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ISRCTN
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ISRCTN81602628
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ClinicalTrials.gov identifier
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Public title
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Clinical trial of long acting methylphenidate in amphetamine addicts with Attention Deficit Hyperactivity Disorder (ADHD)
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Scientific title
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Acronym
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MAHA
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Serial number at source
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N/A
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Study hypothesis
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ADHD is a pervasive childhood disorder highly prevalent in substance users. It is characterized by disabling problems of inattention, impulsivity and hyperactivity. ADHD is a known risk factor for substance use disorders (SUD) and has a negative effect on treatment outcome. Amphetamine is one of the most commonly used illicit drugs world wide causing severe physical and mental health problems for the individuals and their families and a huge financial cost for the communities.
Study hypothesis:
Does long acting methylphenidate (Concerta®) in combination with skills training reduce ADHD symptoms in amphetamine addicts with ADHD compared with placebo in combination with skills training?
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Ethics approval
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Regional ethics committee in Stockholm, approved on 23/06/2004 (Dnr 04-396/1). Amendment approved on 17/02/2005 (Dnr 2005/200-32)
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Study design
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Prospective randomised double-blind placebo controlled single-centre trial.
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Countries of recruitment
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Sweden
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Disease/condition/study domain
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Attention deficit hyperactivity disorder
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Participants - inclusion criteria
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1. Male or female 18 to 65 years
2. Written consent
3. Amphetemine (amph) dependence according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)
4. Used apmh on minimum 10 days during the year before inclusion
5. ADHD according to DSM-IV
6. Living in Stockholm area
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Participants - exclusion criteria
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1. Dependence (current or past) of opioids, cannabis or benzodiazepines
2. Have used opioids within 3 months before screening
3. Other serious psychiatric conditions such as suicidality or psychosis
4. Current treatment with benzodiazepines, antidepressants or neuroleptics
5. Heart condition or stroke or any other medical condition that is considered a risk
6. Pregnancy or breastfeeding
8. IQ <75
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Anticipated start date
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14/02/2006
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Anticipated end date
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25/06/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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24
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Interventions
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Participants are required to stay abstinent of any substance for minimum two weeks prior the inclusion.
Intervention group: Long acting methylphenidate (Concerta®) for 12 weeks, starting dose of 18 mg with 10-day titration up to max 72 mg + skills training
Control group: Placebo for 12 weeks + skills training
For subjects who do not tolerate the dose increase the dosage is adjusted and continued at the tolerated level.
Skills training: The main features in the treatment is assessing ADHD-symptoms and developing strategies to manage them such as exercises in mindfulness. Themes for the sessions are e.g., impulsivity, self-control, managing craving, risk situations for relapse.
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Primary outcome measure(s)
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Reduction in self rated ADHD symptoms, assessed using the Conners' Adult ADHD Rating Scale (CAARS) at baseline and once a week for 12 weeks
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Secondary outcome measure(s)
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1. Reduction in drug use: urine toxicology at baseline and weeks 4, 8 and 12
2. Observer rated ADHD symptoms, assessed using CAARS at baseline and once a week for 12 weeks
3. Psychiatric symptoms at baseline and weeks 4, 8 and 12
3.1. Self rated craving assessed with Tiffany craving scale
3.2. Change in symptoms of depression and anxiety assessed with Becks inventories
3.3. Stroop test (test of selective attention)
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Sources of funding
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Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
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Trial website
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Publications
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Contact name
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Dr
Johan
Franck
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Address
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Karolinska Institute
Magnus Huss, bv
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City/town
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Stockholm
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Zip/Postcode
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171 76
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Country
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Sweden
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Sponsor
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Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
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Address
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Box 17914
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City/town
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Stockholm
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Zip/Postcode
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118 95
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Country
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Sweden
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Sponsor website:
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http://www.beroendecentrum.com
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Date applied
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26/02/2008
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Last edited
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21/04/2008
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Date ISRCTN assigned
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21/04/2008
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