Condition category
Mental and Behavioural Disorders
Date applied
07/09/2005
Date assigned
13/09/2005
Last edited
24/04/2008
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

Prof Jari Tiihonen

ORCID ID

Contact details

Niuvanniemi Hospital
Kuopio
FI-70240
Finland
jari.tiihonen@niuva.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

64/2003

Study information

Scientific title

Acronym

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Methylphenidate

Primary outcome measures

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 trial start date

01/03/2004

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

Participant 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

Recruitment start date

01/03/2004

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Finland, New Zealand

Trial participating centre

Niuvanniemi Hospital
Kuopio
FI-70240
Finland

Sponsor information

Organisation

University of Kuopio (Finland)

Sponsor details

c/o Jari Tiihonen
Niuvanniemi Hospital
Kuopio
FI-70240
Finland
jari.tiihonen@niuva.fi

Sponsor type

University/education

Website

http://www.uku.fi/english/

Funders

Funder type

Hospital/treatment centre

Funder name

Current sources of funding as of 24/04/2008:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University Hospital of Helsinki (Finland) - 67,000 Euros

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Public Health Institute (Finland) - 123,500 Euros

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Niuvanniemi Hospital (Finland) - 30,000 Euros

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department of Forensic Medicine, Faculty of Medicine, University of Helsinki (Finland) - 15,000 Euros

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Academy of Finland (Finland) - 81,000 Euros

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Total: 316,500 Euros

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Previous sources of funding:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University Hospital of Helsinki (Finland) - research assistant: 24,000 Euros; basic laboratory analysis: 13,000 Euros; randomisation and drug capsulation: 30,000 Euros

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Public Health Institute (Finland) - drug analysis: 67,000 Euros; database and statistics: 123,500 Euros

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Niuvanniemi Hospital (Finland) - 30,000 Euros

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department of Forensic Medicine, Faculty of Medicine, University of Helsinki (Finland) - 15,000 Euros

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Total: 235,500 Euros

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

Interim results in http://www.ncbi.nlm.nih.gov/pubmed/17202560

Publication citations

  1. Interim results

    Tiihonen J, Kuoppasalmi K, Föhr J, Tuomola P, Kuikanmäki O, Vorma H, Sokero P, Haukka J, Meririnne E, A comparison of aripiprazole, methylphenidate, and placebo for amphetamine dependence., Am J Psychiatry, 2007, 164, 1, 160-162, doi: 10.1176/appi.ajp.164.1.160.

Additional files

Editorial Notes