured by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- Males and females aged 18 to 60.
- Able to provide Timeline Follow Back alcohol consumption information for the 28-day period prior to the Visit 1.
- A subject has had ≥6 heavy drinking days in the 4 weeks prior to the online screening.
- The subject has had ≤14 consecutive abstinent days preceding the Visit 1.
Show all 9Show fewer
- Willingness to provide a saliva sample for cortisol analysis
- Able to read and understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the relapse counselling.
- The subjects must have normal or corrected-to-normal eyesight.
Who cannot join
- Patients with withdrawal symptoms at the Visit 1, monitored with Clinical Institute Withdrawal Assessment of Alcohol Scale.
- Subjects with diagnosis of any of the following concomitant psychiatric disorders: non-treated, unstable schizophrenia, bipolar disorder, other psychotic disorder during the lifetime of the subject.
- 5. Subjects with current use of any other addictive substances (excluding nicotine).
- 6. The subject has been treated with any investigational 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 clinically significant 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.
Show all 10Show fewer
- 10. Current use of systemic steroids 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.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Aalto University, Department of Neuroscience and Biomedical Engineering and Aalto NeuroImaging (ANI) Infrastructure Aalto Behavioral Laboratory
Espoo
About this study
Official title: A Pilot Study to Assess the Effects of Mechanic Activation of C-tactile Afferent Nerves on Relapse Predicting Biomarkers and Alcohol Craving in AUD Patients During Early Abstinence, a 4-week Study
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.
Read more
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- CT- optimal Robotic skin stimulation, Non-CT-optimal Robotic skin stimulation
- Keywords
- Alcohol use disorder, touch, C-tactile afferent, Robotic touch, pupillary reactivity, heart rate vaiability
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT- optimal Robotic skin stimulationDevice
Also called 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.
Non-CT-optimal Robotic skin stimulationDevice
Also called Non-CT-optimal touch
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.
| Study group | Role | What they receive |
|---|---|---|
| CT-optimal touch | Experimental | The active treatment is CT-optimal slow (3 cm/s) stroking tactile stimulation produced with a mechanically moving cosmetic brush Receives: Device: CT- optimal Robotic skin stimulation |
| non-CT-optimal touch | Placebo comparator | 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. Receives: Device: Non-CT-optimal Robotic skin stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Second study visit (maximum 7 seven days after ensrollment. EEG will be recorded though out the cue reactivity task test for approximately 5 minute.
Secondary outcomes (1)
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
Measured: 3 weeks from the enrollment (First and second study visits and a two-week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start19 Jan 2023
- Primary completion29 Sep 2023
- Study completion14 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, randomized, single-blind, placebo (non-CT-activating touch) controlled parallel group trial to explore the feasibility, tolerability, and efficacy of mechanic CT-optimal touch to reduce alcohol craving and relapse susceptibility in adult subjects with diagnosed AUD.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalto University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hannu Alho, Professor Emeritus, PhD, MD, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920601
- Sponsor's protocol ID
- AY-NBE-HT-101
- Status last verified
- Nov 2026
- First submitted
- 8 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data cannot be shared due to the GDPR regulations.
Publications
Harkki J, Tuovinen P, Jousmaki V, Barreto G, Rapeli P, Palomaki J, Annevirta J, Puisto AH, McGlone F, Nieminen H, Alho H. CT-optimal touch modulates alcohol-cue-elicited heart rate variability in alcohol use disorder patients during early abstinence: A randomized controlled study. Alcohol. 2025 Mar;123:19-26. doi: 10.1016/j.alcohol.2024.11.004. Epub 2024 Nov 27.
PubMed 39608682
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Effects of Mechanic Activation of C-tactile Afferent Nerves on Relapse Predicting Biomarkers and Alcohol Craving in AUD Patients During Early Abstinence, a 4-week Study
- ClinicalTrials.gov ID
- NCT07920601
- Acronym / sponsor ID
- AY-NBE-HT-101
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol use disorder, touch, C-tactile afferent, Robotic touch, pupillary reactivity, heart rate vaiability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Aalto UniversityUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 14 Oct 2023 (actual)
- First posted
- 5 Nov 2026 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A single-center, randomized, single-blind, placebo (non-CT-activating touch) controlled parallel group trial to explore the feasibility, tolerability, and efficacy of mechanic CT-optimal touch to reduce alcohol craving and relapse susceptibility in adult subjects with diagnosed AUD.
| Arm | Type | Receives |
|---|---|---|
| CT-optimal touch | Experimental | Device: CT- optimal Robotic skin stimulationThe active treatment is CT-optimal slow (3 cm/s) stroking tactile stimulation produced with a mechanically moving cosmetic brush |
| non-CT-optimal touch | Placebo comparator | Device: Non-CT-optimal Robotic skin stimulationThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- The subject has blood alcohol cotent of 0.00% at the Visit 1.
- The subject has mild or moderate diagnosis of alcohol use disorder as measured by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- Males and females aged 18 to 60.
- Able to provide Timeline Follow Back alcohol consumption information for the 28-day period prior to the Visit 1.
- A subject has had ≥6 heavy drinking days in the 4 weeks prior to the online screening.
Key exclusion criteria (10 listed)
- Patients with withdrawal symptoms at the Visit 1, monitored with Clinical Institute Withdrawal Assessment of Alcohol Scale.
- Subjects with diagnosis of any of the following concomitant psychiatric disorders: non-treated, unstable schizophrenia, bipolar disorder, other psychotic disorder during the lifetime of the subject.
- 5. Subjects with current use of any other addictive substances (excluding nicotine).
- 6. The subject has been treated with any investigational 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.
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 |
|---|---|---|
| CT- optimal Robotic skin stimulationAlso: Robotic CT-optimal touch, CT-optimal skin stimulation, CT-optimal stimulation, CT-optimal tactile stimulatinTo 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. | Device | CT-optimal touch |
| Non-CT-optimal Robotic skin stimulationAlso: Non-CT-optimal touchTo 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. | Device | non-CT-optimal touch |
Primary outcome
Heart rate variability (HRV) reactivity as a biomarker of stress and a predictor of susceptibility to relapse
Time frame: Measurement taken during each participant's first study visit for approximately 32 minutes.
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.
Self-reported Alcohol craving
Time frame: The first and second study visits. Maximum 7 days in between the visits.
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.
Salivary cortisol as a biomarker of stress and a predictor of susceptibility to relapse
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.
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.
Pupillary reactivity as a predictor of susceptibility to relapse
Time frame: Second study visit (maximum 7 seven days after ensrollment). Recorded during a cue reactivity task test for approximately 5 minutes.
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.
Event related potentials (ERP's) of electroencephalography (EEG) as a biomarker for predicting a vulnerability to relapses
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.
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.
1 secondary outcome
Number of patients experiensing adverse reactions (Safety and Tolerability)
Time frame: 3 weeks from the enrollment (First and second study visits and a two-week follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Results publication: PubMed 39608682Harkki J, Tuovinen P, Jousmaki V, Barreto G, Rapeli P, Palomaki J, Annevirta J, Puisto AH, McGlone F, Nieminen H, Alho H. CT-optimal touch modulates alcohol-cue-elicited heart rate variability in alcohol use disorder patients during early abstinence: A randomized controlled study. Alcohol. 2025 Mar;123:19-26. doi: 10.1016/j.alcohol.2024.11.004. Epub 2024 Nov 27.
- Individual participant dataSharing planned: No. The data cannot be shared due to the GDPR regulations.
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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.
Hannu Alho, Professor Emeritus, PhD, MD principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT- optimal Robotic skin stimulation and Non-CT-optimal Robotic skin stimulation in people with Alcohol Use Disorder, run by Aalto University at 1 site in Finland.
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 9 inclusion and 10 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: finished, as of the sponsor's last update on 5 Nov 2026. 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 Finland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heart rate variability (HRV) reactivity as a biomarker of stress and a predictor of susceptibility to relapse (time frame: Measurement taken during each participant's first study visit for approximately 32 minutes.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07920601, which also lists 1 linked publication.
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 5 Nov 2026.