Clinical trial of sustained release methylphenidate for Attention-Deficit-Hyperactivity-Disorder (ADHD) in adult criminal offenders with amphetamine addictio
- Conditions
- 54 male prison inmates (27 in each treatment condition) that meet the DSM-IV criteria for amphetamine addiction and for ADHD and who are servicing their prison sentence are recruited.
- Registration Number
- EUCTR2006-002249-35-SE
- Lead Sponsor
- Addiction Center Stockholm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 54
- male 18 to 65 yrs
- signed consent
- meets the criteria for amphetamine addiction and has used amphetamine in minimum 12 times times in the three month period prior to imprisonment
- meets the DSM-IV criteria for attention deficit hyperactivity disorder - ADHD
- drug free for two weeks prior to inclusion (documented with urine samples)
- imprisoned in a Swedish prison (trial is planned to take place in Håga, Södertälje
- address and phone nr in Stockholm area where person can be reached
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-- opioid, alcohol, cannabis or benzodiazepine addiction in the last 5 yrs prior to study
- other serious psychiatric conditions apart from substance abuse/addiction (i.e. dementia, severe depression with suicidal ideation, acute psychotic symptoms, chronic schizophrenic syndrome)
- ongoing medication with MAO-repressers, benzodiazepines or neuroleptics
- acute symptoms of withdrawal regardless substance
- known heart condition
- history of stroke
- other severe medical condition (cancer, hypertonic, glaucoma, advanced arteriosclerosis, liver cirrhosis or any medical condition that could mean a risk for the patient)
- known hypersensibility to methylphenidate
-hypertension (>160/95)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study if sustained release methylphenidate combined with psychosocial treatment (relapse prevention) in amphetamine dependent individuals with ADHD significantly lowers the risk for relapse to substance abuse compared with placebo and psychosocial treatment (relapse prevention) <br><br>Primary outcome variable: precentage of urine samples with no trace of drugs of abuse (amphetamines, opioids, benzodiazepines, THC, cocaine, dextropropoxifen, buprenorphine) ;Secondary Objective: Secondary outcome variables: relapse to crime (readmission to prison or other legal action for criminal offence, self-reported criminality); self-reported reduction in ADHD-symptoms; plasma concentration of methylphenidate; clinician reported reduction in ADHD-symptoms; symptoms of depression and anxiety; self-reported drug-craving;Primary end point(s): The precentage of urine samples without trace of drugs (amphetamines, opioids, bensodiazepines, THC, cocaine, dextropropoxiphene).
- Secondary Outcome Measures
Name Time Method