drugset / Trial / NCT01821430
Increased Sensitivity to Pain Caused by Opioids in People Who Have Abused Prescription Opioids
Phase 2
Terminated
4 enrolled
Georgetown University
National Institute on Drug Abuse (NIDA) · collab
RandomizedSingle-groupQuadruple-blindTreatment
Summary
Managing pain in patients who abuse prescription opioids presents many challenges, including the development of opioid-induced hyperalgesia (OIH). Hyperalgesia is a condition in which something that usually feels slightly painful is perceived as something very painful. The proposed study will test the efficacy of the well-known neurological medication pregabalin to diminish OIH and chronic pain in persons who are in Suboxone (buprenorphine) or methadone treatment for prescription drug abuse.
Timeline
- Start
- 2013-03
- Primary completion
- 2016-02
- Completion
- 2016-02
Publications
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- Background 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.
- Background 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.
- Background 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.
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- Background 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.
- Background 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.
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- Background 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.
- Background 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.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pregabalin | Small molecule | 400 mg | Oral |