Condition category
Mental and Behavioural Disorders
Date applied
03/09/2007
Date assigned
26/10/2007
Last edited
12/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.beroendecentrum.com/

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

Publication citations

Additional files

Editorial Notes