Trial of Naltrexone and Dextromethorphan for Gulf War Illness

NCT02206490 | Completed Phase 2

• 1 other identifier: 090562
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Veterans of the 1991 Gulf War who developed Gulf War Illness are being studied. Treatments with FDA approved generic drugs are being administered to see if they help with the symptoms of Gulf War Illness, such as chronic fatigue; difficulty with memory, concentration, and thinking; widespread chronic pain; and autonimic dysfunction. Drugs to be tested are dextromethorphan and naltrexone.

Conditions

Gulf War Illness

Keywords

Gulf War Illness; treatment; dextromethorphan; naltrexone

Outcome Measures

Primary Outcomes (1)

• Symptoms Scores

  Symptoms of Gulf War Illness will be scored by participants using a ten center meter scale. Scores will be collected at the end of 12 weeks/16 weeks/28weeks

  28 weeks approximately

Secondary Outcomes (2)

• SF-36

  28 weeks approximately

• Connors Continuous Performance Test

  28 weeks approximately

Study Arms (4)

Naltrexone Study Drug

ACTIVE COMPARATOR

Subjects will take naltrexone 4.5 mg daily for three months.

Drug: naltrexone

Naltrexone placebo

PLACEBO COMPARATOR

Subjects will take a 3 month course of a placebo pill identical in appearance to the naltrexone study drug.

Drug: naltrexone

dextromethrophan study drug

ACTIVE COMPARATOR

subjects will take a sustained release dextromethorphan pill twice a day.

Drug: Dextromethorphan

dextromethoprhan placebo

PLACEBO COMPARATOR

Subjects will take a 3 month course of a placebo pill identical in appearance to the dextromethorphan study drug.

Drug: Dextromethorphan

Interventions

naltrexone DRUG

Randomized controlled trial of naltrexone for Gulf War Illness.

Naltrexone Study Drug; Naltrexone placebo

Dextromethorphan DRUG

Randomized controlled trial of dextromethorphan for Gulf War Illness

dextromethoprhan placebo; dextromethrophan study drug

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Served in the Gulf War and developed the symptoms of Gulf War Illness as described by the modified Kansas Case Definition

You may not qualify if:

• Pregnant women, nursing mothers, individuals requiring medications that have drug interactions with dextromethorphan or naltrexone, cancer not in remission, chronic infectious disease, liver disease, lupus, multiple sclerosis, stroke, under current treatment for schizophrenia, bipolar disorder/manic depression, and depression.
• Those with a history of current illicit drug use will be excluded. Individuals who have had recent surgery will not be enrolled until they have completely recovered from the surgery.
• Subjects participating in other clinical trials will be excluded.
• Those enrolled recently in a clinical trial will be enrolled after a washout period of one month.

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

Brody School of Medicine a East Carolina Univesity

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Interventions

Naltrexone; Dextromethorphan

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: August 1, 2014
• Study Start: January 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

US (1)