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Clinical trial of sustained release methylphenidate for Attention Deficit Hyperactivity Disorder (ADHD) in adult criminal offenders with amphetamine addiction

Clinical trial of sustained release methylphenidate for Attention Deficit Hyperactivity Disorder (ADHD) in adult criminal offenders with amphetamine addiction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN77940178
Enrollment
54
Registered
2007-10-26
Start date
2007-04-12
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder (ADHD) Mental and Behavioural Disorders Disturbance of activity and attention

Interventions

Inmates who volunteer for the study are screened with the adult ADHD Self-Report Scale (ASRS) and Wender Utah Rating Scale (WURS) and the Structured Clinical Interview for DSM-IV (SCID-I) by a psychol
they also leave a urine specimen and a blood sample to test liver function and hepatitis. 14 days before their release they are included in the study given that they meet all the parameters required.

Sponsors

Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Male prison inmates 2. 18 to 65 years of age 3. Those who meet the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for amphetamine addiction and for ADHD 4. Those who, after release from prison, have an address and phone number in Stockholm area where they can be reached

Exclusion criteria

Exclusion criteria: 1. Opioid, alcohol, cannabis or benzodiazepine addiction 2. Other serious psychiatric conditions apart from substance abuse/addiction (i.e. dementia, severe depression with suicidal ideation, acute psychotic symptoms, chronic schizophrenic syndrome) 3. Ongoing medication with benzodiazepines or neuroleptics 4. Acute symptoms of withdrawal regardless of substance 5. Known heart condition 6. History of stroke 7. Other severe medical condition (cancer, hypertension, glaucoma, advanced arteriosclerosis, liver cirrhosis or any medical condition that could mean a risk for the patient) 8. Known hypersensitivity to methylphenidate

Design outcomes

Primary

MeasureTime frame
Percentage of urine samples with no trace of drugs of abuse (amphetamines, opioids, benzodiazepines, delta-9-Tetrahydrocannabinol (THC), cocaine, dextropropoxifen, buprenorphine), analysed at week 12 and 24.

Secondary

MeasureTime frame
The following will be analysed at week 12 and 24: 1. Relapse to crime (readmission to prison or other legal action for criminal offence, self-reported criminality) 2. Self-reported reduction in ADHD-symptoms, assessed using the Conners' Adult ADHD Rating Scales (CAARS) 3. Reduction in psychiatric symptoms, assessed using Outcome Questionaire 45 4. Plasma concentration of methylphenidate 5. Clinician reported reduction in ADHD-symptoms (Clinical Global Impressions [CGI] scale) 6. Self-reported drug-craving measured on a Visual Analogue Scale (VAS) 7. Reduction of problems in attention assessed by Connors' Continuous Performance Test (CPT) 8. Self-reported drug use, assessed using the Addiction Severity Index (ASI) and time-line follow-back 9. Interpersonal Problems (IIP)

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026