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Not yet recruitingNCT07585656Updated May 14, 2026

Comparison of the Italian and U.S. Forensic Models for Dual-diagnosis Offenders: a 3-year Longitudinal Study

An observational study in SCHIZOPHRENIA 1 (Disorder) and Substance Abuse, sponsored by University of Bari. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by University of Bari · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
600
Ages
18 Years to 75 Years
Sex
All
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Study summary

This study aims to compare the Italian and U.S. forensic models in the treatment of offenders with dual diagnosis through a three-year longitudinal design. In Italy, the closure of Judicial Psychiatric Hospitals following Law 81/2014 led to the establishment of a community-based forensic system centered on REMS (Residences for the Execution of Security Measures), integrated within the National Health Service. This model seeks to limit institutionalization and promote rehabilitative pathways in community settings. However, it continues to face challenges related to limited bed availability, waiting lists, and the complex management of social dangerousness. In contrast, the U.S. system, particularly in California, is characterized by high-security forensic psychiatric hospitals with large capacities, but also presents issues such as prolonged hospitalizations, an aging patient population, and a high prevalence of substance use disorders.

Dual diagnosis, defined as the co-occurrence of psychiatric disorders and substance use disorders, is highly prevalent in forensic populations and is associated with increased clinical complexity, higher risk of recidivism, and poorer treatment outcomes. Neurobiological and psychological mechanisms underlying addiction-including dysfunctions in the dopaminergic reward system, craving processes, and impairments in executive functioning-contribute to reduced behavioral control and increased impulsivity. Theoretical models such as the self-medication hypothesis and multifactorial frameworks suggest that substance use may both exacerbate psychiatric symptoms and represent an attempt to regulate them.

Given these complexities, integrated treatment approaches that combine psychiatric care and addiction interventions are essential, particularly in forensic settings. The present study includes offenders with mental illness in forensic care systems in Italy and California, encompassing both custodial and non-custodial settings. Participants will be followed over a three-year period, with assessments conducted at 12, 24, and 36 months. The methodology involves the use of standardized instruments to evaluate psychopathological severity, global functioning, risk of violent recidivism, protective factors, treatment adherence, impulsivity, and substance use. Data on clinical outcomes, antisocial behaviors, and discharge conditions will also be collected.

The primary objectives of the study are to describe and compare the clinical, demographic, and criminological profiles of forensic populations with dual diagnosis; to examine treatment pathways and outcomes; to identify indicators of treatment effectiveness; and to evaluate both risk and protective prognostic factors, as well as their predictive value for recidivism and clinical trajectories.

The expected impact of the study lies in improving the understanding of differences between community-based and hospital-based forensic models, with the goal of identifying integrated strategies capable of enhancing rehabilitation, reducing recidivism, and improving long-term outcomes. Findings may contribute to the development of more effective and individualized treatment approaches, as well as inform health and judicial policies aimed at better integrating clinical care and risk management in dual diagnosis forensic populations.

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Conditions studied

  • SCHIZOPHRENIA 1 (Disorder)
  • Substance Abuse

Keywords

  • forensic treatment
  • SUD
  • forensic psychiatry
03

In context

Substance-Related Disorders

2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.

This study's planned enrollment of 600 is above the median of 251 across 299 observational studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

University of Bari is the lead sponsor of 76 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population consists of adult offenders with mental disorders recruited from forensic psychiatric care systems in Italy and California. Participants are enrolled at the time of the application of a security measure or upon admission to a forensic facility, including both custodial and non-custodial settings.

In the Italian cohort, participants include individuals placed under security measures within the National Health Service, such as those admitted to REMS or managed in community-based forensic or psychiatric services. This group reflects the community-oriented Italian forensic model, characterized by rehabilitative pathways and integration with territorial mental health services.

In the California cohort, participants are recruited from high-security forensic hospitals and community forensic programs under the Department of State Hospitals, including individuals deemed incompetent to stand trial (IST) or not guilty by reason of insanity (NGRI). This population reflects a h

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 years or older.
  • Individuals admitted to forensic psychiatric care in Italy or California.
  • Presence of a diagnosed mental disorder according to / ICD criteria.
  • Presence of a current or lifetime Substance Use Disorder, consistent with a dual-diagnosis condition.
  • Placement in one of the study settings:

Italy: REMS or other forensic/community facilities under custodial or non-custodial security measures; California: Department of State Hospitals forensic facilities.

  • Ability to provide written , or consent provided through a legal guardian when applicable.
  • Availability for longitudinal follow-up at 12, 24, and 36 months.

Exclusion criteria

Exclusion Criteria:

  • Absence of a confirmed psychiatric disorder.
  • Absence of current or lifetime Substance Use Disorder.
  • Non-forensic psychiatric patients without criminal justice involvement.
  • Severe cognitive impairment or neurological condition preventing valid assessment.
  • Acute medical or psychiatric instability that makes participation temporarily impossible.
  • Inability to complete the assessment procedures, even with support or adapted administration.
  • Refusal to participate or withdrawal of . Insufficient clinical, forensic, or follow-up data for longitudinal analysis.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
600 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Violent Recidivism Risk

    The risk of violent recidivism will be assessed longitudinally using structured professional judgment approaches, integrating dynamic clinical, historical, and risk management factors. Changes over time will be analyzed to evaluate the impact of treatment and system-related variables on future violence risk.

    Time frame: from enrollment at 3 years

  2. Clinical Improvement (Psychopathology)

    Clinical severity will be measured through standardized psychiatric rating scales, capturing changes in psychopathological symptoms across the follow-up period. This outcome reflects the effectiveness of treatment in reducing symptom burden and improving mental stability.

    Time frame: from enrollment to 3 years

  3. Substance Use Severity and Relapse

    Substance use severity and relapse will be evaluated using validated screening tools and clinical data, focusing on patterns of use, reduction, and recurrence over time. This outcome is central to understanding the trajectory of dual diagnosis and its interaction with clinical and forensic outcomes.

    Time frame: from enrollment to 3 years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Jun 2027, 12 months later.

Of 122 non-industry observational studies under Substance-Related Disorders, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 56. This study's planned 12 months is below that.

Counting every sponsor, half of 133 studies reached it within 36 months; a quarter within 18 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2026
First posted
May 14, 2026
StartEst.
Jun 1, 2026
Primary completionEst.
Jun 1, 2027
CompletionEst.
Jun 1, 2029
Last update
May 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07585656
Lead sponsor
University of Bari
Responsible party
Felice Carabellese (Full Professor of Forensic Psychiatry, University of Bari) — Principal investigator
First posted
May 14, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 1, 2029 (estimated)
Last update
May 14, 2026

Study contacts

Felice F. Carabellese, Medical doctor, Full Professor
Contact
felicefrancesco.carabellese@uniba.it
+39330673152
Bernardo Bozza, Medical Doctor, psychiatrist
Contact
bernardo.bozza@uniroma1.it
+393406740680
Felice F. Carabellese, Medical doctor, Full Professor
principal investigator · University of Bari Aldo Moro

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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