Clinical trial of long acting methylphenidate in amphetamine addicts with Attention Deficit Hyperactivity Disorder (ADHD)
| ISRCTN | ISRCTN81602628 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81602628 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Karolinska Institute
Magnus Huss, bv
Stockholm
171 76
Sweden
Study information
| Study design | Prospective randomised double-blind placebo controlled single-centre trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | methylphenidate (Concerta®) |
| Primary outcome measure | 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 study start date | 14/02/2006 |
| Completion date | 25/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
171 76
Sweden
Sponsor information
Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
Hospital/treatment centre
Hospital/treatment centre
Box 17914
Stockholm
118 95
Sweden
| Website | http://www.beroendecentrum.com |
|---|---|
"ROR" |
https://ror.org/04g380834 |
Funders
Funder type
Hospital/treatment centre
Addiction Centre Stockholm (Beroendecentrum Stockholm) (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
