Trial Outcomes & Findings for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD) (NCT NCT00264797)
NCT ID: NCT00264797
Last Updated: 2013-06-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
303 participants
Primary outcome timeframe
baseline and 20 weeks
Results posted on
2013-06-07
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
152
|
|
Overall Study
COMPLETED
|
118
|
109
|
|
Overall Study
NOT COMPLETED
|
33
|
43
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
11
|
|
Overall Study
Lost to Follow-up
|
9
|
17
|
|
Overall Study
Moved from area
|
3
|
1
|
|
Overall Study
Practical Problems
|
2
|
3
|
|
Overall Study
Incarceration
|
4
|
5
|
|
Overall Study
Pressure/advice from Outsiders
|
1
|
1
|
|
Overall Study
Feels treatment not necessary, not worki
|
0
|
1
|
|
Overall Study
Other
|
3
|
4
|
Baseline Characteristics
Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
Baseline characteristics by cohort
| Measure |
Methylphenidate
n=151 Participants
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)
n=152 Participants
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.
|
Total
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
151 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
303 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
|
16.4 years
STANDARD_DEVIATION 1.3 • n=99 Participants
|
16.6 years
STANDARD_DEVIATION 1.2 • n=107 Participants
|
16.5 years
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
239 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
151 participants
n=99 Participants
|
152 participants
n=107 Participants
|
303 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 20 weeksPopulation: All randomized participants.
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.
Outcome measures
| Measure |
Methylphenidate
n=151 Participants
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)
n=152 Participants
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.
|
|---|---|---|
|
ADHD Severity
|
-20.6 units on a scale
Standard Deviation 11.1
|
-21.8 units on a scale
Standard Deviation 11.9
|
PRIMARY outcome
Timeframe: 20 weeksPopulation: All randomized participants.
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.
Outcome measures
| Measure |
Methylphenidate
n=151 Participants
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)
n=152 Participants
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.
|
|---|---|---|
|
Substance Use
|
-5.7 days
95% Confidence Interval 0.8 • Interval -7.4 to -4.0
|
-5.2 days
95% Confidence Interval 0.9 • Interval -7.0 to -3.5
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: All randomized participants.
Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance.
Outcome measures
| Measure |
Methylphenidate
n=151 Participants
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)
n=152 Participants
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.
|
|---|---|---|
|
OROS-MPH Abuse Liability
|
15.4 pills
Standard Deviation 18.7
|
9.7 pills
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: All randomized participants.
The mean number of negative urine drug screens (UDS).
Outcome measures
| Measure |
Methylphenidate
n=151 Participants
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)
n=152 Participants
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.
|
|---|---|---|
|
Substance Use Outcomes
|
3.8 negative UDS
Standard Deviation 4.9
|
2.8 negative UDS
Standard Deviation 4.2
|
Adverse Events
Methylphenidate
Serious events: 4 serious events
Other events: 70 other events
Deaths: 0 deaths
Methylphenidate (Placebo)
Serious events: 7 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methylphenidate
n=151 participants at risk
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)
n=152 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Aggression
|
0.66%
1/151 • Number of events 1
|
1.3%
2/152 • Number of events 2
|
|
Psychiatric disorders
Psychotic Disorder
|
0.66%
1/151 • Number of events 1
|
0.00%
0/152
|
|
General disorders
Cyst Rupture
|
0.66%
1/151 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Kidney Infection
|
0.66%
1/151 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Syncope
|
0.00%
0/151
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/151
|
0.66%
1/152 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/151
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Drug Toxicity
|
0.00%
0/151
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/151
|
0.66%
1/152 • Number of events 1
|
Other adverse events
| Measure |
Methylphenidate
n=151 participants at risk
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)
n=152 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Nervousness
|
7.9%
12/151 • Number of events 15
|
2.0%
3/152 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.9%
12/151 • Number of events 16
|
9.9%
15/152 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
6/151 • Number of events 7
|
6.6%
10/152 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
6/151 • Number of events 8
|
5.9%
9/152 • Number of events 10
|
|
General disorders
Fatigue
|
2.6%
4/151 • Number of events 4
|
7.2%
11/152 • Number of events 11
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
16.6%
25/151 • Number of events 33
|
5.9%
9/152 • Number of events 11
|
|
Nervous system disorders
Headache
|
46.4%
70/151 • Number of events 141
|
42.1%
64/152 • Number of events 116
|
|
Infections and infestations
Nasopharyngitis
|
15.2%
23/151 • Number of events 31
|
15.1%
23/152 • Number of events 27
|
|
Infections and infestations
Viral Infection
|
11.9%
18/151 • Number of events 27
|
9.2%
14/152 • Number of events 24
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.9%
12/151 • Number of events 13
|
8.6%
13/152 • Number of events 14
|
|
Infections and infestations
Influenza
|
3.3%
5/151 • Number of events 6
|
7.2%
11/152 • Number of events 14
|
|
Injury, poisoning and procedural complications
Contusion
|
13.2%
20/151 • Number of events 25
|
7.9%
12/152 • Number of events 14
|
|
Injury, poisoning and procedural complications
Excoriation
|
9.3%
14/151 • Number of events 14
|
2.6%
4/152 • Number of events 6
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
3.3%
5/151 • Number of events 6
|
7.9%
12/152 • Number of events 12
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
4.6%
7/151 • Number of events 8
|
5.9%
9/152 • Number of events 10
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
16.6%
25/151 • Number of events 35
|
17.1%
26/152 • Number of events 35
|
|
Gastrointestinal disorders
Vomiting
|
10.6%
16/151 • Number of events 18
|
9.2%
14/152 • Number of events 16
|
|
Gastrointestinal disorders
Toothache
|
6.6%
10/151 • Number of events 11
|
6.6%
10/152 • Number of events 10
|
|
Gastrointestinal disorders
Nausea
|
5.3%
8/151 • Number of events 8
|
5.9%
9/152 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
15.2%
23/151 • Number of events 27
|
13.8%
21/152 • Number of events 25
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.6%
16/151 • Number of events 18
|
12.5%
19/152 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
10.6%
16/151 • Number of events 18
|
9.9%
15/152 • Number of events 18
|
|
Psychiatric disorders
Insomnia
|
13.9%
21/151 • Number of events 33
|
11.8%
18/152 • Number of events 21
|
|
Psychiatric disorders
Aggression
|
4.0%
6/151 • Number of events 7
|
7.9%
12/152 • Number of events 16
|
Additional Information
Dr. Paula Riggs; Dr. Theresa Winhusen
Univ of Colorado Denver; Univ of Cincinnati
Phone: 303-724-2235; 513-487-7800
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place