Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Stimulant-Induced Euphoria; ADHD

Treatments: Drug: Naltrexone; Drug: SODAS MPH

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01673594

2012-P-000918

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 2 patient groups, including a placebo group

Naltrexone

Experimental group

Description:

Arm 1: Naltrexone + SODAS MPH

Treatment:

Drug: SODAS MPH

Drug: Naltrexone

Placebo

Placebo Comparator group

Description:

Arm 2: Placebo + SODAS MPH

Treatment:

Drug: SODAS MPH