November 20, 2009 (Honolulu, Hawaii) — Long-acting psychostimulant medication to treat adolescents with attention-deficit/hyperactivity disorder (ADHD) who have co-occurring substance use disorders (SUDs) appears to be safe even if the adolescents have not achieved abstinence.
Results of the recently completed large, multisite randomized controlled trial also indicate that long-acting psychostimulant medication for ADHD appears to carry a low risk of abuse or diversion liability in adolescents concurrently receiving outpatient drug treatment.
Presented here for the first time at the American Academy of Child & Adolescent Psychiatry 56th Annual Meeting, investigators from the University of Colorado at Denver reported osmotic-release methylphenidate (OROS-MPH) appears to have similar safety and tolerability in adolescents with SUDs as it does in children and adolescents with ADHD who do not have co-occurring SUDs.
As many as half of adolescents in substance abuse treatment programs have ADHD. These individuals have more severe substance abuse, behavioral problems, and poorer treatment retention and outcomes than individuals with drug misuse or dependence who do not have ADHD.
According to the study's principal investigator, Paula Riggs, MD, ADHD often goes untreated in adolescents with substance abuse, and this has been associated with poorer treatment outcomes.
"Understandably, clinicians have been reluctant to treat ADHD in substance-abusing adolescents because of the lack of research on the safety and efficacy of psychostimulants and other medications in adolescents with substance use disorders," Dr. Riggs told Medscape Psychiatry.
To evaluate the safety and efficacy of OROS-MPH plus cognitive behavioral therapy (CBT) compared with CBT plus placebo for the reduction of ADHD symptoms and substance use in adolescents, the researchers randomized 303 participants to 1 of the 2 study arms.
Participants were aged 13 to 18 years, met Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) criteria for ADHD, and scored 22 or higher on the baseline ADHD symptom checklist. Participants also met DSM-IV criteria for at least 1 nonnicotine SUD, excluding methamphetamine and opioid abuse and/or dependence.
Individuals in both treatment groups received weekly 50- to 60-minute, individual CBT. In addition, participants received OROS-MPH titrated to a maximum fixed dose of 72 mg/day or placebo.
Significant Symptom Reduction
Of the total study group 75% completed the trial. Overall, more than 90% of participants achieved the targeted daily dose of 72 mg. Medication compliance and CBT session attendance was 79% and 70%, respectively, with no differences in these outcomes between the 2 study groups.
The researchers also reported that despite nonabstinence in most participants OROS-MPH had an excellent safety profile with good tolerability. Psychostimulant-related adverse effects, including increased heart rate, excoriation, and nervousness, were greater in adolescents treated with OROS-MPH but were mostly mild and transient and did not require dose reduction or medication discontinuation.
The study showed a clinically and statistically significant reduction in ADHD symptoms in those treated with OROS-MPH plus CBT of 46%. However, there was no separation between the 2 treatment groups because of a similar 45% reduction in the placebo plus CBT treatment group based on the study's primary outcome measure of adolescent-reported ADHD symptoms on the DSM-IV ADHD symptom checklist.
However, parent ratings were lower with OROS-MPH compared with placebo at 8 weeks (P < .02) and 16 weeks (P < .0015). Adolescents treated with OROS-MPH plus CBT also reported significant improvement in their problem-solving ability (P < .0023) and focused coping skills (P < .023) compared with those treated with placebo plus CBT, who reported no change on these measures from baseline.
Similarly, there was a clinically and statistically significant reduction in the number of days of past-month drug use in both treatment groups but no difference between groups. However, adolescents treated with OROS-MPH plus CBT also had significantly more negative drug screen results compared with those treated with placebo plus CBT (P < .05).
Greater Role for CBT?
Taken together, said Dr. Riggs, the study results are mixed but indicate that treating ADHD with OROS-MPH plus CBT may have some added benefit over placebo plus CBT.
"The comparable reduction in ADHD symptoms [in both study groups] may be an indication that cognitive behavioral therapy received by participants in both groups may have contributed to ADHD symptom reduction. Similar findings have been reported in adults treated with psychostimulant medication for ADHD who were concurrently receiving individual CBT for substance abuse,” said Dr. Riggs.
She added that other studies have also reported the effectiveness of CBT in reducing ADHD symptoms in individuals without SUDs.
"I think that the most important clinical implications of this study may be that OROS-MPH, and possibly other long-acting psychostimulant medications, appears to be safe and well tolerated in nonabstinent adolescents who are concurrently enrolled in substance treatment and who receive regular safety and compliance monitoring, " said Dr. Riggs.
However, she said, in the context of individual CBT for SUD, there may be a significant reduction in ADHD symptoms without medication. "If ADHD symptoms do not significantly improve by the end of the first month of treatment, our data suggest that OROS-MPH is safe and well tolerated and should be considered even if the adolescent has not yet achieved abstinence in substance abuse treatment," she added.
The reduction in ADHD symptoms in this study was comparable or superior to results of controlled trials of psychostimulant medication vs placebo in children and adolescents with ADHD but without SUD, she said.
The reduction in drug use, treatment compliance, and treatment completion were comparable or superior to that reported for other evidence-based substance treatments in adolescents with less severe SUD and psychopathologic disorders, she noted. Dr. Riggs also pointed out that study participants had severe psychopathologic disorders, with an average of 2 nontobacco substance abuse or dependence diagnoses. In addition to ADHD, 13% had depression and 50% had conduct disorder.
"More research is needed, of course, but if replicated, the results of this study add to a growing body of research indicating that individual CBT may be a "best match" psychotherapeutic treatment modality for adolescents and young adults with co-occurring substance abuse and psychiatric disorders.
"Results of this study also add to a growing body of research supporting the safety and tolerability of specific pharmacotherapeutic agents that may be used in adolescents with co-occurring disorders," said Dr. Riggs.
The study was funded by the National Institute on Drug Abuse. Dr. Riggs has disclosed no relevant financial relationships.
American Academy of Child & Adolescent Psychiatry (AACAP) 56th Annual Meeting: Abstracts 29 and 29.1. Presented October 30, 2009.
Medscape Medical News © 2009 Medscape, LLC
Send press releases and comments to email@example.com.
Cite this: Psychostimulant Medication Safe in Adolescents With ADHD and Substance Use Disorders - Medscape - Nov 20, 2009.