Status:
COMPLETED
Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?
Lead Sponsor:
University of California, Los Angeles
Conditions:
Opioid-Induced Hyperalgesia
Eligibility:
All Genders
21-55 years
Phase:
PHASE2
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 complica...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01210079
Start Date
September 1 2002
End Date
May 1 2010
Last Update
April 6 2012
Active Locations (1)
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1
UCLA School of Nursing
Los Angeles, California, United States, 90095