Condition category
Mental and Behavioural Disorders
Date applied
26/02/2008
Date assigned
21/04/2008
Last edited
11/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Johan Franck

ORCID ID

Contact details

Karolinska Institute
Magnus Huss
bv
Stockholm
171 76
Sweden

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

http://www.beroendecentrum.com

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

  1. 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.

Additional files

Editorial Notes