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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone | Experimental | Arm 1: Naltrexone + SODAS MPH |
|
| Placebo | Placebo Comparator | Arm 2: Placebo + SODAS MPH |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SODAS MPH | Drug | Adults with ADHD will receive open-label SODAS MPH |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 Weeks |
| Safety | Number of adverse events throughout the course of the study | 6 Weeks |
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Inclusion
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Thomas J Spencer, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29617066 | Derived | Spencer TJ, Bhide P, Zhu J, Faraone SV, Fitzgerald M, Yule AM, Uchida M, Spencer AE, Hall AM, Koster AJ, Feinberg L, Kassabian S, Storch B, Biederman J. The Mixed Opioid Receptor Antagonist Naltrexone Mitigates Stimulant-Induced Euphoria: A Double-Blind, Placebo-Controlled Trial of Naltrexone. J Clin Psychiatry. 2018 Mar/Apr;79(2):17m11609. doi: 10.4088/JCP.17m11609. | |
| 28640990 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Arm 2: Placebo + SODAS MPH SODAS MPH: Adults with ADHD will receive open-label SODAS MPH |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics are reported for subjects who made it to week 3 of the trial and were included in analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| 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 |
| 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 Weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold/Infection/Allergy | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Regulatory Coordinator | Massachusetts General Hospital | 617-726-4651 | apulli@mgh.harvard.edu |
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| 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 |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Naltrexone | Drug | Subjects randomized to the "active" double-blind group will receive Naltrexone HCl |
|
|
| Spencer TJ, Bhide P, Zhu J, Faraone SV, Fitzgerald M, Yule AM, Uchida M, Spencer AE, Hall AM, Koster AJ, Biederman J. Opiate Antagonists Do Not Interfere With the Clinical Benefits of Stimulants in ADHD: A Double-Blind, Placebo-Controlled Trial of the Mixed Opioid Receptor Antagonist Naltrexone. J Clin Psychiatry. 2018 Jan/Feb;79(1):16m11012. doi: 10.4088/JCP.16m11012. |
| Physician Decision |
|
| Withdrawal by Subject |
|
Arm 2: Placebo + SODAS MPH
SODAS MPH: Adults with ADHD will receive open-label SODAS MPH
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Arm 2: Placebo + SODAS MPH SODAS MPH: Adults with ADHD will receive open-label SODAS MPH |
|
|
| Primary | Safety | Number of adverse events throughout the course of the study | Posted | Mean | Standard Deviation | adverse events | 6 Weeks |
|
|
|
| 0 |
| 18 |
| 18 |
| 18 |
| EG001 | Placebo | Arm 2: Placebo + SODAS MPH SODAS MPH: Adults with ADHD will receive open-label SODAS MPH | 0 | 19 | 16 | 19 |
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Nausea/Vomit/Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Insomnia | Nervous system disorders | Systematic Assessment |
|
| Sedation | Nervous system disorders | Systematic Assessment |
|
| Decreased Energy | Psychiatric disorders | Systematic Assessment |
|
| Increased Energy | Psychiatric disorders | Systematic Assessment |
|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
|
| Tense/Jittery | Psychiatric disorders | Systematic Assessment |
|
| Agitated/irritable | Psychiatric disorders | Systematic Assessment |
|
| Sad/Down | Psychiatric disorders | Systematic Assessment |
|
| Anxious/Worried | Psychiatric disorders | Systematic Assessment |
|
| Autonomic: Drool/Sweat | General disorders | Systematic Assessment |
|
| Mucosal Dryness | General disorders | Systematic Assessment |
|
| DizzyLightheaded | Nervous system disorders | Systematic Assessment |
|
| Extra Pyramidal Symptoms | Nervous system disorders | Systematic Assessment |
|
| Neurological | Nervous system disorders | Systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dermatological | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pressure | General disorders | Systematic Assessment |
|
| Feels Warm | General disorders | Systematic Assessment |
|
| Unable to Feel Emotions | Psychiatric disorders | Systematic Assessment |
|
| Tingly Feeling in Head and Chest | General disorders | Systematic Assessment |
|
| Menstrual Cramps | Reproductive system and breast disorders | Systematic Assessment |
|
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |