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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN54619615

Enrollment

140

Registered

2005-09-13

Start date

2004-03-01

Completion date

Unknown

Last updated

2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amphetamine dependence Mental and Behavioural Disorders Amphetamine dependence

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:

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
Retention in treatment.	—

Countries

Finland, New Zealand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026