Trial Outcomes & Findings for Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence (NCT NCT00553319)
NCT ID: NCT00553319
Last Updated: 2019-04-24
Results Overview
Each week after randomization was scored dichotomously as cocaine positive or negative. Cocaine use was positive if any urine or self-report was positive. Cocaine use was negative if all urines (BE \<300 ng/ml) and all self-report were negative. Weeks with no urine or no self-report were designated missing.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
139 participants
Primary outcome timeframe
weekly for 14 weeks of trial or for length of participation
Results posted on
2019-04-24
Participant Flow
Study consisted of a one week single blind placebo run-in prior to group assignment. 139 participants were enrolled and 126 were randomized following the placebo run-up
Participant milestones
| Measure |
Placebo
Placebo
Placebo: Placebo group
|
Adderall-XR 60 mg
Adderall-XR 60 mg
Adderall-XR: Adderall-XR 60mg/day
|
Adderall-XR 80 mg
Adderall-XR 80 mg
Adderall-XR: Adderall-XR 80mg/day
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
40
|
43
|
|
Overall Study
COMPLETED
|
29
|
30
|
34
|
|
Overall Study
NOT COMPLETED
|
14
|
10
|
9
|
Reasons for withdrawal
| Measure |
Placebo
Placebo
Placebo: Placebo group
|
Adderall-XR 60 mg
Adderall-XR 60 mg
Adderall-XR: Adderall-XR 60mg/day
|
Adderall-XR 80 mg
Adderall-XR 80 mg
Adderall-XR: Adderall-XR 80mg/day
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
9
|
5
|
|
Overall Study
wanted treatment elsewhere
|
2
|
1
|
1
|
|
Overall Study
non-compliance
|
0
|
0
|
2
|
|
Overall Study
incarceration
|
1
|
0
|
0
|
|
Overall Study
moved
|
1
|
0
|
1
|
Baseline Characteristics
Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence
Baseline characteristics by cohort
| Measure |
Placebo
n=43 Participants
Placebo
Placebo: Placebo group
|
Adderall-XR 60 mg
n=40 Participants
Adderall-XR 60 mg
Adderall-XR: Adderall-XR 60mg/day
|
Adderall-XR 80 mg
n=43 Participants
Adderall-XR 80 mg
Adderall-XR: Adderall-XR 80mg/day
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.3 YEARS
STANDARD_DEVIATION 7.4 • n=5 Participants
|
43.9 YEARS
STANDARD_DEVIATION 7.5 • n=7 Participants
|
38.4 YEARS
STANDARD_DEVIATION 8.6 • n=5 Participants
|
40.4 YEARS
STANDARD_DEVIATION 8.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Days of cocaine use (prior 28 days)
|
11.3 DAYS
STANDARD_DEVIATION 7.5 • n=5 Participants
|
12.4 DAYS
STANDARD_DEVIATION 7.8 • n=7 Participants
|
11.3 DAYS
STANDARD_DEVIATION 7.0 • n=5 Participants
|
11.7 DAYS
STANDARD_DEVIATION 7.4 • n=4 Participants
|
PRIMARY outcome
Timeframe: weekly for 14 weeks of trial or for length of participationEach week after randomization was scored dichotomously as cocaine positive or negative. Cocaine use was positive if any urine or self-report was positive. Cocaine use was negative if all urines (BE \<300 ng/ml) and all self-report were negative. Weeks with no urine or no self-report were designated missing.
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo
Placebo: Placebo group
|
Adderall-XR 60 mg
n=40 Participants
Adderall-XR 60 mg
Adderall-XR: Adderall-XR 60mg/day
|
Adderall-XR 80 mg
n=43 Participants
Adderall-XR 80 mg
Adderall-XR: Adderall-XR 80mg/day
|
|---|---|---|---|
|
Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use
|
7 percentage of participants
|
18 percentage of participants
|
30 percentage of participants
|
PRIMARY outcome
Timeframe: measured once per week for 14 weeks or length of study participationThe proportion of subjects exhibiting \>30% reduction of AISRS score at last enrollment week compared to week 0
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo
Placebo: Placebo group
|
Adderall-XR 60 mg
n=40 Participants
Adderall-XR 60 mg
Adderall-XR: Adderall-XR 60mg/day
|
Adderall-XR 80 mg
n=43 Participants
Adderall-XR 80 mg
Adderall-XR: Adderall-XR 80mg/day
|
|---|---|---|---|
|
ADHD Symptoms Based on ADHD Rating Scale
|
17 participants
|
30 participants
|
25 participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Adderall-XR 60 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Adderall-XR 80 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=43 participants at risk
Placebo
Placebo: Placebo group
|
Adderall-XR 60 mg
n=40 participants at risk
Adderall-XR 60 mg
Adderall-XR: Adderall-XR 60mg/day
|
Adderall-XR 80 mg
n=43 participants at risk
Adderall-XR 80 mg
Adderall-XR: Adderall-XR 80mg/day
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
2.3%
1/43 • Number of events 1 • During 14 weeks of trial or length of study participation
|
0.00%
0/40 • During 14 weeks of trial or length of study participation
|
0.00%
0/43 • During 14 weeks of trial or length of study participation
|
|
General disorders
rape
|
2.3%
1/43 • Number of events 1 • During 14 weeks of trial or length of study participation
|
0.00%
0/40 • During 14 weeks of trial or length of study participation
|
0.00%
0/43 • During 14 weeks of trial or length of study participation
|
Other adverse events
| Measure |
Placebo
n=43 participants at risk
Placebo
Placebo: Placebo group
|
Adderall-XR 60 mg
n=40 participants at risk
Adderall-XR 60 mg
Adderall-XR: Adderall-XR 60mg/day
|
Adderall-XR 80 mg
n=43 participants at risk
Adderall-XR 80 mg
Adderall-XR: Adderall-XR 80mg/day
|
|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
7.0%
3/43 • Number of events 3 • During 14 weeks of trial or length of study participation
|
15.0%
6/40 • Number of events 6 • During 14 weeks of trial or length of study participation
|
16.3%
7/43 • Number of events 7 • During 14 weeks of trial or length of study participation
|
|
General disorders
Insomnia
|
2.3%
1/43 • Number of events 1 • During 14 weeks of trial or length of study participation
|
12.5%
5/40 • Number of events 5 • During 14 weeks of trial or length of study participation
|
16.3%
7/43 • Number of events 7 • During 14 weeks of trial or length of study participation
|
|
General disorders
Dry Mouth
|
0.00%
0/43 • During 14 weeks of trial or length of study participation
|
17.5%
7/40 • Number of events 7 • During 14 weeks of trial or length of study participation
|
11.6%
5/43 • Number of events 5 • During 14 weeks of trial or length of study participation
|
|
General disorders
Decreased Appetite
|
2.3%
1/43 • Number of events 1 • During 14 weeks of trial or length of study participation
|
12.5%
5/40 • Number of events 5 • During 14 weeks of trial or length of study participation
|
9.3%
4/43 • Number of events 4 • During 14 weeks of trial or length of study participation
|
|
General disorders
Fidgety/Jittery
|
2.3%
1/43 • Number of events 1 • During 14 weeks of trial or length of study participation
|
5.0%
2/40 • Number of events 2 • During 14 weeks of trial or length of study participation
|
7.0%
3/43 • Number of events 3 • During 14 weeks of trial or length of study participation
|
|
General disorders
headache
|
7.0%
3/43 • Number of events 3 • During 14 weeks of trial or length of study participation
|
5.0%
2/40 • Number of events 2 • During 14 weeks of trial or length of study participation
|
0.00%
0/43 • During 14 weeks of trial or length of study participation
|
|
Cardiac disorders
Racing heart
|
2.3%
1/43 • Number of events 1 • During 14 weeks of trial or length of study participation
|
5.0%
2/40 • Number of events 2 • During 14 weeks of trial or length of study participation
|
4.7%
2/43 • Number of events 2 • During 14 weeks of trial or length of study participation
|
|
General disorders
Fatigue
|
0.00%
0/43 • During 14 weeks of trial or length of study participation
|
5.0%
2/40 • Number of events 2 • During 14 weeks of trial or length of study participation
|
4.7%
2/43 • Number of events 2 • During 14 weeks of trial or length of study participation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place