Methylphenidate in the treatment of amphetamine dependence: a double-blind randomised, placebo-controlled trial

ISRCTN	ISRCTN54619615
DOI	https://doi.org/10.1186/ISRCTN54619615
Protocol serial number	64/2003
Sponsor	University of Kuopio (Finland)
Funders	Current sources of funding as of 24/04/2008:, University Hospital of Helsinki (Finland) - 67,000 Euros, National Public Health Institute (Finland) - 123,500 Euros, Niuvanniemi Hospital (Finland) - 30,000 Euros, Department of Forensic Medicine, Faculty of Medicine, University of Helsinki (Finland) - 15,000 Euros, Academy of Finland (Finland) - 81,000 Euros, Total: 316,500 Euros, Previous sources of funding:, University Hospital of Helsinki (Finland) - research assistant: 24,000 Euros; basic laboratory analysis: 13,000 Euros; randomisation and drug capsulation: 30,000 Euros, National Public Health Institute (Finland) - drug analysis: 67,000 Euros; database and statistics: 123,500 Euros, Niuvanniemi Hospital (Finland) - 30,000 Euros, Department of Forensic Medicine, Faculty of Medicine, University of Helsinki (Finland) - 15,000 Euros, Total: 235,500 Euros

Submission date: 07/09/2005
Registration date: 13/09/2005
Last edited: 26/10/2022

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jari Tiihonen
Scientific

Niuvanniemi Hospital
Kuopio
FI-70240
Finland

Email	jari.tiihonen@niuva.fi

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Methylphenidate in the treatment of amphetamine dependence: a double-blind randomised, placebo-controlled trial
Study objectives	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.
Ethics approval(s)	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
Health condition(s) or problem(s) studied	Amphetamine dependence
Intervention	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.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Methylphenidate
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).
Key secondary outcome measure(s)	Retention in treatment.
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	140
Key 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)
Key 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
Date of first enrolment	01/03/2004
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Finland
New Zealand

Study participating centre

Niuvanniemi Hospital

Kuopio
FI-70240
Finland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Interim results	01/01/2007		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

26/10/2022: Internal review.