Clinical trial of long acting methylphenidate in amphetamine addicts with Attention Deficit Hyperactivity Disorder (ADHD)

ISRCTN	ISRCTN81602628
DOI	https://doi.org/10.1186/ISRCTN81602628
Protocol serial number	N/A
Sponsor	Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
Funder	Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)

Submission date: 26/02/2008
Registration date: 21/04/2008
Last edited: 11/06/2010

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

Dr Johan Franck
Scientific

Karolinska Institute
Magnus Huss, bv
Stockholm
171 76
Sweden

Study information

Primary study design	Interventional
Study design	Prospective randomised double-blind placebo controlled single-centre trial.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MAHA
Study objectives	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?
Ethics approval(s)	Regional ethics committee in Stockholm, approved on 23/06/2004 (Dnr 04-396/1). Amendment approved on 17/02/2005 (Dnr 2005/200-32)
Health condition(s) or problem(s) studied	Attention deficit hyperactivity disorder
Intervention	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.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	methylphenidate (Concerta®)
Primary outcome measure(s)	Reduction in self rated ADHD symptoms, assessed using the Conners' Adult ADHD Rating Scale (CAARS) at baseline and once a week for 12 weeks
Key secondary outcome measure(s)	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)
Completion date	25/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	24
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	14/02/2006
Date of final enrolment	25/06/2007

Locations

Countries of recruitment

Sweden

Study participating centre

Karolinska Institute

Stockholm
171 76
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2010		Yes	No