Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD) - Full Text View

Purpose

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.

Condition	Intervention	Phase
ADHD Substance Abuse	Drug: Methylphenidate (OROS-MPH) Drug: Methylphenidate (OROS-MPH) - Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS-MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

ADHD severity [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
Substance use [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

OROS-MPH abuse liability [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
Substance use treatment outcomes [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Enrollment:	303
Study Start Date:	February 2006
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Methylphenidate	Drug: Methylphenidate (OROS-MPH) Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
Placebo Comparator: Methylphenidate (Placebo)	Drug: Methylphenidate (OROS-MPH) - Placebo Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.

Arms

Assigned Interventions

Active Comparator: Methylphenidate

Drug: Methylphenidate (OROS-MPH)

Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.

Placebo Comparator: Methylphenidate (Placebo)

Drug: Methylphenidate (OROS-MPH) - Placebo

Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.

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

Ages Eligible for Study:	13 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264797

Locations

United States, Colorado
Synergy Treatment Center
Denver, Colorado, United States, 80219
United States, Florida
Gateway Community Services
Jacksonville, Florida, United States, 32211
Operation PAR, Inc.
St. Petersburg, Florida, United States, 33709
United States, Maryland
Mountain Manor Treatment Programs
Baltimore, Maryland, United States, 21229
United States, Massachusetts
SSTAR: Stanley Street Treatment & Resources, Inc
Fall River, Massachusetts, United States, 02720-6009
United States, Missouri
Crittenton
Kansas City, Missouri, United States, 64134
United States, New York
St. Luke's-Roosevelt Hospital, Child and Family Institute
New York City, New York, United States, 10025
United States, Pennsylvania
Rehab After Work-Life Counseling Services
Paoli, Pennsylvania, United States, 19301
Addiction Medicine Services
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
SSTAR of Rhode Island
North Kingstown, Rhode Island, United States, 02852
United States, South Carolina
LRADAC
Columbia, South Carolina, United States, 29205
United States, Texas
Mental Health and Retardation of Tarrant County
Fort Worth, Texas, United States, 76107

Sponsors and Collaborators

University of Cincinnati

National Institute on Drug Abuse (NIDA)

University of Colorado, Denver

Investigators

Principal Investigator:	Paula Riggs, M.D.	University of Colorado, Denver
Principal Investigator:	Theresa Winhusen, Ph.D.	University of Cincinnati

More Information

No publications provided by University of Cincinnati

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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. Epub 2011 Aug 4.

Responsible Party:	Theresa Winhusen, Associate Professor, University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00264797 History of Changes
Other Study ID Numbers:	NIDA-CTN-0028, 5U10DA013732
Study First Received:	December 10, 2005
Last Updated:	July 13, 2012
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Substance-Related Disorders
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Methylphenidate

Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013