Hyperalgesia in Methadone Patients: Can it be Treated?

NCT00333242 | Unknown Phase 1

• 1 other identifier: R01DA015463-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In the proposed study, we will build upon our previous studies validating and characterizing hyperalgesia in MM samples to explore it's underlying mechanism from a pharmacological perspective. Utilizing a double-blind, placebo-controlled designs, the proposed work will evaluate the ability of dextromethorphan , an N-methyl-D-aspartate (NMDA)-antagonists to diminish or reverse the opioid-induced hyperalgesia complicating the pain states suffered by MM patients. Specifically, in a sample of MM patients, dextromethorphan, theorized to interfere with the development of opioid-induced hyperalgesia will be evaluated for its ability to ameliorate or diminish the opioid-induced hyperalgesia in these patients as reflected by changes on pain threshold and tolerance to both cold-pressor and electrical pain, at peak and trough methadone blood levels. The results of this work will not only provide pharmacologic insight into the mechanisms underlying poor pain tolerance in this at-risk population, but also direction for the medical management of pain complicated by opioid-induced hyperalgesia.

Conditions

Opioid-induced Hyperalgesia

Keywords

Pain; opioid; hyperalgesia; methadone

Outcome Measures

Primary Outcomes (1)

• Pain tolerance

  6 week

Secondary Outcomes (1)

• Pain threshold

  6 week

Interventions

dextromethorphan DRUG

dextromethorphan PO titrated to 480 mg/day x 5 weeks

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be between the ages of 18 and 55 years of age.
• Fulfill DSM-IV criteria for opiate dependence.
• Be compliant in MM treatment and on a stable dose of methadone x 6 weeks.
• Be in good physical health or in the case of a medical condition needing ongoing treatment, be in the care of a physician who is willing to take responsibility for such treatment. The same conditions apply in cases of patients with a psychiatric disorder needing ongoing treatment.
• Be agreeable to and capable of signing an informed consent.

You may not qualify if:

• Have known sensitivity to dextromethorphan, gabapentin or oxycodone.
• Be dependent on alcohol, benzodiazepine or other drugs of abuse (except nicotine).
• Have any acute medical condition that would make participation medically hazardous, (e.g., acute hepatitis, unstable cardiovascular disease, liver or renal disease) or have liver enzyme values (AST or ALT) greater than 5 times normal range.
• Be acutely psychotic, severely depressed and in need of inpatient treatment, or an immediate suicide risk.
• Have a neurological or psychiatric illness (i.e., peripheral neuropathy, schizophrenia, neuropathic pain, Raynaud's disease, urticaria,) that would affect pain responses.
• Be currently taking analgesic medication (opioid or otherwise) for a painful condition on a regular basis.
• Be a nursing or pregnant female. Female of childbearing potential must agree to use a medically acceptable method of birth control, (e.g. oral contraceptives, barrier (diaphragm or condom) with or without spermicide, levonorgestrel implant, intra-uterine progesterone contraceptives system, medroxyprogesterone acetate contraceptive injection) or to complete abstinence. Females who become pregnant during the course of the study will be dropped from the study.
• Have a current or past history of high blood pressure, heart disease, stroke or currently have a pacemaker.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

UCLA School of Nursing

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Pain; Hyperalgesia

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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 Officials

• Margaret A Compton, RN, PhD

  UCLA School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 1, 2006
• First Posted: June 2, 2006
• Study Start: September 1, 2002
• Primary Completion: August 1, 2006
• Last Updated: January 11, 2017

Record last verified: 2008-08

Locations

US (1)