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Leveraging the neural mechanisms of social reward for drug relapse prevention

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504518-31-00
Enrollment
70
Registered
2023-07-12
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

substance use disorder

Brief summary

- Cue-incubation of craving - BOLD fMRI activation signal in the amygdala, insula, ventral striatum and anterior cingulate cortex Timepoint(s) of evaluation of this endpoint Self-report measure of craving following cue exposures at day 7 and day 30 (one week and four weeks into the placebo/Syntocinon treatment period) compared to day 1. BOLD fMRI signal will be evaluated on day 30 compared to day 1.

Detailed description

- Measures of social/emotional cognition evaluated via Picture viewing task, Go/no-go task, Cyberball task and Social Gaze task - Duration of abstinence Timepoint(s) of evaluation of this endpoint Scores will be registered at day 7 and day 30 (one week and four weeks into the placebo/Syntocinon treatment period) compared to day 1. To assess duration of abstinence, drug use will be evaluated at follow ups at 3- and 6-months following termination of treatment period.

Interventions

DRUGSODIUM CHLORIDE

Sponsors

Fondazione Santa Lucia IRCCS
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
- Cue-incubation of craving - BOLD fMRI activation signal in the amygdala, insula, ventral striatum and anterior cingulate cortex Timepoint(s) of evaluation of this endpoint Self-report measure of craving following cue exposures at day 7 and day 30 (one week and four weeks into the placebo/Syntocinon treatment period) compared to day 1. BOLD fMRI signal will be evaluated on day 30 compared to day 1.

Secondary

MeasureTime frame
- Measures of social/emotional cognition evaluated via Picture viewing task, Go/no-go task, Cyberball task and Social Gaze task - Duration of abstinence Timepoint(s) of evaluation of this endpoint Scores will be registered at day 7 and day 30 (one week and four weeks into the placebo/Syntocinon treatment period) compared to day 1. To assess duration of abstinence, drug use will be evaluated at follow ups at 3- and 6-months following termination of treatment period.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026