A randomized controlled trial of pemoline for attention-deficit/hyperactivity disorder in substance-abusing adolescents.
OBJECTIVE
In adolescents with substance use disorder (SUD), comorbid attention-deficit/hyperactivity disorder (ADHD) is associated with greater severity of substance abuse, conduct problems, and worse treatment outcomes. Although many controlled trials have established the efficacy of psychostimulants, including pemoline, for ADHD in children and adolescents, none have been conducted in adolescents with SUD. This randomized, placebo-controlled trial, conducted between 1996 and 2000, evaluated the safety and efficacy of pemoline on substance abuse and conduct problems.


METHODS
Sixty-nine adolescents (aged 13-19) with conduct disorder (CD), SUD, and ADHD were recruited from the community and randomly assigned to a 12-week clinical trial of pemoline (n = 35) or placebo (n = 34), titrated over 4 weeks to a single morning dose of 75 to 112.5 mg as tolerated.


RESULTS
Pemoline had greater efficacy than placebo for ADHD as determined by significantly more Clinician's Global Impression-Improvement (CGI-I) ratings of 1 (very much improved) or 2 (much improved) at the study endpoint (n = 69; p <.05). There was also greater reduction in ADHD severity on the parent-rated Conners Hyperactivity-Impulsivity scale in pemoline-treated study completers compared to placebo-treated completers (pemoline, n = 17; placebo, n = 16; p <.01), but no difference between groups in the intent-to-treat analysis (n = 68; p <.13). Substance use did not decline in either group, and there was no difference between groups in baseline to study endpoint change in substance use or CD symptoms. Overall, pemoline was well tolerated, demonstrating a good safety profile and no elevation in liver enzyme levels.


CONCLUSIONS
Pemoline was efficacious for ADHD but did not have an impact on CD or substance abuse in the absence of specific treatment for SUD.
Riggs
Paula D
PD
Department of Psychiatry, University of Colorado School of Medicine, Denver 80262, USA. paula.riggs@uchsc.edu
Hall
Shannon K
SK
Mikulich-Gilbertson
Susan K
SK
Lohman
Michelle
M
Kayser
Ashley
A
D000293:Adolescent; D000328:Adult; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D019955:Conduct Disorder / Q000188:drug therapy*; D017831:Diagnosis, Dual (Psychiatry); D005260:Female; D006801:Humans; D008297:Male; D010389:Pemoline / Q000627:therapeutic use*; D012449:Safety; D018709:Statistics, Nonparametric; D019966:Substance-Related Disorders
D000697:Central Nervous System Stimulants; D010389:Pemoline