Amphetamine dependence
Conditions
Interventions
Trade Name: Concerta 36 mg depottablett
Product Name: methylphenidate
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Stockholm Centre for Dependency Disorders
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or a non-pregnant/non-nursing female between 18 and 55 years of age • Fulfills DSM-IV/DSM-5 criteria for amphetamine dependence * Fulfills DSM-IV/DSM-5 criteria for ADHD • Minimum 7 maximum 90 amphetamine-free days before inclusion • IQ estimate > 75 • Signed informed consent • Be willing to comply with study protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Current use of any psychoactive medication • Fulfills DSM-IV diagnosis of any other substance dependence disorder (except nicotine) the past 6 month period before inclusion • Fulfills DSM-IV/DSM-5 diagnosis of any major psychiatric illness e.g. schizophrenia, bipolar disorder, and major depression • Tourette’s syndrome • Presence of any serious somatic disorder (e.g. heart condition, stroke) • Use of any illegal drugs for the last 7 days. • Presence of drug of abuse in urine at inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To better understand the effect and the mechanism of MPH in this population we aim to study the medication effect on impulse inhibition and other executive functioning –some of the core deficits in both ADHD and in SUD. ;Secondary Objective: In order to study the dose response relationship for MPH, plasma concentrations will be monitored. ;Primary end point(s): •Effect of 180 mg of methylphenidate on impulsivity compared to no medication at baseline: measured as Stop Signal Reaction Time and Spatial Working Memory in CANTAB. ;Timepoint(s) of evaluation of this end point: LPLV | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Effect of 180mg of methylphenidate on impulsivity, processing speed and attention compared to baseline: measured with cognitive tests in CANTAB and with AQT • Effect of 72 mg on impulsivity, spatial working memory, processing speed and attention compared to baseline: measured with cognitive tests in CANTAB and with AQT. • ADHD symptoms measured with self-rating scale ASRS/ CAARS • Hyperactivity measured with Qb+ Test • Craving measured with VAS-scale • Adverse Events (questionnaire) • Depression measured with Montgomery- Asberg Depression Rating Scale (MADRS) • Psychiatric symptoms measured by Outcome Questionnaire 45 • Life time alcohol and amphetamine use measured by adapted Life time drinking history (LDH) • Comparison of results in CANTAB between individuals with ADHD+ SUD and with ADHD - SUD at 72 mg ;Timepoint(s) of evaluation of this end point: LPLV | — |
Countries
Sweden
Contacts
Public ContactMagnus Huss mottagningen
Stockholm Centre for Dependency Disorders
Outcome results
None listed