Clinical trial NCT00264797: Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
Official title: Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS-MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Substance Abuse
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Colorado, Denver
First posted: 2005-12-13
Enrollment: 303
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of osmotic-release methylphenidate (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD.

Detailed description: Research shows a high prevalence of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents with substance abuse disorders and indicates that they have poorer substance use treatment outcomes and poorer prognosis and risk of persistence and progression of drug use and behavior problems into adulthood. Although research indicates that the majority are not treated for ADHD while in substance treatment, we do not know whether concurrent pharmacotherapy for ADHD will improve treatment outcomes. This Clinical Trials Network (CTN) study will evaluate the efficacy of osmotic-release methylphenidate (OROS-MPH), relative to placebo, in treating ADHD and decreasing substance use in adolescents (13-18 years old) with ADHD and a substance use disorder. Approximately 300 participants will be recruited at 11 sites and randomly assigned to either OROS-MPH or matching placebo for a 16-week treatment period, during which all participants will receive individual cognitive-behavioral therapy as a standardized treatment for substance abuse.

Eligibility criteria: Inclusion Criteria:

* Meet Diagnostic and Statistical Manual for Mental Disorders, 4th Edition (DSM-IV) diagnostic criteria for ADHD
* Meet DSM-IV diagnostic criteria for at least one non-nicotine substance use disorder
* Has a DSM-IV ADHD Symptom Checklist score ≥ 22 derived from the adolescent-completed checklist

Exclusion Criteria:

* Serious medical illness
* History of tic disorder
* Pregnant or breastfeeding
* Meet DSM-IV criteria for current or life-time psychotic disorder
* Meet DSM-IV criteria for current or life-time bipolar disorder
* Requires/or prescribed other concurrent psychotropic medication
* Taking any medications that may produce interactions with OROS-MPH
* Opiate dependence
* Methamphetamine abuse or dependence
* Suicidal risk
* Enrolled in an inpatient, residential, day treatment, or outpatient substance abuse program within 28 days prior to signing consent

Primary outcomes:
measure: ADHD Severity
timeFrame: baseline and 20 weeks
measure: Substance Use
timeFrame: 20 weeks
Secondary outcomes:
measure: OROS-MPH Abuse Liability
timeFrame: 20 weeks
measure: Substance Use Outcomes
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Synergy Treatment Center
state: Colorado
city: Jacksonville
country: United States
facility: Gateway Community Services
state: Florida
city: St. Petersburg
country: United States
facility: Operation PAR, Inc.
state: Florida
city: Baltimore
country: United States
facility: Mountain Manor Treatment Programs
state: Maryland
city: Fall River
country: United States
facility: SSTAR: Stanley Street Treatment & Resources, Inc
state: Massachusetts
city: Kansas City
country: United States
facility: Crittenton
state: Missouri
city: New York City
country: United States
facility: St. Luke's-Roosevelt Hospital, Child and Family Institute
state: New York
city: Paoli
country: United States
facility: Rehab After Work-Life Counseling Services
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Addiction Medicine Services
state: Pennsylvania
city: North Kingstown
country: United States
facility: SSTAR of Rhode Island
state: Rhode Island
city: Columbia
country: United States
facility: LRADAC
state: South Carolina
city: Fort Worth
country: United States
facility: Mental Health and Retardation of Tarrant County
state: Texas
Study officials:
affiliation: University of Colorado, Denver
name: Paula Riggs, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Theresa Winhusen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Riggs PD, Winhusen T, Davies RD, Leimberger JD, Mikulich-Gilbertson S, Klein C, Macdonald M, Lohman M, Bailey GL, Haynes L, Jaffee WB, Haminton N, Hodgkins C, Whitmore E, Trello-Rishel K, Tamm L, Acosta MC, Royer-Malvestuto C, Subramaniam G, Fishman M, Holmes BW, Kaye ME, Vargo MA, Woody GE, Nunes EV, Liu D. Randomized controlled trial of osmotic-release methylphenidate with cognitive-behavioral therapy in adolescents with attention-deficit/hyperactivity disorder and substance use disorders. J Am Acad Child Adolesc Psychiatry. 2011 Sep;50(9):903-14. doi: 10.1016/j.jaac.2011.06.010. Epub 2011 Aug 4.
citation: Tamm L, Trello-Rishel K, Riggs P, Nakonezny PA, Acosta M, Bailey G, Winhusen T. Predictors of treatment response in adolescents with comorbid substance use disorder and attention-deficit/hyperactivity disorder. J Subst Abuse Treat. 2013 Feb;44(2):224-30. doi: 10.1016/j.jsat.2012.07.001. Epub 2012 Aug 11.