Methylphenidate in the treatment of amphetamine dependence: a double-blind randomised, placebo-controlled trial
| ISRCTN | ISRCTN54619615 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54619615 |
| Secondary identifying numbers | 64/2003 |
- 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
Scientific
Niuvanniemi Hospital
Kuopio
FI-70240
Finland
| jari.tiihonen@niuva.fi |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Methylphenidate |
| Primary outcome measure | 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 measures | Retention in treatment. |
| Overall study start date | 01/03/2004 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
FI-70240
Finland
Sponsor information
University of Kuopio (Finland)
University/education
University/education
c/o Jari Tiihonen
Niuvanniemi Hospital
Kuopio
FI-70240
Finland
| jari.tiihonen@niuva.fi | |
| Website | http://www.uku.fi/english/ |
"ROR" |
https://ror.org/00cyydd11 |
Funders
Funder type
Hospital/treatment centre
Current sources of funding as of 24/04/2008:
No information available
University Hospital of Helsinki (Finland) - 67,000 Euros
No information available
National Public Health Institute (Finland) - 123,500 Euros
No information available
Niuvanniemi Hospital (Finland) - 30,000 Euros
No information available
Department of Forensic Medicine, Faculty of Medicine, University of Helsinki (Finland) - 15,000 Euros
No information available
Academy of Finland (Finland) - 81,000 Euros
No information available
Total: 316,500 Euros
No information available
Previous sources of funding:
No information available
University Hospital of Helsinki (Finland) - research assistant: 24,000 Euros; basic laboratory analysis: 13,000 Euros; randomisation and drug capsulation: 30,000 Euros
No information available
National Public Health Institute (Finland) - drug analysis: 67,000 Euros; database and statistics: 123,500 Euros
No information available
Niuvanniemi Hospital (Finland) - 30,000 Euros
No information available
Department of Forensic Medicine, Faculty of Medicine, University of Helsinki (Finland) - 15,000 Euros
No information available
Total: 235,500 Euros
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 | 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 |
Editorial Notes
26/10/2022: Internal review.
