Dextromethorphan, Gabapentin, and Oxycodone to Treat Opioid-Induced Hyperalgesia

January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)

Hyperalgesia in Methadone Patients: Can it be Treated?

Individuals who reduce or stop use of opioid medications are at risk for developing hyperalgesia, which is an increased sensitivity to pain. This study will compare the effectiveness of dextromethorphan, gabapentin, and oxycodone at reducing hyperalgesia in individuals addicted to opioids who are concurrently receiving methadone treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Opioid medications are frequently used for the treatment of moderate to severe pain; however, individuals who use opioids have a high risk of becoming addicted. Opioid users who abruptly stop using opioid drugs may experience withdrawal symptoms, including drug craving, sweating, sleep disruption, nausea, irritability, and pain. Hyperalgesia, a severe and excessive sensitivity to pain, is a serious condition that may also occur when opioid use is reduced or discontinued. Opioid medications affect both the pain inhibitory and facilitatory systems, meaning that while they are effective at treating pain in many individuals, they also have the ability to intensify pain and cause hyperalgesia in some opioid users. Three medications, dextromethorphan, gabapentin, and oxycodone, may alleviate the symptoms of hyperalgesia and lessen an individual's sensitivity to pain. Further research is needed to confirm the benefits of these medications for opioid addicts. The purpose of this study is to compare the effectiveness of dextromethorphan, gabapentin, and oxycodone at reducing opioid-induced hyperalgesia in methadone-maintained opioid addicts.

This study will involve three separate experiments. Participants in Experiment 1 will be randomly assigned to receive either dextromethorphan or placebo; in Experiment 2, participants will be randomly assigned to receive either gabapentin or placebo; and in Experiment 3, participants will be randomly assigned to receive either oxycodone or placebo. Each experiment will last 5 weeks. All 3 experiments will begin with a screening session. Potential participants will undergo a physical exam and an electrocardiogram. Blood and urine will be collected for laboratory tests and drug screening. Each individual's medical and drug history will be reviewed and psychological and opiate withdrawal symptoms will be assessed. Individuals who complete the screening and meet all study requirements will be permitted to continue in the study.

All participants will be maintained on methadone throughout the study. Participants will also receive either the study medication (dextromethorphan, gabapentin, or oxycodone) or placebo four times per day beginning on Day 5. Study visits will take place once a week. At each visit, medications for the previous week will be accounted for and medications for the following week will be dispensed. Questionnaires and self-reports will be completed to assess depression levels and drug use. Urine tests will be used to screen for the presence of drugs and alcohol. During the study, participants will take part in four pain testing sessions to measure pain threshold and tolerance; two sessions will take place during Week 1 and another two sessions will occur during Week 5. The pain testing sessions will include a cold pressor (CP) test and an electrical stimulation (ES) procedure. The CP test will involve placing an arm in ice water for a short period of time; the ES procedure will involve stimulating muscle nerve endings via electrodes placed on the skin. Immediately after the CP and ES sessions, blood will be drawn for laboratory testing. Participants will again complete questionnaires and self-reports, and urine samples will be collected. Gift cards will be offered as an incentive for attending study visits and having negative drug tests.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • University of California, Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be between the ages of 18 and 55 years of age.
  • Meets DSM-IV diagnostic criteria for opioid dependence
  • Taking a stable dose of methadone for 6 weeks prior to study entry and is compliant in methadone maintenance treatment
  • Is in good physical health or under a physician's care if a medical condition requires ongoing treatment

Exclusion Criteria:

  • Known sensitivity to dextromethorphan, gabapentin, or oxycodone
  • Currently dependent on alcohol, benzodiazepine, or any drug (other than nicotine)
  • Currently in an acutely psychotic, severely depressed state and in need of inpatient treatment
  • Immediate suicide risk
  • Neurological or psychiatric illness (e.g., peripheral neuropathy, schizophrenia, neuropathic pain, Raynaud's disease, or urticaria)
  • Acute medical condition that would make study participation medically dangerous (e.g., acute hepatitis, unstable cardiovascular disease, liver disease, or kidney disease)
  • Liver enzyme values five times greater than normal
  • Currently taking analgesic medication for a painful condition on a regular basis
  • Current or past history of high blood pressure, heart disease, or stroke
  • Currently using a pacemaker
  • Pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain response (measured after each pain testing session on Days 1, 4, 36, and 39)
Time Frame: 6 week
6 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Margaret Compton, PhD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-15463-1
  • DPMC (Other Identifier: NIDA)
  • R01-15463-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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