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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peggy Compton, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01210079
First received: September 27, 2010
Last updated: March 11, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Opioid-Induced Hyperalgesia
Drug: Gabapentin;
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change in Pain Threshold Time From Baseline to Week 5 [ Time Frame: baseline, 5 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 26
Study Start Date: September 2002
Study Completion Date: May 2010
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gabapentin Drug: Gabapentin;
Gabapentin titrated to daily dose of 2400mg PO over 1 week with established dose taken daily for 5 weeks.
Placebo Comparator: Placebo Drug: Placebo
Placebo titrated over 1 week with established dose taken daily for 5 weeks.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Potential participants must:

  1. Be between the ages of 21 and 55 years of age.
  2. DSM-IVR diagnosis of prescription opioid abuse or dependence disorder
  3. Be compliant in methadone treatment
  4. On a stable dose of methadone at least 6 weeks.
  5. Have provided random urine samples absent of any non-prescribed drugs of abuse x 2 months
  6. 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.
  7. Be agreeable to and capable of signing an informed consent.

Exclusion Criteria:

Potential participants must not:

  1. Have known sensitivity to gabapentin.
  2. Be substance dependent on alcohol, benzodiazepine, methamphetamine, cocaine or other drugs of abuse (except nicotine).
  3. 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.
  4. Be acutely psychotic, severely depressed and in need of inpatient treatment, or an immediate suicide risk.
  5. Have a neurological or psychiatric illness (i.e., schizophrenia, Raynaud's disease, urticaria, stroke) that would affect pain responses.
  6. Be currently taking opioid analgesic medication for a painful condition on a regular basis.
  7. 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.
  8. Have a current or past history of high blood pressure, heart disease, stroke or currently have a pacemaker.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210079

Locations
United States, California
UCLA School of Nursing
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Margaret (Peggy) A Compton, RN, PhD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Peggy Compton, Professor, Associate Dean for Academic Affairs, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01210079     History of Changes
Other Study ID Numbers: R01 DA 05463
Study First Received: September 27, 2010
Results First Received: December 5, 2011
Last Updated: March 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
opioid-induced hyperalgesia
methadone
gabapentin
opioid addiction

Additional relevant MeSH terms:
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methadone
Gabapentin
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 23, 2014