ADHD, Stimulant-Induced Euphoria
Conditions
Keywords
ADHD, Naltrexone, SODAS MPH, Stimulant-Induced Euphoria, Substance Abuse, Adults
Brief summary
The purpose of this study is to a) assess the efficacy of naltrexone in preventing stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We predict that naltrexone will successfully prevent stimulant-induced euphoria without interfering with the ability of stimulants to effectively treat ADHD in adults. This study will be an 8 -week trial with young adults (18-24) with ADHD.
Interventions
DRUGSODAS MPH
Adults with ADHD will receive open-label SODAS MPH
DRUGNaltrexone
Subjects randomized to the active double-blind group will receive Naltrexone HCl
Sponsors
United States Department of Defense
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
Inclusion 1. Male and female outpatients 2. age 18-30 3. diagnosis of ADHD by DSM-IV, per clinical evaluation and confirmed by structured interview 4. likeability response (\> 5) on Question #2 of the DRQ-S after an initial test dose of 60 mg of IR MPH. 5. Baseline ADHD severity of \> 20 on the Adult ADHD Investigator System Report Scale (AISRS) 6. Able to participate in blood draws and to swallow pills. 7. Subjects must be considered reliable reporters, must understand the nature of the study and must sign an informed consent document Exclusion 1. Any current (last month), non-ADHD Axis I psychiatric conditions 2. Ham-D \> 16, BDI \> 19, or Ham-A \> 21 3. Any clinically significant chronic medical condition 4. any cardiovascular disease or hypertension 5. Clinically significant abnormal baseline laboratory values 6. I.Q. \< 80) 7. Organic brain disorders 8. Seizures or tics 9. Pregnant or nursing females 10. Clinically unstable psychiatric conditions (i.e. suicidal behaviors, psychosis) 11. Current or recent (within the past year) substance abuse/dependence 12. patients on other psychotropics 13. Current or prior adequate treatment with MPH 14. known hypersensitivity to methylphenidate 15. Current opioid use (by history and urine screen) or potential need for opioid analgesics during the study 16. acute hepatitis or liver failure (baseline blood tests).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Score on AISRS From Baseline to Week 6 | Baseline and 6 Weeks | 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. |
| Safety | 6 Weeks | Number of adverse events throughout the course of the study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| Placebo Arm 2: Placebo + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH | 16 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Naltrexone | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 16 Participants | 31 Participants |
| Age, Continuous | 25.1 years STANDARD_DEVIATION 2.9 | 24.4 years STANDARD_DEVIATION 3.2 | 24.8 years STANDARD_DEVIATION 3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 14 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 13 Participants | 23 Participants |
| Region of Enrollment United States | 15 participants | 16 participants | 31 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 18 | 16 / 19 |
| serious Total, serious adverse events | 0 / 18 | 0 / 19 |
Outcome results
Primary
Change in Score on AISRS From Baseline to Week 6
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.
Time frame: Baseline and 6 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naltrexone | Change in Score on AISRS From Baseline to Week 6 | -26.7 units on a scale | Standard Deviation 10.1 |
| Placebo | Change in Score on AISRS From Baseline to Week 6 | -29.1 units on a scale | Standard Deviation 10 |
Primary
Safety
Number of adverse events throughout the course of the study
Time frame: 6 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Naltrexone | Safety | 6.73 adverse events | Standard Deviation 4.7 |
| Placebo | Safety | 4.75 adverse events | Standard Deviation 3.4 |