Trial Outcomes & Findings for Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist (NCT NCT01673594)
NCT ID: NCT01673594
Last Updated: 2016-11-30
Results Overview
The Adult ADHD Investigator System Report Scale (AISRS) is an 18-item, DSM-IV symptom Likert scale that measures ADHD symptoms in adults. Each of the individual symptoms of ADHD is rated from 0 to 3 on a scale of severity (3 being more severe symptoms). Total scores range from 0 to 54; higher scores indicate greater symptom severity. Change was calculated as value at baseline minus value at 6 weeks.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
Baseline and 6 Weeks
Results posted on
2016-11-30
Participant Flow
Participant milestones
| Measure |
Naltrexone
Arm 1: Naltrexone + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
Naltrexone: Subjects randomized to the "active" double-blind group will receive Naltrexone HCl
|
Placebo
Arm 2: Placebo + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Naltrexone
Arm 1: Naltrexone + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
Naltrexone: Subjects randomized to the "active" double-blind group will receive Naltrexone HCl
|
Placebo
Arm 2: Placebo + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
Baseline characteristics by cohort
| Measure |
Naltrexone
n=15 Participants
Arm 1: Naltrexone + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
Naltrexone: Subjects randomized to the "active" double-blind group will receive Naltrexone HCl
|
Placebo
n=16 Participants
Arm 2: Placebo + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.1 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
24.4 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
24.8 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 WeeksThe Adult ADHD Investigator System Report Scale (AISRS) is an 18-item, DSM-IV symptom Likert scale that measures ADHD symptoms in adults. Each of the individual symptoms of ADHD is rated from 0 to 3 on a scale of severity (3 being more severe symptoms). Total scores range from 0 to 54; higher scores indicate greater symptom severity. Change was calculated as value at baseline minus value at 6 weeks.
Outcome measures
| Measure |
Naltrexone
n=12 Participants
Arm 1: Naltrexone + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
Naltrexone: Subjects randomized to the "active" double-blind group will receive Naltrexone HCl
|
Placebo
n=13 Participants
Arm 2: Placebo + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
|
|---|---|---|
|
Change in Score on AISRS From Baseline to Week 6
|
-26.7 units on a scale
Standard Deviation 10.1
|
-29.1 units on a scale
Standard Deviation 10.0
|
PRIMARY outcome
Timeframe: 6 WeeksNumber of adverse events throughout the course of the study
Outcome measures
| Measure |
Naltrexone
n=15 Participants
Arm 1: Naltrexone + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
Naltrexone: Subjects randomized to the "active" double-blind group will receive Naltrexone HCl
|
Placebo
n=16 Participants
Arm 2: Placebo + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
|
|---|---|---|
|
Safety
|
6.73 adverse events
Standard Deviation 4.7
|
4.75 adverse events
Standard Deviation 3.4
|
Adverse Events
Naltrexone
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naltrexone
n=18 participants at risk
Arm 1: Naltrexone + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
Naltrexone: Subjects randomized to the "active" double-blind group will receive Naltrexone HCl
|
Placebo
n=19 participants at risk
Arm 2: Placebo + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
|
|---|---|---|
|
General disorders
Cold/Infection/Allergy
|
11.1%
2/18 • Number of events 2 • 6 weeks
|
21.1%
4/19 • Number of events 5 • 6 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.8%
5/18 • Number of events 13 • 6 weeks
|
5.3%
1/19 • Number of events 2 • 6 weeks
|
|
Nervous system disorders
Headache
|
44.4%
8/18 • Number of events 20 • 6 weeks
|
36.8%
7/19 • Number of events 16 • 6 weeks
|
|
Gastrointestinal disorders
Nausea/Vomit/Diarrhea
|
66.7%
12/18 • Number of events 19 • 6 weeks
|
42.1%
8/19 • Number of events 9 • 6 weeks
|
|
Nervous system disorders
Insomnia
|
44.4%
8/18 • Number of events 14 • 6 weeks
|
36.8%
7/19 • Number of events 13 • 6 weeks
|
|
Nervous system disorders
Sedation
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Psychiatric disorders
Decreased Energy
|
22.2%
4/18 • Number of events 4 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Psychiatric disorders
Increased Energy
|
11.1%
2/18 • Number of events 2 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Cardiac disorders
Cardiovascular
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
21.1%
4/19 • Number of events 5 • 6 weeks
|
|
Psychiatric disorders
Tense/Jittery
|
27.8%
5/18 • Number of events 7 • 6 weeks
|
15.8%
3/19 • Number of events 5 • 6 weeks
|
|
Psychiatric disorders
Agitated/irritable
|
22.2%
4/18 • Number of events 4 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Psychiatric disorders
Sad/Down
|
16.7%
3/18 • Number of events 5 • 6 weeks
|
10.5%
2/19 • Number of events 2 • 6 weeks
|
|
Psychiatric disorders
Anxious/Worried
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
15.8%
3/19 • Number of events 3 • 6 weeks
|
|
General disorders
Autonomic: Drool/Sweat
|
11.1%
2/18 • Number of events 2 • 6 weeks
|
10.5%
2/19 • Number of events 3 • 6 weeks
|
|
General disorders
Mucosal Dryness
|
11.1%
2/18 • Number of events 4 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Nervous system disorders
DizzyLightheaded
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Nervous system disorders
Extra Pyramidal Symptoms
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Nervous system disorders
Neurological
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
16.7%
3/18 • Number of events 5 • 6 weeks
|
21.1%
4/19 • Number of events 5 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
General disorders
Pressure
|
5.6%
1/18 • Number of events 1 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
General disorders
Feels Warm
|
5.6%
1/18 • Number of events 2 • 6 weeks
|
0.00%
0/19 • 6 weeks
|
|
Psychiatric disorders
Unable to Feel Emotions
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
General disorders
Tingly Feeling in Head and Chest
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
|
Reproductive system and breast disorders
Menstrual Cramps
|
0.00%
0/18 • 6 weeks
|
5.3%
1/19 • Number of events 1 • 6 weeks
|
Additional Information
Research Regulatory Coordinator
Massachusetts General Hospital
Phone: 617-726-4651
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place