Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)

ADHD Clinical Trial

Official title:

Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS-MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264797
• Other study ID #: NIDA-CTN-0028
• Secondary ID: 5U10DA013732
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2005
• Last updated: May 2, 2013
• Start date: February 2006
• Est. completion date: October 2008

Study information

• Verified date: May 2013
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Substance Abuse
• Substance-Related Disorders

Intervention

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 (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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Cincinnati	National Institute on Drug Abuse (NIDA), University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD Severity	DSM IV ADHD Rating Scale (ADHD-RS) adolescent informant, ascertained at baseline and weekly throughout the 16 week study. This scale is an 18-item symptom checklist of self-reported adolescent ADHD symptoms. Symptoms are scored as None (0), Mild (1), Moderate (2), and Severe (3), with a summary total of scores for the 18 symptoms. Possible scores range from 0 to 54, with higher scores indicating greater severity. Outcome is measured as the decrease in total severity score over time.	baseline and 20 weeks	Yes
Primary	Substance Use	The change in number of days of substance use from baseline to end of the trial. The number of days of non-tobacco drug/alcohol ascertained using standard timeline follow back (TLFB) procedures.	20 weeks	Yes
Secondary	OROS-MPH Abuse Liability	Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance.	20 weeks	Yes
Secondary	Substance Use Outcomes	The mean number of negative urine drug screens (UDS).	20 weeks	No