Oxytocin for drug relapse preventio

Phase 1

Conditions: substance use disorder
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: CTIS2023-504518-31-00

Lead Sponsor: Fondazione Santa Lucia IRCCS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

1) Primary diagnosis of substance use disorder according to DSMV criteria 2) Males and non-lactating, non-pregnant females, aged 18-55 years. 3) Patients must be willing and able to give informed consent 4) Patients must have understanding of Italian 5) Patients must provide an identity document

Exclusion Criteria

1) Major psychiatric disorders, such as Schizophrenia, Severe psychosis, Bipolar Affective Disorder, severe Depression with suicidal ideation and intention, Antisocial Personality Disorder and currently symptomatic Anxiety Disorders 2) Pregnant females and those planning a pregnancy; lactating mothers 3) Clinically significant medical condition such as cardiovascular disease (heart disease, heart attacks, abnormally high blood pressure), kidney disease, thyroid disease, epilepsy and brain trauma, that might interfere with the evaluation of the study medication or present a safety concern 4) Nasal cavity pathology (e.g. atrophic rhinitis, previous hypophysectomy, recurrent bleeding, perforation of the nasal septum) 5) Current alcohol use disorder if under pharmacological treatment 7) Any other condition that in the judgement of the investigator would preclude participation

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate the efficacy of Syntocinon in reducing craving for the drug (e.g. heroin, cocaine) in drug dependent individuals and in preventing relapse to drug use;Secondary Objective: Determine which neural substrate activation pattern underlies drug cue-incubation of craving and whether the identified regions are sensitive to pharmacological treatment with Syntocinon in SUD patients;Primary end point(s): - 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 Outcome Measures

Name	Time	Method
Secondary end point(s):- 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.