Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

ADHD Clinical Trial

Official title:

Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673594
• Other study ID #: 2012-P-000918
• Status: Completed
• Phase: Phase 4
• First received: June 21, 2012
• Last updated: February 1, 2016
• Start date: September 2012
• Est. completion date: June 2015

Study information

• Verified date: February 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Stimulant-Induced Euphoria

Intervention

Drug:
• SODAS MPH
Adults with ADHD will receive open-label SODAS MPH
• Naltrexone
Subjects randomized to the "active" double-blind group will receive Naltrexone HCl

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Efficacy (positive, or 'liking' response to stimulant medication) will be assessed by the change in the Drug Rating Questionnaire - Subject (DRQ-S).	6 Weeks	No