Evidence map›Paper›PMID 38178233›Full record

ArticleTrials2024

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, Joël Billieux, Anja Dirkzwager, Katia Iglesias, Karine Moschetti, Nader Perroud, Marie Schneider, Nathalie Vernaz, Hans Wolff, Patrick Heller

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05842330 (Benefits of In-prison OROS-methylphenidate vs. Placebo Treatment in Detained People With Attention-deficit/Hyperactivity Disorder), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05842330 phase3recruitingnot on this map

Benefits of In-prison OROS-methylphenidate vs. Placebo Treatment in Detained People With Attention-deficit/Hyperactivity Disorder: A Randomized Controlled Trial

TypeinterventionalSponsorStéphanie BaggioRan2024 to 2027Enrolled150ConditionsADHDArmsConcerta, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 5 countries.

Stéphanie BaggioInstitute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland. stephanie.baggio@unibe.ch.ORCID http://orcid.org/0000-0002-5347-5937
Joël BillieuxInstitute of Psychology, University of Lausanne, Lausanne, Switzerland.
Anja DirkzwagerNetherlands Institute for the Study of Crime and Law Enforcement, Amsterdam, The Netherlands.
Katia IglesiasSchool of Health Sciences, HES-SO University of Applied Sciences and Arts of Western Switzerland, Fribourg, Switzerland.
Karine MoschettiHealth Technology Assessment Unit, University Hospital of Lausanne, Lausanne, Switzerland.
Nader PerroudDepartment of Psychiatry, Faculty of Medicine, University of Geneva, Geneva, Switzerland.
Marie SchneiderInstitute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, University of Lausanne, Geneva, Switzerland.
Nathalie VernazDivision of Clinical Pharmacology and Toxicology, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
Hans WolffDivision of Prison Health, Geneva University Hospitals, Geneva, Switzerland.
Patrick HellerDivision of Prison Health, Geneva University Hospitals, Geneva, Switzerland.
University Hospital of Geneva · CHUniversity of Geneva · CHAddiction Switzerland · CHHES-SO University of Applied Sciences and Arts Western Switzerland · CHNetherlands Institute for the Study of Crime and Law Enforcement · NLUniversity Hospital of Lausanne · CHUniversity of Bern · CH

Funding

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung 212581
6 · The paper itself

Abstract

backgroundAttention-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.

methodsThis 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 registrationClinicalTrials.gov NCT05842330 . Registered on June 5, 2023. Kofam.ch SNCTP000005388. Registered on July 17, 2023.

Indexed as

Attention Deficit Disorder with HyperactivityCentral Nervous System StimulantsMethylphenidateClinical Trials, Phase III as TopicDelayed-Action PreparationsDouble-Blind MethodEquivalence Trials as TopicHumansMalePrisonsRandomized Controlled Trials as TopicTreatment OutcomeCentral Nervous System StimulantsDelayed-Action PreparationsMethylphenidateAccess to health careAttention-deficit/hyperactivity disorderPrisonRecidivism

Identifiers

PMID38178233
PMCPMC10765778
OpenAlexW4390582235

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.