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

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) University of Colorado at Denver and Health Sciences Center University of Cincinnati
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00264797

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 III

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate hydrochloride Methylphenidate

U.S. FDA Resources

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

Further study details as provided by National Institute on Drug Abuse (NIDA):

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 ]

Estimated Enrollment:	300
Study Start Date:	February 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Methylphenidate: Active Comparator	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.
Methylphenidate (Placebo): Placebo Comparator	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

Methylphenidate: Active Comparator

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.

Methylphenidate (Placebo): Placebo Comparator

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
Addiction Medicine Services
Pittsburgh, Pennsylvania, United States, 15213
Rehab After Work-Life Counseling Services
Paoli, Pennsylvania, United States, 19301
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

National Institute on Drug Abuse (NIDA)

University of Colorado at Denver and Health Sciences Center

University of Cincinnati

Investigators

Principal Investigator:	Paula Riggs, M.D.	University of Colorado at Denver and Health Sciences Center
Principal Investigator:	Theresa Winhusen, Ph.D.	University of Cincinnati

More Information

Responsible Party:	University of Colorado Health Sciences Center ( Paula Riggs, M.D. )
Study ID Numbers:	NIDA-CTN-0028
Study First Received:	December 10, 2005
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00264797
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Substance-Related Disorders

Methylphenidate
Attention Deficit and Disruptive Behavior Disorders
Disorders of Environmental Origin
Hyperkinesis

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Physiological Effects of Drugs
Central Nervous System Stimulants
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009