Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Single Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy of PR OROS Methylphenidate Followed by Open-Label Extension, in Swedish Male Prison Inmates With ADHD
Brief Summary: The purpose of this study is to evaluate the efficacy and effectiveness of methylphenidate in treatment of ADHD in Swedish adult male prison inmates diagnosed with ADHD.


Options:
A: Inclusion Criteria:

In order to participate in the study, subjects must

* Be at least 18 years of age and no older than 55 years of age.
* Weigh more than 100 pounds.
* Have a DSM-IV diagnosis of cocaine dependence.
* Be seeking treatment for cocaine dependence.
* Have a urine sample positive for qualitative cocaine toxicology at initial screening.
* Have the ability to understand, and having understood, provide written informed consent to comply with the treatment protocol.
* Have a history and brief physical examination that demonstrate no clinically significant contraindication for participating in the study, in the judgment of the admitting physician and the Principal Investigator.
* Have normal, or, if necessary, corrected visual acuity, visual fields, and normal fundoscopy findings

Exclusion Criteria:

* In order to participate in the study, subjects must not:

  * Meet DSM-IV criteria for current dependence on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana or physiological dependence on alcohol requiring medical detoxification.
  * Have neurological or psychiatric disorders such as: psychosis, bipolar illness, major depression, organic brain disease, dementia, any disorder which would require ongoing treatment or which would make study agent compliance difficult, history of suicide attempts assessed and/or current suicidal ideation/plan.
  * Have serious medical illnesses or other potentially life threatening or progressive medical illness other than addiction that may compromise subject safety or study conduct.
  * Have a history of traumatic head injury.
  * Be mandated by a court to obtain treatment for cocaine dependence.
  * Have been treated for cocaine addiction, or abstained from cocaine use for a significant period, within the 6 months preceding screening.
  * Be unable to complete the study protocol because of probable incarceration or relocation from the clinical area.
  * Have AIDS (although AIDS is an exclusion criterion, a positive antibody titer to HIV is not).
  * Have active syphilis that has not been treated or refuse treatment for syphilis
  * Have a history of neuroleptic malignant syndrome.
  * Have known or suspected hypersensitivity to vigabatrin or any other GABAergic drug.
  * Have received a drug with known potential for toxicity to a major organ system within 30 days prior to study entry (e.g., isoniazid, methotrexate).
  * Have participated in any experimental study within 4 weeks, or participated in any clinical trial utilizing vigabatrin.
  * Be pregnant or lactating.
  * Have any clinically significant abnormal laboratory value.
  * Have had electroconvulsive therapy with the 3 months preceding screening.
  * Have had any opiate-substitutes (methadone, LAAM, buprenorphine) within 2 months preceding screening.
  * Have a history of i.v. cocaine (or other psychoactive drug) use within 2 months preceding screening.
  * Have a current or past history of seizure disorder, including alcohol- or stimulant related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
  * Have a visual field defect, or factor predisposing to visual field defects, including glaucoma, severe myopia, retinal disorder, cataracts, diabetes or uncontrolled hypertension.
  * Have my illness, condition, and use of medications, in the opinion of the Principal Investigator and the admitting physician, which would preclude safe or successful completion of the study.
  * Be using vigabatrin or any medication that could interact adversely with vigabatrin administration, based on the longest time interval of A or B below:

    * A) Five half-lives of other medication or active metabolite(s), whichever is longer;
    * B) Two weeks.
  * Be lactose intolerant.
B: Due to the nature of this study, which includes both randomized arms (XR-NTX and enhanced TAU) as well as a non-randomized observational arm (methadone treatment group, MTP) there are separate Inclusion/Exclusion criteria for those randomized vs. Non-Randomized, detailed below.

Randomized Arms (XR-NTX, ETAU)

Inclusion Criteria:

1. Adults \>18yo incarcerated in NYC jails with known release dates.
2. DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).
3. Not currently in or planning to pursue agonist (methadone, buprenorphine) treatment at release.
4. Currently opioid free by history ('detoxed') and with a negative urine for all opioids.
5. General good health as determined by medical evaluation.

Exclusion Criteria:

1. Pregnancy, lactation, or planning conception.
2. Active medical illness (i.e., severe liver disease, congestive heart failure) precluding safe participation.
3. Untreated or poorly controlled psychiatric disorder precluding safe participation.
4. History of allergic reaction to naltrexone.
5. Current chronic pain condition treated with opioids.

Non-Randomized Arm (MTP) Inclusion Criteria

1. Adults \>18yo incarcerated in NYC jails with known release dates.
2. DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).
3. Currently receiving regular methadone maintenance treatment through KEEP.
4. General good health as determined by medical evaluation.

Exclusion Criteria

1. Pregnancy, lactation, or planning conception.
2. Active medical illness (i.e., severe liver disease, congestive heart failure) precluding safe participation.
3. Untreated or poorly controlled psychiatric disorder precluding safe participation.
4. In community methadone treatment program at the time of most recent arrest.
C: Specific site inclusion criteria include: (a) ability to provide youth service records, (b) service to youth under community supervision, (c) access to treatment provider(s) if treatment is not provided directly by the JJ agency, (d) participation in requisite intervention training/activities,(e) minimum average case flow of 10 youth per month, (f) minimum of 10 staff per site, and (g) a senior JJ staff member who agrees to serve as site leader/liaison during the study. Study sites are geographically dispersed and were identified by state JJ agencies (and not selected for particular substance use or related BH service needs).

Youth inclusion criteria include: all youth entering the juvenile justice system during the period within the exception of those who are already in treatment at the time that they are referred to the juvenile justice agency.

Staff inclusion criteria include: all staff actively working with the youth under community supervision in the site with exclusion only of higher level administrative or regional staff over multiple units..
D: Inclusion Criteria:

* Male, 18-65 years, imprisoned at Norrtalje Prison
* WURS-score of 36 or more and fulfilling at least 4 out of 6 criteria on ASRS Screener in an initial screening preceding the trial
* Can read and understand Swedish well enough to participate in the evaluation preceding the trial
* Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition, (DSM-IV) and confirmed by the neuropsychiatric assessment including structured diagnostic interviews and neuropsychological measurements.
* At least 14 months left to conditional release.
* Informed Consent Form to participate in the study signed by the subject.
* Subject agrees to take only the supplied study drug as treatment for ADHD during the study
* Subject is able to comply with the study visit schedule and willing and able to complete the protocol-specified assessments.
* Healthy on the basis of a physical examination and the results of blood biochemistry tests. If the results of the biochemistry tests are not within the normal reference ranges, the subject may be included if the investigator considers the deviations are not clinically relevant.

Exclusion Criteria:

* Known to be a non-responder to methylphenidate.
* Known allergy or hypersensitivity to methylphenidate.
* Any clinically unstable psychiatric condition including, but not limited to, acute mood disorder, bipolar disorder, acute OCD.
* A diagnosis of substance use disorder (abuse/dependence) according to DSM-IV criteria within 3 months prior to screening evaluation for the study.
* Known mental retardation.
* Subjects with history of epileptic seizures, glaucoma, uncontrolled hypertension, angina pectoris, cardiac arrhythmias or structural heart abnormalities.
* Use of monoamine oxidase inhibitors, fluoxetine, venlafaxine, reboxetine, duloxetine.
* Use of alpha-2-receptor agonists, neuroleptics, theophylline, coumarin anticoagulants or anticonvulsants.
* Liver or renal insufficiency. Subjects with hepatitis C without liver insufficiency don´t have to be excluded as long as liver enzymes are followed through the study.
* Subjects who are suicidal.
* Lactose intolerance.

Answer: D