Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?

Utilizing a double-blind, placebo-controlled design, the proposed work will evaluate the ability of an adjuvant anticonvulsant analgesic to diminish or reverse the opioid-induced hyperalgesia complicating the pain states suffered by Methadone-Maintained (MM) patients. Specifically, in a sample of MM patients, gabapentin, which has proven efficacy in treating neuropathic pain 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 through 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.

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Key information

Conditions

Opioid-induced Hyperalgesia Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCLA School of Nursing

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Potential participants must:

Be between the ages of 21 and 55 years of age.
DSM-IVR diagnosis of prescription opioid abuse or dependence disorder
Be compliant in methadone treatment
On a stable dose of methadone at least 6 weeks.
Have provided random urine samples absent of any non-prescribed drugs of abuse x 2 months
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.

Exclusion criteria

Potential participants must not:

Have known sensitivity to gabapentin.
Be substance dependent on alcohol, benzodiazepine, methamphetamine, cocaine 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., schizophrenia, Raynaud's disease, urticaria, stroke) that would affect pain responses.
Be currently taking opioid analgesic medication 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.

Treatment and study plan

Gabapentin;

Drug

Gabapentin titrated to daily dose of 2400mg PO over 1 week with established dose taken daily for 5 weeks.

Placebo

Drug

Placebo titrated over 1 week with established dose taken daily for 5 weeks.

Primary outcomes

Change in Pain Threshold Time From Baseline to Week 5

Time frame: baseline, 5 weeks

Change in pain threshold time from baseline (pre-gabapentin) to week 5 (post gabapentin)measured during cold pressor task administered at peak methadone blood levels. Pain threshold time is the amount of time that passes before pain is detected after administration of the cold pressor.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Important dates

Study start: 2002
Primary completion: 2008
Study completion: 2010
First posted: Sep 28, 2010
Registry last updated: Apr 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed