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Methylphenidate in the treatment of amphetamine dependence: a double-blind randomised, placebo-controlled trial
ISRCTN ISRCTN54619615
DOI 10.1186/ISRCTN54619615
ClinicalTrials.gov identifier
EudraCT number
Public title Methylphenidate in the treatment of amphetamine dependence: a double-blind randomised, placebo-controlled trial
Scientific title
Acronym N/A
Serial number at source 64/2003
Study hypothesis Please note that as of 24/04/2008 this record was extensively updated due to the omission of the aripiprazole arm from this study after a discussion with the ethical committee. All updates can be seen under the relevant field, under the update date of 24/04/2008. The previous title of the trial was 'Aripiprazole and methylphenidate in the treatment of amphetamine dependence: a double-blind randomised, placebo-controlled trial'. The following changes have also been made:
1. The anticipated end date of this trial was extended to 31/12/2009, the previous anticipated end date was 31/12/2007
2. The current target number of participants has been changed to 140, the previous target number of participants was 210

Current hypothesis as of 24/04/2008:
To study if methylphenidate is more effective than placebo in reducing amphetamine use.

Previous hypothesis:
To study if aripiprazole or methylphenidate is more effective than placebo in reducing amphetamine use.
Lay summary
Ethics approval Ethics approval received from:
1. Finland: Ethics Committee for Paediatrics, Adolescent Medicine and Psychiatry, Hospital District of Helsinki and Uusimaa on the 18th October 2005 (ref: 79/D7/2005)
2. New Zealand: Northern X Regional Ethics Committee, Auckland on the 8th October 2007
Study design Randomised controlled trial
Countries of recruitment Finland, New Zealand
Disease/condition/study domain Amphetamine dependence
Participants - inclusion criteria 1. Amphetamine (or methamphetamine) dependence (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition [DSM-IV])
2. Aged between 18 - 65 years, either sex
3. Recent and accustomed amphetamine (methamphetamine) use (urine analysis positive)
Participants - exclusion criteria Current exclusion criteria as of 24/04/2008:
1. Simultaneous participation in other treatment (intervention) studies
2. Uncontrolled use of other substances (e.g. alcohol) requiring medical treatment
3. Some other substance than amphetamine/methamphetamine as the primary drug
4. Another significant mental disorder or risk of suicide
5. Mental disorder which needs special treatment
6. Significant brain, thyroid, renal, gastrointestinal or cardiovascular disease
7. Epilepsy
8. Glaucoma
9. Tourette disorder or tics
10. Clinically significant liver disease
11. Female gender without adequate pregnancy prevention
12. Pregnancy
13. Previous methylphenidate abuse

Previous exclusion criteria:
1. Simultaneous participation in other treatment (intervention) studies
2. Having other native language than Finnish
3. Uncontrolled use of other substances (e.g. alcohol) requiring medical treatment
4. Some other substance than amphetamine/methamphetamine as the primary drug
5. Another significant mental disorder or risk of suicide
6. Mental disorder which needs special treatment
7. Significant brain, thyroid, renal, gastrointestinal or cardiovascular disease
8. Epilepsy
9. Glaucoma
10. Tourette disorder or tics
11. Clinically significant liver disease
12. Female gender without adequate pregnancy prevention
13. Pregnancy
14. Previous methylphenidate abuse
Anticipated start date 01/03/2004
Anticipated end date 31/12/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 140
Interventions Current interventions as of 24/04/2008:
Methylphenidate SR 54 mg/d or placebo. Duration of treatment and follow-up was 22 weeks.

Previous interventions:
Aripiprazole 15 mg/d or methylphenidate SR 54 mg/d or placebo.
Primary outcome measure(s) Current primary outcome measure(s) as of 24/04/2008:
1. Proportion of positive amphetamine (methamphetamine) urine samples (intention-to-treat [ITT] analysis; all missing samples considered as positive)
2. Quantitative amphetamine/methamphetamine urine analysis (ITT analysis)

Previous primary outcome measure(s):
Proportion of positive amphetamine (methamphetamine) urine samples (intention-to-treat analysis; all missing samples considered as positive).
Secondary outcome measure(s) Retention in treatment.
Sources of funding Current sources of funding as of 24/04/2008:
1. University Hospital of Helsinki (Finland) - 67,000 Euros
2. National Public Health Institute (Finland) - 123,500 Euros
3. Niuvanniemi Hospital (Finland) - 30,000 Euros
4. Department of Forensic Medicine, Faculty of Medicine, University of Helsinki (Finland) - 15,000 Euros
5. Academy of Finland (Finland) - 81,000 Euros
Total: 316,500 Euros

Previous sources of funding:
1. University Hospital of Helsinki (Finland) - research assistant: 24,000 Euros; basic laboratory analysis: 13,000 Euros; randomisation and drug capsulation: 30,000 Euros
2. National Public Health Institute (Finland) - drug analysis: 67,000 Euros; database and statistics: 123,500 Euros
3. Niuvanniemi Hospital (Finland) - 30,000 Euros
4. Department of Forensic Medicine, Faculty of Medicine, University of Helsinki (Finland) - 15,000 Euros
Total: 235,500 Euros
Trial website
Publications Interim results in http://www.ncbi.nlm.nih.gov/pubmed/17202560
Contact name Prof  Jari  Tiihonen
  Address Niuvanniemi Hospital
  City/town Kuopio
  Zip/Postcode FI-70240
  Country Finland
  Email jari.tiihonen@niuva.fi
Sponsor University of Kuopio (Finland)
  Address c/o Jari Tiihonen
Niuvanniemi Hospital
  City/town Kuopio
  Zip/Postcode FI-70240
  Country Finland
  Email jari.tiihonen@niuva.fi
  Sponsor website: http://www.uku.fi/english/
Date applied 07/09/2005
Last edited 24/04/2008
Date ISRCTN assigned 13/09/2005
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