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Trial record 94 of 424 for:    Pregabalin

Increased Sensitivity to Pain Caused by Opioids in People Who Have Abused Prescription Opioids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01821430
Recruitment Status : Terminated (poor recruitment)
First Posted : April 1, 2013
Last Update Posted : February 9, 2017
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Peggy Compton, Georgetown University

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Pregabalin Drug: Placebo Phase 2

Detailed Description:

The clinical management of pain in prescription opioid abusers presents a challenge to the health care professional. Investigators have novel pilot data showing that the GABA-agonist gabapentin (GPN) significantly decreases opioid-induced hyperalgesia (OIH) in methadone patients (Compton et al., 2009), providing the first empirical evidence of a pharmacotherapy for OIH in opioid abusers. The work of Gore and colleagues (2011) showed that pregabalin (PGB), a GABA analogue succeeding GPN, was shown to decrease opioid use in patients with neuropathic pain in patients, suggesting an anti-hyperalgesia effect not observed in the matched cohort receiving GPN. The proposed research will comprehensively evaluate the efficacy of PGB in treating opioid-induced hyperalgesia (OIH) in a well-described population of prescription opioid abusers (POAs) with chronic pain and on Suboxone (buprenorphine) or methadone therapy. A pressing need for such investigation is presented by the rising number of POAs presenting for treatment (SAMHSA, 2010; 2011), and for whom, chronic pain is a common co-morbidity. The proposed work is anticipated to provide vital and timely information on the efficacy of PGB in the treatment of OIH in prescription opioid abusers on Suboxone or methadone therapy.

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 ( 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Opioid-Induced Hyperalgesia in Prescription Opioid Abusers: Effects of Pregabalin
Actual Study Start Date : March 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: Pregabalin
Pregabalin 400mg / Day
Drug: 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
Other Name: Lyrica

Placebo Comparator: Placebo Control
Placebo Tablet
Drug: Placebo
Placebo group will follow the same titration as the pregabalin group

Primary Outcome Measures :
  1. Improved Pain Response, threshold and tolerance [ Time Frame: 8 weeks ]

    To test the efficacy of PGB, compared to placebo, to diminish OIH, as evidenced by improved pain responses (threshold and tolerance) to experimentally induced cold-pressor pain, in a well-described sample of POA patients with chronic pain and on buprenorphine or methadone therapy.

    • Pain Threshold: On the CP assay, pain threshold is operationalized as the number of seconds after the onset of the painful stimulus when a painful sensation is first detected. Subjects will indicate threshold by saying "Pain."
    • Pain Tolerance: On the CP assay, pain tolerance is operationalized as the number of seconds after the onset of the painful stimulus when the painful sensation is subjectively intolerable. Subjects will indicate tolerance by removing their arm from the ice bath.

Secondary Outcome Measures :
  1. Improvement in pain severity and daily functionality [ Time Frame: 8 weeks ]

    To test the efficacy of PGB, compared to placebo, to diminish chronic pain, as evidenced by improvements in pain severity and functionality in a well-described sample of POA patients with chronic pain and on buprenorphine or methadone therapy.

    Pain Severity will be measured with The McGill Pain Questionnaire. Daily Functionality will be measured with the Brief Pain Inventory

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Be between the ages of 21 and 65 years of age.
  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:

  1. Have known sensitivity to pregabalin or gabapentin.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01821430

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United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Peggy Compton, RN, PhD Georgetown University


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Responsible Party: Peggy Compton, Professor and Associate Dean, Georgetown University Identifier: NCT01821430     History of Changes
Other Study ID Numbers: Pro00000669
U01DA029580 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2013    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peggy Compton, Georgetown University:
Chronic Pain
Narcotic Abuse
Opioid related disorders
Opiate substitution treatment

Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs