Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5U10DA013732 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of Colorado, Denver | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate | Active Comparator |
| |
| Methylphenidate (Placebo) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate (OROS-MPH) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| OROS-MPH Abuse Liability | Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance. | 20 weeks |
| Substance Use Outcomes | The mean number of negative urine drug screens (UDS). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paula Riggs, M.D. | University of Colorado, Denver | Principal Investigator |
| Theresa Winhusen, Ph.D. | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synergy Treatment Center | Denver | Colorado | 80219 | United States | ||
| Gateway Community Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21871372 | Background | 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. | |
| 22889694 |
Not provided
Not provided
Not provided
This trial was conducted by the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) between March 2006 and October 2008. Eleven community based treatment programs recruited participants.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Methylphenidate | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Methylphenidate (OROS-MPH) - Placebo | Drug | 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. |
|
| 20 weeks |
| Jacksonville |
| Florida |
| 32211 |
| United States |
| Operation PAR, Inc. | St. Petersburg | Florida | 33709 | United States |
| Mountain Manor Treatment Programs | Baltimore | Maryland | 21229 | United States |
| SSTAR: Stanley Street Treatment & Resources, Inc | Fall River | Massachusetts | 02720-6009 | United States |
| Crittenton | Kansas City | Missouri | 64134 | United States |
| St. Luke's-Roosevelt Hospital, Child and Family Institute | New York | New York | 10025 | United States |
| Rehab After Work-Life Counseling Services | Paoli | Pennsylvania | 19301 | United States |
| Addiction Medicine Services | Pittsburgh | Pennsylvania | 15213 | United States |
| SSTAR of Rhode Island | North Kingstown | Rhode Island | 02852 | United States |
| LRADAC | Columbia | South Carolina | 29205 | United States |
| Mental Health and Retardation of Tarrant County | Fort Worth | Texas | 76107 | United States |
| Derived |
| 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. |
| FG001 | Methylphenidate (Placebo) | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Methylphenidate | 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. |
| BG001 | Methylphenidate (Placebo) | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All randomized participants. | Posted | Mean | Standard Deviation | units on a scale | baseline and 20 weeks |
|
|
| ||||||||||||||||||||||||||||
| 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. | All randomized participants. | Posted | Mean | 95% Confidence Interval | days | 20 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | OROS-MPH Abuse Liability | Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance. | All randomized participants. | Posted | Mean | Standard Deviation | pills | 20 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Substance Use Outcomes | The mean number of negative urine drug screens (UDS). | All randomized participants. | Posted | Mean | Standard Deviation | negative UDS | 20 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methylphenidate | 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. | 4 | 151 | 70 | 151 | ||
| EG001 | Methylphenidate (Placebo) | 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. | 7 | 152 | 64 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aggression | Psychiatric disorders |
| |||
| Psychotic Disorder | Psychiatric disorders |
| |||
| Cyst Rupture | General disorders |
| |||
| Kidney Infection | Infections and infestations |
| |||
| Syncope | Nervous system disorders |
| |||
| Concussion | Injury, poisoning and procedural complications |
| |||
| Asthma | Respiratory, thoracic and mediastinal disorders |
| |||
| Drug Toxicity | Injury, poisoning and procedural complications |
| |||
| Bronchitis | Infections and infestations |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Viral Infection | Infections and infestations |
| |||
| Upper Respiratory Tract Infection | Infections and infestations |
| |||
| Influenza | Infections and infestations |
| |||
| Contusion | Injury, poisoning and procedural complications |
| |||
| Excoriation | Injury, poisoning and procedural complications |
| |||
| Skin Laceration | Injury, poisoning and procedural complications |
| |||
| Joint Sprain | Injury, poisoning and procedural complications |
| |||
| Abdominal Pain Upper | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Toothache | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Aggression | Psychiatric disorders |
| |||
| Nervousness | Psychiatric disorders |
| |||
| Back Pain | Musculoskeletal and connective tissue disorders |
| |||
| Myalgia | Musculoskeletal and connective tissue disorders |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Fatigue | General disorders |
| |||
| Decreased Appetite | Metabolism and nutrition disorders |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paula Riggs; Dr. Theresa Winhusen | Univ of Colorado Denver; Univ of Cincinnati | 303-724-2235; 513-487-7800 | paula.riggs@ucdenver.edu; winhusen@carc.uc.edu |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|