Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
MAHA
Study hypothesis
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
Regional ethics committee in Stockholm, approved on 23/06/2004 (Dnr 04-396/1). Amendment approved on 17/02/2005 (Dnr 2005/200-32)
Study design
Prospective randomised double-blind placebo controlled single-centre trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
methylphenidate (Concerta®)
Primary outcome measures
Reduction in self rated ADHD symptoms, assessed using the Conners' Adult ADHD Rating Scale (CAARS) at baseline and once a week for 12 weeks
Secondary outcome measures
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)
Overall trial start date
14/02/2006
Overall trial end date
25/06/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
24
Participant 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
Recruitment start date
14/02/2006
Recruitment end date
25/06/2007
Locations
Countries of recruitment
Sweden
Trial participating centre
Karolinska Institute
Stockholm
171 76
Sweden
Sponsor information
Organisation
Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
Sponsor details
Box 17914
Stockholm
118 95
Sweden
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
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
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20015599
Publication citations
-
Results
Konstenius M, Jayaram-Lindström N, Beck O, Franck J, Sustained release methylphenidate for the treatment of ADHD in amphetamine abusers: a pilot study., Drug Alcohol Depend, 2010, 108, 1-2, 130-133, doi: 10.1016/j.drugalcdep.2009.11.006.