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

September 27, 2010
March 11, 2012
September 2002
March 2008   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT01210079 on ClinicalTrials.gov Archive Site
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Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?
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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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Opioid-Induced Hyperalgesia
  • Drug: Gabapentin;
    Gabapentin titrated to daily dose of 2400mg PO over 1 week with established dose taken daily for 5 weeks.
  • Drug: Placebo
    Placebo titrated over 1 week with established dose taken daily for 5 weeks.
  • Experimental: Gabapentin
    Intervention: Drug: Gabapentin;
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
May 2010
March 2008   (final data collection date for primary outcome measure)

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.
Both
21 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01210079
R01 DA 05463
No
Peggy Compton, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: Margaret (Peggy) A Compton, RN, PhD University of California, Los Angeles
University of California, Los Angeles
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP