substance use disorder
Conditions
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
DRUGoplossing
DRUGIalu Clenny nasal spray (hyaluronic acid and isotonic saline solution)
DRUGCE-marked medical device.
Used as placebo comparator in this clinical trial.
The product does not contain the active investigational medicinal product (oxytocin).
Although commercially marketed as a medical device
DRUGwhen used as placebo within this clinical trial it is handled in accordance with Annex 13 GMP requirements for IMPs
DRUGincluding appropriate labelling and QP certification.
Sponsors
Fondazione Santa Lucia IRCCS
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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. | — |
Outcome results
None listed