Contact information
Type
Scientific
Primary contact
Dr Johan Franck
ORCID ID
Contact details
Karolinska Institute
Department of Clinical Neurosciences
M4:02
Stockholm
17176
Sweden
-
johan.franck@ki.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MKJF001
Study information
Scientific title
Clinical trial of sustained release methylphenidate for Attention Deficit Hyperactivity Disorder (ADHD) in adult criminal offenders with amphetamine addiction
Acronym
Study hypothesis
Attention Deficit Hyperactivity Disorder (ADHD) is a common childhood condition that in many cases persists into adulthood. Approximately 1 - 2 % of the adult population is affected. ADHD is characterised by problems with attention, hyperactivity and impulsivity and leads to disabling difficulties in many areas of life. Additional psychiatric problems are common, abuse of drugs and alcohol being one of the most frequent. An estimated 30% of the individuals with substance use have ADHD. Amphetamine use is a major problem in Sweden and internationally. Many of amphetamine dependent individuals are also involved in criminal activity and relapse rate in criminality is very high for the abuse population. So far there is no evidence-based pharmacotherapy for amphetamine dependency. Few studies have addressed the question of treating ADHD with stimulants in substance dependent population.
Hypothesis:
Does sustained release methylphenidate combined with psychosocial treatment (relapse prevention) in amphetamine dependent individuals with ADHD significantly lower the risk for relapse to substance abuse compared with placebo and psychosocial treatment (relapse prevention)?
On 18/11/2010 the overall trial end date was changed from 30/06/2009 to 30/09/2011.
Ethics approval
Ethics approval received from the Regional Ethics Committee in Stockholm on the 12/06/2006 (ref: 2006/585-31/2). Amendment approved on the 27/09/2006 (ref: 2006/1103-32).
Study design
Single-centre double-blind randomised placebo-controlled with parallel groups
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Attention Deficit Hyperactivity Disorder (ADHD)
Intervention
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 psychologist and a physician. Individuals who meet the study criteria undergo a neuropsychological assessment and baseline measurements are completed. Subjects also undergo a physical examination, checking their blood pressure; 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.
Subject are randomised into sustained release Methylphenidate (MPH) group or placebo group. The randomisation is handled by an independent pharmacist. Starting dose is 18 mg with 19-day titration to maximum dose of 180 mg. For patients who do not tolerate dose increase the dosage will be adjusted and continued at the tolerated level.
After their release subjects attend an out patient clinic twice a week and are seen by a research nurse. At each visit subjects collect the medication needed until next visit. They are also required to produce a urine specimen and fill in forms or take tests required for that visit. Once a week all subjects receive cognitive behaviour therapy (Relapse Prevention [RP]). RP starts at week 1 while subjects are still in prison and continues for 12 weeks. At weeks 13 - 24 subjects meet a psychologist/coach every fortnight for help in practical matters.
Intervention type
Drug
Phase
Not Applicable
Drug names
Methylphenidate
Primary outcome measures
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 outcome measures
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)
Overall trial start date
12/04/2007
Overall trial end date
30/09/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
54
Participant 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
Recruitment start date
12/04/2007
Recruitment end date
17/05/2011
Locations
Countries of recruitment
Sweden
Trial participating centre
Karolinska Institute
Stockholm
17176
Sweden
Sponsor information
Organisation
Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
Sponsor details
Box 11895
Stockholm
11895
Sweden
-
maija.konstenius@sll.se
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Psychiatric Services Coordination Taskgroup (Nationell Psykiatri Samordning) (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary