Back to resultsHyperalgesia in Methadone-Maintained Patients: Can it be Treated?
Primary Purpose
Opioid-Induced Hyperalgesia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gabapentin;
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Induced Hyperalgesia focused on measuring opioid-induced hyperalgesia, methadone, gabapentin, opioid addiction
Eligibility Criteria
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.
Sites / Locations
- UCLA School of Nursing
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gabapentin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in Pain Threshold Time From Baseline to Week 5
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01210079
First Posted
September 27, 2010
Last Updated
March 11, 2012
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT01210079
Brief Title
Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?
Official Title
Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Induced Hyperalgesia
Keywords
opioid-induced hyperalgesia, methadone, gabapentin, opioid addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Gabapentin;
Intervention Description
Gabapentin titrated to daily dose of 2400mg PO over 1 week with established dose taken daily for 5 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo titrated over 1 week with established dose taken daily for 5 weeks.
Primary Outcome Measure Information:
Title
Change in Pain Threshold Time From Baseline to Week 5
Description
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.
Time Frame
baseline, 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret (Peggy) A Compton, RN, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA School of Nursing
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
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Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?
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