Major finding: ADHD symptoms improved and substance use declined with CBT, regardless of whether adolescents received OROS-MPH or placebo.
Source of data: A randomized controlled trial with 303 adolescents with ADHD and a substance use disorder.
Disclosures: The trial was sponsored by the National Institute of Drug Abuse. The lead investigator reported no conflicts of interest.
LOS ANGELES – Psychostimulant treatment did not outperform placebo when structured cognitive-behavioral therapy was integrated into the treatment of adolescents with attention-deficit/hyperactivity disorder and substance use disorders.
In a 16-week, randomized, placebo-controlled trial, ADHD symptoms significantly improved and substance use declined regardless of whether adolescents received OROS-MPH (Concerta) or placebo, Dr. Paula Riggs said at the annual meeting of the American Academy of Addiction Psychiatry.
Rather than being seen as a negative trial, the study appears to speak to the usefulness of structured, individualized weekly CBT, said Dr. Riggs, the primary investigator of the 11-center trial sponsored by the National Institute of Drug Abuse and professor of psychiatry at the University of Colorado, Denver.
The trial enrolled 303 adolescents aged 13–18 who met DSM-IV criteria for ADHD and for at least substance use disorder (other than nicotine dependence, and excluding current opiate dependence or methamphetamine abuse or dependence).
The average age of participants was 16.5 years. About 80% of the participants were male, and 20% female. Whites constituted 64% of the medication arm and 55% of the placebo arm. Roughly a fourth of the subjects in each group were African American; 15% were Hispanic .
About one-third of subjects had ADHD-inattentive type; 67% had ADHD-combined type; and less than 2%, ADHD-hyperactive type.
Cannabis and alcohol use/dependence were the most commonly represented substance use disorders, although use and/or abuse of hallucinogens, opioids, cocaine, and amphetamines also were reported.
Adolescents with major depression, anxiety disorders, and/or conduct disorder were included in the trial, resulting in a high baseline level of psychopathology among participants. Almost 75% of the subjects completed the trial.
“We wanted to keep this real and generalizable,” Dr. Riggs said.
In the medication arm, 80% of 151 patients were compliant with doses, which were successfully titrated to 72 mg/daily in 96% and sustained at that dose in 86%.
Participants received either the active (titrated) drug or placebo along with weekly, individual CBT using a standardized manual targeting drug abuse.
An intent-to-treat analysis was used to calculate results.
“This was the shocker,” Dr. Riggs said. “We saw a clinically and statistically significant reduction in ADHD symptoms in both groups.”
Symptoms declined 46% in the medication group and 45% in the placebo group.
Parents reported symptom reductions of 26% and 30% in adolescents receiving active medication or placebo on a DSM-IV symptom checklist at 8 weeks, and 24% and 30.9% reductions at 16 weeks.
Past 28-day substance use reports declined by 6.1 days (43%) in the medication arm and 4.9 days (33%) in the placebo arm–a statistically insignificant between-group difference.
Slightly more negative drug screens–3.8 compared with 2.8–were found in adolescents assigned to receive active medication, and this group also showed greater improvements in problem-solving skills and focused-coping skills that had been addressed in CBT, Dr. Riggs reported.
Subjects deemed by investigators to be “medication responders” had twice as many negative drug screens as nonresponders or those receiving placebo.
Titrated OROS-MPH was “stunningly safe and well-tolerated” in the trial, with 11 serious adverse events, 7 of which occurred in the placebo group. The only event seen more frequently in the medication arm was limb injury, an event not considered to be related to the medication.
The trial results were inconsistent with the results of trials pitting psychostimulants against placebo in non–substance-abusing youth.
However, they were consistent with three previous controlled psychostimulant trials in non–substance-abusing adolescents when concurrent CBT was included for subjects in both the medication and placebo arms.
As in this trial, significant reductions were seen in ADHD in both groups, but with no significant advantage to medication over placebo.