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.
Conditions
Interventions
Trade Name: Concerta
Product Name: Concerta
Pharmaceutical Form: Capsule*
INN or Proposed INN: methylphenidate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18-
P
Sponsors
Addiction Center Stockholm
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: -- 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 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). | — |
Countries
Sweden
Outcome results
None listed