A randomized controlled trial of pemoline for attention-deficit/hyperactivity disorder in substance-abusing adolescents
Open accessAbstract
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.Method 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.
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Riggs et al. (2004) found a significant between-group effect favoring pemoline for clinician-rated much improved or very much improved ADHD symptom severity at endpoint (p = 0.05), but no effect on parent-rated ADHD symptom severity (p = 0.13), substance use (adolescent-report p = 0.80; urinalysis p = 0.33), or conduct disorder symptoms (p = 0.44).
“the results showed a significant between-group effect in favor of pemoline in terms of the percentage of adolescents with clinician-rated “much improved” or “very much improved” ADHD symptom severity at the study endpoint (p = 0.05), but no effect on parent-rated ADHD symptom severity (p = 0.13), substance use (adolescent-report: p = 0.80; urinalysis: p = 0.33), and CD symptoms (p = 0.44).”
From Treatment of Adolescents with Concurrent Substance Use Disorder and Attention-Deficit/Hyperactivity Disorder: A Systematic Review (2021) · cites this paper as [38]
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Experimental — accuracy not yet measuredThe results of the reviewed randomized trials in adolescents with concurrent ADHD and SUD were equivocal, with contradictory findings between primary and secondary outcome measures for ADHD and SUD, overall negative findings for both ADHD and SUD, and a small sample size.
“Concerning pharmacotherapy, the results of the reviewed randomized trials in adolescents with concurrent ADHD and SUD were equivocal, with contradictory findings between the primary and secondary outcome measures pertaining to ADHD [37,38] and SUD [37], overall negative findings for both ADHD and SUD [39], and a small sample size [36].”
From Treatment of Adolescents with Concurrent Substance Use Disorder and Attention-Deficit/Hyperactivity Disorder: A Systematic Review (2021) · cites this paper as [38]
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- Authors
- Riggs, P. D., Hall, S. K., Mikulich-Gilbertson, S. K., Lohman, M., & Kayser, A.
- Affiliations
- University of Colorado Anschutz (US)
- Corresponding author
- Riggs, Paula D.
- ORCID
- Riggs, Paula D.
- Venue
- Journal of the American Academy of Child & Adolescent Psychiatry
- Publisher
- Elsevier BV
- Published
- 2004-04
- Volume
- 43
- Issue
- 4
- Pages
- 420-429
- ISSN
- 0890-8567 (ISSN-L)
- OpenAlex
- W2008181018
- Cited by
- 89
- References
- 29
- Citations by year
- 2025: 1 · 2024: 2 · 2022: 2 · 2021: 4 · 2020: 5 · 2018: 4 · 2017: 3 · 2016: 4 · 2015: 4 · 2014: 8 · 2012: 4
- FWCI
- 5.39
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of the American Academy of Child & Adolescent Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (5k20da000271-05)
- National Institute on Drug Abuse (1K20DA00271)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Keywords
- pemoline, attention deficit hyperactivity disorder, substance use disorders, conduct disorder, adolescents, psychostimulants, ADHD treatment efficacy, drug safety, liver enzyme monitoring
- MeSH terms
- Adolescent, Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Female, Humans, Male, Pemoline, Safety, Diagnosis, Dual (Psychiatry), Statistics, Nonparametric, Conduct Disorder, Substance-Related Disorders
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