Clinical trial of sustained release methylphenidate for Attention Deficit Hyperactivity Disorder (ADHD) in adult criminal offenders with amphetamine addiction
| ISRCTN | ISRCTN77940178 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77940178 |
| Secondary identifying numbers | MKJF001 |
- Submission date
- 03/09/2007
- Registration date
- 26/10/2007
- Last edited
- 12/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Johan Franck
Scientific
Scientific
Karolinska Institute
Department of Clinical Neurosciences
M4:02
Stockholm
17176
Sweden
| johan.franck@ki.se |
Study information
| Study design | Single-centre double-blind randomised placebo-controlled with parallel groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Clinical trial of sustained release methylphenidate for Attention Deficit Hyperactivity Disorder (ADHD) in adult criminal offenders with amphetamine addiction |
| Study objectives | 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(s) | 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). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Methylphenidate |
| Primary outcome measure | 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 study start date | 12/04/2007 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 54 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 12/04/2007 |
| Date of final enrolment | 17/05/2011 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Karolinska Institute
Stockholm
17176
Sweden
17176
Sweden
Sponsor information
Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
Hospital/treatment centre
Hospital/treatment centre
Box 11895
Stockholm
11895
Sweden
| maija.konstenius@sll.se | |
| Website | http://www.beroendecentrum.com/ |
"ROR" |
https://ror.org/04g380834 |
Funders
Funder type
Not defined
Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
No information available
National Psychiatric Services Coordination Taskgroup (Nationell Psykiatri Samordning) (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
