. 2024 Jan 4;25(1):23.

doi: 10.1186/s13063-023-07827-7.

Protocol of a monocentric, double-blind, randomized, superiority, controlled trial evaluating the effect of in-prison OROS-methylphenidate vs. placebo treatment in detained people with attention-deficit hyperactivity disorder (BATIR)

Stéphanie Baggio^{1

2

3}, Joël Billieux^{4

5}, Anja Dirkzwager⁶, Katia Iglesias⁷, Karine Moschetti^{8

9}, Nader Perroud^{10

11

12}, Marie Schneider^{13

14}, Nathalie Vernaz¹⁵, Hans Wolff¹⁶, Patrick Heller^{16

9}

Affiliations

¹ Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland. stephanie.baggio@unibe.ch.
² Laboratory of Population Health (#PopHealthLab), University of Fribourg, Fribourg, Switzerland. stephanie.baggio@unibe.ch.
³ Division of Prison Health, Geneva University Hospitals, Geneva, Switzerland. stephanie.baggio@unibe.ch.
⁴ Institute of Psychology, University of Lausanne, Lausanne, Switzerland.
⁵ Center for Excessive Gambling, Addiction Medicine, Lausanne University Hospitals (CHUV), Lausanne, Switzerland.
⁶ Netherlands Institute for the Study of Crime and Law Enforcement, Amsterdam, The Netherlands.
⁷ School of Health Sciences, HES-SO University of Applied Sciences and Arts of Western Switzerland, Fribourg, Switzerland.
⁸ Health Technology Assessment Unit, University Hospital of Lausanne, Lausanne, Switzerland.
⁹ Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.
¹⁰ Department of Psychiatry, Faculty of Medicine, University of Geneva, Geneva, Switzerland.
¹¹ Division of Psychiatric Specialties, Department of Psychiatry, University Hospitals of Geneva, Geneva, Switzerland.
¹² Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada.
¹³ Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, University of Lausanne, Geneva, Switzerland.
¹⁴ Medication adherence and Interprofessionality lab, School of Pharmaceutical Sciences, University of Geneva, Geneva, Switzerland.
¹⁵ Division of Clinical Pharmacology and Toxicology, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
¹⁶ Division of Prison Health, Geneva University Hospitals, Geneva, Switzerland.

PMID: 38178233
PMCID: PMC10765778
DOI: 10.1186/s13063-023-07827-7

Protocol of a monocentric, double-blind, randomized, superiority, controlled trial evaluating the effect of in-prison OROS-methylphenidate vs. placebo treatment in detained people with attention-deficit hyperactivity disorder (BATIR)

Stéphanie Baggio et al. Trials. 2024.

. 2024 Jan 4;25(1):23.

doi: 10.1186/s13063-023-07827-7.

Authors

Affiliations

¹ Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland. stephanie.baggio@unibe.ch.
² Laboratory of Population Health (#PopHealthLab), University of Fribourg, Fribourg, Switzerland. stephanie.baggio@unibe.ch.
³ Division of Prison Health, Geneva University Hospitals, Geneva, Switzerland. stephanie.baggio@unibe.ch.
⁴ Institute of Psychology, University of Lausanne, Lausanne, Switzerland.
⁵ Center for Excessive Gambling, Addiction Medicine, Lausanne University Hospitals (CHUV), Lausanne, Switzerland.
⁶ Netherlands Institute for the Study of Crime and Law Enforcement, Amsterdam, The Netherlands.
⁷ School of Health Sciences, HES-SO University of Applied Sciences and Arts of Western Switzerland, Fribourg, Switzerland.
⁸ Health Technology Assessment Unit, University Hospital of Lausanne, Lausanne, Switzerland.
⁹ Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland.
¹⁰ Department of Psychiatry, Faculty of Medicine, University of Geneva, Geneva, Switzerland.
¹¹ Division of Psychiatric Specialties, Department of Psychiatry, University Hospitals of Geneva, Geneva, Switzerland.
¹² Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada.
¹³ Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, University of Lausanne, Geneva, Switzerland.
¹⁴ Medication adherence and Interprofessionality lab, School of Pharmaceutical Sciences, University of Geneva, Geneva, Switzerland.
¹⁵ Division of Clinical Pharmacology and Toxicology, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
¹⁶ Division of Prison Health, Geneva University Hospitals, Geneva, Switzerland.

PMID: 38178233
PMCID: PMC10765778
DOI: 10.1186/s13063-023-07827-7

Abstract

Background: Attention-deficit hyperactivity disorder (ADHD) is characterized by difficulty paying attention, poor impulse control, and hyperactive behavior. It is associated with several adverse health and social outcomes and leads to an increased risk of criminality and recidivism. Worldwide, ADHD is thus highly prevalent in prisons. However, ADHD treatment has been neglected in such environments. Stimulant medications such as osmotic-release oral system methylphenidate (OROS-MPH) are first-line treatments in the general population, but they are under-prescribed in prisons due to concerns about abuse, even though such claims are not empirically supported. This project aims to compare the efficacy of a 3-month in-prison OROS-MPH vs. placebo treatment on the severity of core ADHD symptoms and relevant in- and post-prison outcomes.

Methods: This study is a phase III, double-blinded, randomized, superiority, controlled trial of OROS-MPH vs. placebo. After randomization, the participants will receive 3 months of treatment with OROS-MPH or placebo (1:1 ratio) while incarcerated. Upon release, all participants will be offered the treatment (OROS-MPH) for 1 year but will remain blinded to their initial study group. The study will be conducted at the Division of Prison Health, Geneva, Switzerland, among incarcerated men (n = 150). Measures will include (1) investigator-rated ADHD symptoms, (2) acute events collected by the medical and prison teams, (3) assessment of the risk of recidivism, (4) medication side effects, (5) medication adherence, (6) study retention, (7) health care/prison costs, and (8) 1-year recidivism. Analyses will include bivariable and multivariable modeling (e.g., regression models, mixed-effects models, survival analyses) and an economic evaluation (cost-benefit analysis).

Discussion: We expect that early identification and treatment of ADHD in prison will be an important public health opportunity and a cost-effective approach that is likely to reduce the vulnerability of incarcerated individuals and promote pathways out of criminal involvement. The study will also promote standards of care for people with ADHD in prison and provide recommendations for continuity of care after release.

Trial registration: ClinicalTrials.gov NCT05842330 . Registered on June 5, 2023. Kofam.ch SNCTP000005388. Registered on July 17, 2023.

Keywords: Access to health care; Attention-deficit/hyperactivity disorder; Prison; Recidivism.

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Conflict of interest statement

The authors declare that they have no competing interests.

References

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Protocol of a monocentric, double-blind, randomized, superiority, controlled trial evaluating the effect of in-prison OROS-methylphenidate vs. placebo treatment in detained people with attention-deficit hyperactivity disorder (BATIR)

Affiliations

Protocol of a monocentric, double-blind, randomized, superiority, controlled trial evaluating the effect of in-prison OROS-methylphenidate vs. placebo treatment in detained people with attention-deficit hyperactivity disorder (BATIR)

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical