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

NCT ID: NCT01210079

Last Updated: 2012-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2010-05-31

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.

Conditions

Opioid-Induced Hyperalgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Gabapentin

Group Type: EXPERIMENTAL

Gabapentin;

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Gabapentin;

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Peggy Compton

Professor, Associate Dean for Academic Affairs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret (Peggy) A Compton, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA School of Nursing

Los Angeles, California, United States

Countries

United States

Other Identifiers

R01 DA 05463

Identifier Type: -

Identifier Source: org_study_id