Methylphenidate ADHD and SUD Study

This project will contribute to the treatment-possibilities of adult ADHD
patients with comorbid Substunce Use Disorders. ADHD is an invalidating,
chronic and highly prevalent neurobiological disorder. The prevalence in
children is 3-6%, in adults 1-3%. Most adult ADHD patients do have comorbid
pscyhiatric disorders, of which Substance Use Disorders (SUD) is an important
one.
ADHD is a highly prevalent comorbid disorder in adults with SUD; research in
this area gives a range of this prevalence of 15-25% (Wilens, 2004)

- short-term efficacy of MPH on ADHD symptomatology in adult male SUD patients
with ADHD.
- short-term influence of MPH on abstinence and drug use
- short-term influence of MPH on cocaine craving
- safety and adverse effects of MPH in this patient group.

A-B-C-D design
randomised, double-blind, multiphasic study with placebo lead-in:
each participant receives in randomised sequence: 3 treatment phases (A-B-C)
and 1 placebo phase (D)
duration: 9 weeks = placebo lead-in (1 week) + 4 phases (4 x 2 weeks)

evaluation: 10 times 1 baseline, 2 day 7 of placebo lead in, 3-10 day 7 and
14 of each phase

active treatment: methylphenidate (MPH) in 3 different dosage schedules
A = 7,5 mg 4 times a day (every 3 hours) B = 12,50 mg 4 times a
day (every 3 hours)
C = 20 mg 4 times a day (every 3 hours)
D = Placebo

See study design

Burden diagnoses (adhd, SUD, comorbid disorders: extra intensive procedure
(partly comparable to care as usual) approximately3 hours.
Burden trial 9x 140 minutes.

Burden participation: later start of normal treatment procedures
Possible adverse effects- common to methylfenidate

Risks: Recent publications show that methylfenidat can safely be used in the
treatment of ADHD patients with SUD.

Publications:
* Levin FR, Evans SM, Brooks DJ, Garawi F. Treatment of cocaine dependent
treatment seekers with adult ADHD: double-blind comparison of methylphenidate
and placebo. Drug Alcohol Depend. 2007 Feb 23;87(1):20-9.
* Levin FR, Evans SM, Brooks DJ, Kalbag AS, Garawi F, Nunes EV. Treatment of
methadone-maintained patients with adult ADHD: double-blind comparison of
methylphenidate, bupropion and placebo. Drug Alcohol Depend. 2006 Feb
1;81(2):137-48.
* Carpentier PJ, de Jong CA, Dijkstra BA, Verbrugge CA, Krabbe PF. A controlled
trial of methylphenidate in adults with attention deficit/hyperactivity
disorder and substance use disorders. Addiction. 2005 Dec;100(12):1868-74.

* Winhusen, T. et al 2006. Methylphenidate and cocaine: A placebo-controlled
drug interaction study. Pharmacology, Biochemistry and Behavior 85 29-38