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

NCT01821430 | Terminated Phase 2

• 2 other identifiers: Pro00000669U01DA029580
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Chronic Pain; Narcotic Abuse; Opioid related disorders; Opiate substitution treatment; Buprenorphrine; Pregabalin; Methadone

Outcome Measures

Primary Outcomes (1)

• Improved Pain Response, threshold and tolerance

  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.

  8 weeks

Secondary Outcomes (1)

• Improvement in pain severity and daily functionality

  8 weeks

Study Arms (2)

Pregabalin

EXPERIMENTAL

Pregabalin 400mg / Day

Drug: Pregabalin

Placebo Control

PLACEBO COMPARATOR

Placebo Tablet

Drug: Placebo

Interventions

Pregabalin DRUG

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

Also known as: Lyrica

Pregabalin

Placebo DRUG

Placebo group will follow the same titration as the pregabalin group

Placebo Control

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between the ages of 21 and 65 years of age.
• 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.
• 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.
• Provide urine sample absent of any non-prescribed drugs of abuse at screening.
• Screening cold-pressor pain tolerance \< 70 seconds
• Have chronic lower back pain or arthritis pain (duration six or more months).
• 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.
• Be agreeable to and capable of signing an informed consent.

You may not qualify if:

• Have known sensitivity to pregabalin or gabapentin.
• 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.
• Currently 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, 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.
• 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.

Sponsors & Collaborators

• Georgetown University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (19)

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MeSH Terms

Conditions

Chronic Pain; Narcotic-Related Disorders; Opioid-Related Disorders

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Peggy Compton, RN, PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Dean

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 1, 2013
• Study Start: March 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

US (1)