Increased Sensitivity to Pain Caused by Opioids in People Who Have Abused Prescription Opioids
NCT ID: NCT01821430
Last Updated: 2017-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2013-03-31
2016-02-29
Brief Summary
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Detailed Description
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Following recruitment and screening, 75 subjects assigned to the active medication group will receive pregabalin 400 mg/day, a dose well-within published guidelines of 300-600 mg/day for the treatment of neuropathic pain (http://www.pfizerpro.com/hcp/lyrica/phndosing). During the first week of treatment, subjects will be quickly titrated up to the assigned daily PGB dose of 400 mg/day PO (50mg BID x 2 days; 100mg BID x 2 days; 150mg BID x 2 days, with full dosage of 400mg administered on day 7 ), or maximum dose tolerated) for six weeks. 75 subjects will be assigned to receive matched and undergo identical titration and study activities under double-blind conditions. Study staff will evaluate subjects daily by phone during titration; thereafter they will be seen weekly at study sessions. Tapering of medication will begin at the end of week 6. The severity of chronic pain will be measured at each time point using two standardized self report tools which report on pain severity (McGill Pain Questionnaire) and pain-related disability (Brief Pain Inventory). Opioid-induced hyperalgesia will be measured at each time point using a standardized cold pressor trial, and performance at baseline will be compared to performance following PGB/placebo administration over time.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Pregabalin
Pregabalin 400mg / Day
Pregabalin
Titration of intervention will begin with 50mg PO BID x 2 days, then 100mg PO BID x 2 days, then 150mg PO BID X 2 days, then on day 7 full dose of Pregabalin 400mg PO QD for six weeks
Placebo Control
Placebo Tablet
Placebo
Placebo group will follow the same titration as the pregabalin group
Interventions
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Pregabalin
Titration of intervention will begin with 50mg PO BID x 2 days, then 100mg PO BID x 2 days, then 150mg PO BID X 2 days, then on day 7 full dose of Pregabalin 400mg PO QD for six weeks
Placebo
Placebo group will follow the same titration as the pregabalin group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have a DSM-IVR diagnosis (used through 10/1/2014) of prescription opioid abuse or dependence disorder or a DSM-5 diagnosis of opioid use disorder.
3. Be enrolled and compliant in Suboxone or methadone treatment and on a stable dose \[Suboxone (6-24mg/day); of methadone (60-120mg/day)\] x at least 10 days.
4. Provide urine sample absent of any non-prescribed drugs of abuse at screening.
5. Screening cold-pressor pain tolerance \< 70 seconds
6. Have chronic lower back pain or arthritis pain (duration six or more months).
7. Be otherwise 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.
8. Be agreeable to and capable of signing an informed consent.
Exclusion Criteria
2. Potential participants must not be taking the following medications: pregabalin or gabapentin, tiagabine, vigabatrin, valproate, phenobarbital or primidone for the treatment of epilepsy; SNRI or TCA antidepressants; baclofen; or carbamazepine, oxycarbazepine or lamotrigine for the treatment of chronic pain.
3. Currently be substance dependent on alcohol, benzodiazepine, methamphetamine, cocaine or other drugs of abuse (except nicotine).
4. 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.
5. Be acutely psychotic, severely depressed and in need of inpatient treatment, or an immediate suicide risk.
6. Have a neurological or psychiatric illness (i.e., schizophrenia, Raynaud's disease, urticaria, stroke) that would affect pain responses.
7. Be currently taking opioid analgesic medication for a painful condition on a regular basis.
8. Be a nursing or pregnant female, or a female or male who does not agree to not become pregnant or father a child during the course of, and six months following completion of the study. If a subject becomes pregnant or fathers a child during the study, they must immediately notify the study investigator.
9. Have a history of heart disease, stroke, liver or kidney disease, epilepsy or acute hepatitis, or currently have a pacemaker or uncontrolled high blood pressure.
21 Years
65 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Georgetown University
OTHER
Responsible Party
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Peggy Compton
Professor and Associate Dean
Principal Investigators
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Peggy Compton, RN, PhD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University
Locations
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Georgetown University
Washington D.C., District of Columbia, United States
Countries
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References
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Backonja MM. Anticonvulsants (antineuropathics) for neuropathic pain syndromes. Clin J Pain. 2000 Jun;16(2 Suppl):S67-72. doi: 10.1097/00002508-200006001-00012.
Barrett AC, Smith ES, Picker MJ. Capsaicin-induced hyperalgesia and mu-opioid-induced antihyperalgesia in male and female Fischer 344 rats. J Pharmacol Exp Ther. 2003 Oct;307(1):237-45. doi: 10.1124/jpet.103.054478. Epub 2003 Sep 3.
Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia. 2004;45 Suppl 6:13-8. doi: 10.1111/j.0013-9580.2004.455003.x.
Blitz B, Dinnerstein AJ, Lowenthal M. Performance on the pain apperception test and tolerance for experimental pain: a lack of relationship. J Clin Psychol. 1968 Jan;24(1):73. doi: 10.1002/1097-4679(196801)24:13.0.co;2-5. No abstract available.
Chen ACN, Dworkin SF, Haug J, Gehrig J. Human pain responsivity in a tonic pain model: psychological determinants. Pain. 1989 May;37(2):143-160. doi: 10.1016/0304-3959(89)90126-7.
Chery-Croze S. Relationship between noxious cold stimuli and the magnitude of pain sensation in man. Pain. 1983 Mar;15(3):265-9. doi: 10.1016/0304-3959(83)90061-1.
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
Compton P, Charuvastra VC, Ling W. Pain intolerance in opioid-maintained former opiate addicts: effect of long-acting maintenance agent. Drug Alcohol Depend. 2001 Jul 1;63(2):139-46. doi: 10.1016/s0376-8716(00)00200-3.
Compton PA, Ling W, Torrington MA. Lack of effect of chronic dextromethorphan on experimental pain tolerance in methadone-maintained patients. Addict Biol. 2008 Sep;13(3-4):393-402. doi: 10.1111/j.1369-1600.2008.00112.x. Epub 2008 May 26.
Compton P, Kehoe P, Sinha K, Torrington MA, Ling W. Gabapentin improves cold-pressor pain responses in methadone-maintained patients. Drug Alcohol Depend. 2010 Jun 1;109(1-3):213-9. doi: 10.1016/j.drugalcdep.2010.01.006. Epub 2010 Feb 16.
Gore M, Tai KS, Zlateva G, Bala Chandran A, Leslie D. Clinical characteristics, pharmacotherapy, and healthcare resource use among patients with diabetic neuropathy newly prescribed pregabalin or gabapentin. Pain Pract. 2011 Nov-Dec;11(6):528-39. doi: 10.1111/j.1533-2500.2011.00450.x. Epub 2011 Mar 16.
Hansen GR. The drug-seeking patient in the emergency room. Emerg Med Clin North Am. 2005 May;23(2):349-65. doi: 10.1016/j.emc.2004.12.006.
Holtman JR Jr, Wala EP. Characterization of the antinociceptive and pronociceptive effects of methadone in rats. Anesthesiology. 2007 Mar;106(3):563-71. doi: 10.1097/00000542-200703000-00022.
Ifuku M, Iseki M, Hidaka I, Morita Y, Komatus S, Inada E. Replacement of gabapentin with pregabalin in postherpetic neuralgia therapy. Pain Med. 2011 Jul;12(7):1112-6. doi: 10.1111/j.1526-4637.2011.01162.x. Epub 2011 Jun 21.
Paulson MR, Dekker AH, Aguilar-Gaxiola S. Eliminating disparities in pain management. J Am Osteopath Assoc. 2007 Sep;107(9 Suppl 5):ES17-20.
Ramanujam VM, Anderson KE, Grady JJ, Nayeem F, Lu LJ. Riboflavin as an oral tracer for monitoring compliance in clinical research. Open Biomark J. 2011;2011(4):1-7. doi: 10.2174/1875318301104010001.
Tassone DM, Boyce E, Guyer J, Nuzum D. Pregabalin: a novel gamma-aminobutyric acid analogue in the treatment of neuropathic pain, partial-onset seizures, and anxiety disorders. Clin Ther. 2007 Jan;29(1):26-48. doi: 10.1016/j.clinthera.2007.01.013.
Tassorelli C, Micieli G, Osipova V, Rossi F, Nappi G. Pupillary and cardiovascular responses to the cold-pressor test. J Auton Nerv Syst. 1995 Oct 5;55(1-2):45-9. doi: 10.1016/0165-1838(95)00026-t.
Bodian D. Origin of specific synaptic types in the motoneuron neuropil of the monkey. J Comp Neurol. 1975 Jan 15;159(2):225-43. doi: 10.1002/cne.901590205.
Other Identifiers
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Pro00000669
Identifier Type: -
Identifier Source: org_study_id
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