CompletedNCT01210079Updated Apr 6, 2012Results posted

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

A Phase 2 interventional study of Gabapentin; and Placebo in Opioid-Induced Hyperalgesia, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years. Per ClinicalTrials.gov, last updated 2012-04-06.

Sponsored by University of California, Los Angeles · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 26
Allocation: Randomized
Ages: 21 Years to 55 Years
Sex: All

Study 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 studied

Opioid-Induced Hyperalgesia

Browse trials for

Hyperalgesia 152

Keywords

opioid-induced hyperalgesia
methadone
gabapentin
opioid addiction

In context

Hyperalgesia

152 studies on the registry are indexed under Hyperalgesia; 13 are open to participants now.

This study's enrollment of 26 is below the median of 42 across 127 interventional studies indexed under Hyperalgesia.

Browse Hyperalgesia studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 26 participants (actual)

Study arms

Experimental
Gabapentin
Drug: Gabapentin;
Placebo comparator
Placebo
Drug: Placebo

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: baseline, 5 weeks

Results

Posted Apr 6, 2012

Limitations and caveats

Baseline hyperalgesia not established. Duration of trial only 5 weeks. Findings can only be generalized to methadone-maintained patients who are able to abstain from illicit drug use over an extended period of time.

Participant flow

Participant flow — Overall Study
Milestone	Gabapentin	Placebo
Started	10	16
Completed	10	16
Not completed	0	0

Outcome measures

PrimaryChange 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.

Time frame:: baseline, 5 weeks
Reported as:: Mean · seconds

Change in Pain Threshold Time From Baseline to Week 5
seconds	Gabapentin	Placebo
Change in Pain Threshold Time From Baseline to Week 5	2.95 ± 2.41	-3.49 ± 2.85

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Gabapentin	—	0/10 (0%)	0/10 (0%)
Placebo	—	0/16 (0%)	0/16 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Gabapentin	Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	10	16	26
>=65 years	0	0	0

Age Continuous
Age Continuous(years)	Gabapentin	Placebo	Total
Mean	45.5 ± 4.46	49.5 ± 4.96	47.9 ± 5.05

Sex: Female, Male
Sex: Female, Male(Participants)	Gabapentin	Placebo	Total
Female	5	7	12
Male	5	9	14

Region of Enrollment
Region of Enrollment(participants)	Gabapentin	Placebo	Total
United States	10	16	26

Study locations

1 site

UCLA School of Nursing
Los Angeles, California 90095, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01210079
Lead sponsor: University of California, Los Angeles
Responsible party: Peggy Compton (Professor, Associate Dean for Academic Affairs, University of California, Los Angeles) — Principal investigator
First posted: Sep 28, 2010
Start date: Sep 2002
Primary completion: Mar 2008
Completion: May 2010
Results posted: Apr 6, 2012
Last update: Apr 6, 2012

Study contacts

Margaret (Peggy) A Compton, RN, PhD

principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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