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Substance Use Disorder (SUD)NCT06806943

How Avatar Can Enhance Autobiographical Memory of Patients With Substance Use Disorder

A study testing avatar-based interactions in people with Substance Use Disorder (SUD), run by Le.L.A.T. Lega Lotta Aids E Tossicodipendenza at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to investigate whether the use of artificial intelligence platforms can promote the retrieval of specific positive autobiographical memories. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Substance Use Disorder (SUD)
What is being tested?
avatar-based interactions
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteItaly
Study dates
1 Jul 2024to 15 Dec 2024
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of substance use disorder
  • Admitted to the drug rehabilitation center for at least 3 months
  • Aged 18 years or older

Who cannot join

  • Previous neurological pathologies
  • Previous cognitive deficits

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Le.L.A.T. Lega Lotta Aids E Tossicodipendenza

    Messina, 98124

Other trials in Italy

About this study

The goal of this study is to investigate whether the use of artificial intelligence platforms can promote the retrieval of specific positive autobiographical memories.

Read the detailed description

The decision to focus on the retrieval of positive autobiographical memories was made for ethical reasons and is not tied to any specific research hypothesis. Specifically, the study aims to assess whether artificial intelligence facilitates the sharing of personal experiences and reflection on autobiographical memories related to substance use disorders, taking into account the potential influence of individual characteristics such as recent mood state, and overall memory functioning.

Being tested
avatar-based interactions
Keywords
autobiographical memory, substance use disorder
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • avatar-based interactionsDevice

    SUD patients were investigated using the Autobiographical Memory Test in two conditions: face-to-face and avatar-based interactions. Patients had to recall 6 neutral cue words and 6 substance-related cue words for each condition.

Study groups in NCT06806943
Study groupRoleWhat they receive
Avatar / Face-to-faceExperimentalSUD patients were investigated using the Autobiographical Memory Test in two conditions: face-to-face and avatar-based interactions. Patients had to recall 6 neutral cue words and 6 substance-related cue words for each condition.
Receives: Device: avatar-based interactions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Specific Autobiographical Memory Recall

    The primary outcome measure is the difference in the number of specific autobiographical memories recalled between the avatar-based interaction condition and the face-to-face condition, as assessed by the Autobiographical Memory Test (AMT). Specificity of recalled memories are scored using standardized criteria. This measure evaluates the effectiveness of avatar-based interventions in changing AM recall in patients with substance use disorder (SUD).

    Measured: During the intervention sessions for both conditions (avatar-based and face-to-face). This outcome directly reflects the study's objective by quantifying the change of AM recall through avatar-based interventions.

Secondary outcomes (3)

  1. Latency of Autobiographical Memory Recall

    The secondary outcome measure is the comparison of latency times (time taken to recall a memory) between the avatar-based interaction condition and the face-to-face condition, as recorded during the Autobiographical Memory Test (AMT). This measure evaluates whether the use of avatar-based interventions change the speed of autobiographical memory recall in patients with substance use disorder (SUD).

    Measured: During the intervention sessions for both conditions (avatar-based and face-to-face).

  2. Pleasantness of Autobiographical Memories Recalled

    The secondary outcome measure is the comparison of pleasantness ratings of autobiographical memories recalled between the avatar-based interaction condition and the face-to-face condition. Pleasantness is assessed during the Autobiographical Memory Test (AMT). This measure evaluates whether avatar-based interventions change the emotional valence of the memories retrieved by patients with substance use disorder (SUD).

    Measured: During the intervention sessions for both conditions (avatar-based and face-to-face).

  3. Change in Age Memory Recall

    The secondary outcome measure is the change in age memory recall, defined as the participants' ability to identify the age at which autobiographical memories occurred, comparing the avatar-based interaction condition to the face-to-face condition. Age memory is assessed during the Autobiographical Memory Test (AMT) for each recalled memory. This measure evaluates whether avatar-based interventions change temporal specificity in autobiographical memory recall among patients with substance use disorder (SUD).

    Measured: During the intervention sessions for both conditions (avatar-based and face-to-face).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2025
  2. Study start1 Jul 2024
  3. Primary completion15 Dec 2024
  4. Study completion15 Dec 2024

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
within-subject design
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06806943
Sponsor's protocol ID
MEM-AV
Status last verified
Jan 2025
First submitted
27 Jan 2025
Last updated
4 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We plan to share the Individual Participant Data (IPD) starting from January 25, 2025. The data will be made available for research purposes to qualified researchers who submit a formal request and have an approved data-sharing agreement. Access will be contingent upon ensuring that proper data protection and confidentiality measures are followed, in compliance with ethical guidelines and applicable data protection laws. The data will not be shared for commercial purposes without further approval. The IPD will be made available for 5 years from the date of release.

Publications

  • Nandrino JL, Gandolphe MC, El Haj M. Autobiographical memory compromise in individuals with alcohol use disorders: Towards implications for psychotherapy research. Drug Alcohol Depend. 2017 Oct 1;179:61-70. doi: 10.1016/j.drugalcdep.2017.06.027. Epub 2017 Jul 21.

    PubMed 28756101

  • Nandrino JL, Gandolphe MC. Characterization of Self-Defining Memories in Individuals with Severe Alcohol Use Disorders After Mid-Term Abstinence: The Impact of the Emotional Valence of Memories. Alcohol Clin Exp Res. 2017 Aug;41(8):1484-1491. doi: 10.1111/acer.13424. Epub 2017 Jun 14.

    PubMed 28556207

  • De Groote C, Cottencin O, Tison P, Triquet C, Nandrino JL. Autobiographical memories cued by self-statements in patients with alcohol use disorder: linking self-conceptions to past events. Memory. 2023 May;31(5):732-746. doi: 10.1080/09658211.2023.2191899. Epub 2023 Mar 22.

    PubMed 36950753

  • Nandrino JL, El Haj M, Torre J, Naye D, Douchet H, Danel T, Cottencin O. Autobiographical Memory Deficits in Alcohol-Dependent Patients with Short- and Long-Term Abstinence. Alcohol Clin Exp Res. 2016 Apr;40(4):865-73. doi: 10.1111/acer.13001. Epub 2016 Mar 17.

    PubMed 26990362

  • Fernandez-Alvarez J, Colombo D, Suso-Ribera C, Chirico A, Serino S, Di Lernia D, Palacios AG, Riva G, Botella C. Using virtual reality to target positive autobiographical memory in individuals with moderate-to-moderately severe depressive symptoms: A single case experimental design. Internet Interv. 2021 May 27;25:100407. doi: 10.1016/j.invent.2021.100407. eCollection 2021 Sep.

    PubMed 34401366

  • Lenormand D, Mentec I, Gaston-Bellegarde A, Orriols E, Piolino P. Decoding episodic autobiographical memory in naturalistic virtual reality. Sci Rep. 2024 Oct 27;14(1):25639. doi: 10.1038/s41598-024-76944-3.

    PubMed 39463396

  • Frisone F, Brizzi G, Riva G. VR-MEM: Harnessing Virtual Reality for Autobiographical Memory Enhancement in High School Settings. Cyberpsychol Behav Soc Netw. 2024 Jan;27(1):91-93. doi: 10.1089/cyber.2023.29300.ceu. Epub 2023 Nov 16. No abstract available.

    PubMed 37972046

  • Frisone F, Calabro G, Rossi C, Riva G. MEM-AV: A VR-Based Approach to Improve Autobiographical Memory Retrieval in Addiction. Cyberpsychol Behav Soc Netw. 2024 May;27(5):353-355. doi: 10.1089/cyber.2024.42624. Epub 2024 May 8. No abstract available.

    PubMed 38717129

  • Pitel AL, Eustache F, Beaunieux H. Component processes of memory in alcoholism: pattern of compromise and neural substrates. Handb Clin Neurol. 2014;125:211-25. doi: 10.1016/B978-0-444-62619-6.00013-6.

    PubMed 25307577

  • Conway MA, Pleydell-Pearce CW. The construction of autobiographical memories in the self-memory system. Psychol Rev. 2000 Apr;107(2):261-88. doi: 10.1037/0033-295x.107.2.261.

    PubMed 10789197

Questions about this trial

What is this clinical trial studying?

A study testing avatar-based interactions in people with Substance Use Disorder (SUD), run by Le.L.A.T. Lega Lotta Aids E Tossicodipendenza at 1 site in Italy.

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 3 inclusion and 2 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 4 Feb 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 Italy. 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.

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?

Change in Specific Autobiographical Memory Recall (time frame: During the intervention sessions for both conditions (avatar-based and face-to-face). This outcome directly reflects the study's objective by quantifying the change of AM recall through avatar-based interventions.). 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 NCT06806943, which also lists 10 linked publications.

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 4 Feb 2025.

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