Clinical trial NCT01673594: Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
Official title: Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ADHD
Stimulant-Induced Euphoria
Keywords: ADHD
Naltrexone
SODAS MPH
Stimulant-Induced Euphoria
Substance Abuse
Adults
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2012-08-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Change in Score on AISRS From Baseline to Week 6
timeFrame: Baseline and 6 Weeks
measure: Safety
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Thomas J Spencer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.