Randomized, Double-Blind Cross-Over Trial Of Buprenorphine and Low-Dose Naloxone Versus Buprenorphine

NCT00679458 | Completed

• 1 other identifier: 07-06-005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two medications for analgesic potency and side effects in a sample of individuals with moderate pain. After screening, eligible participants will be randomly assigned to begin blinded treatment with one of two medications. Participants receive 5 daily doses of medication (no more than 2 days between each dose) followed by crossover to the opposite treatment condition for 5 additional daily doses. Each study day, participants will provide a daily pain assessment, receive administration of study medication, and will then be monitored and assessed for pain and side effects over 6 hours.

Conditions

Pain

Keywords

analgesia; pain; buprenorphine; opioid; naloxone

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  After each dose of study drug

Secondary Outcomes (1)

• Self-reported side effects/adverse events

  after each daily dose of study drug

Study Arms (2)

1.

EXPERIMENTAL

Study drug: buprenorphine and ultra-low-dose naloxone

Drug: buprenorphine and low-dose naloxone

2.

ACTIVE COMPARATOR

Study drug: buprenorphine

Drug: buprenorphine alone

Interventions

buprenorphine and low-dose naloxone DRUG

each participant will be randomly assigned to order of study drug administration in a double-blind manner. Five doses of first study drug will be administered for 5 days, with each administration following the previous dose by not more than 2 days. Administration of the second study drug, buprenorphine only, will follow at least 2 days after the completion of the first study drug with the same administration criteria. Medication will be administered IV, and assessments will continue for 6 hours after administration. Study drugs include 1) buprenorphine 0.3mg and naloxone 0.02mg and, 2) buprenorphine 0.3mg.

1.

buprenorphine alone DRUG

each participant will be randomly assigned to order of study drug administration in a double-blind manner. Five doses of first study drug will be administered for 5 days, with each administration following the previous dose by not more than 2 days. Administration of the second study drug will follow at least 2 days after the completion of the first study drug with the same administration criteria. Medication will be administered IV, and assessments will continue for 6 hours after administration. Study drugs include 1) buprenorphine 0.3mg and naloxone 0.02mg and, 2) buprenorphine 0.3mg.

2.

Eligibility Criteria

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

You may qualify if:

• Participants must meet all of the following:
• years of age or older
• Have chronic pain that is not related to cancer, defined as pain expected to last a month or more,(i.e. musculoskeletal pain or neuropathic pain)
• Report pain of moderate to moderately-severe intensity during the week prior to the baseline screening visit (a score greater than or equal to 4 for average pain in the past week on the 0-10 point Pain Intensity-Numerical Rating Scale)
• Have used prescription opioid and/or non-opioid analgesics for the pain on at least 15 of the 30 days prior to the initial baseline/screening visit and have clearance from their prescribing physician to discontinue all non-study-related opiates during study participation
• Willing and able to comply with study procedures
• Willing and able to provide written consent
• If female, not pregnant or lactating and willing to use an acceptable method of birth control (e.g., condoms, IUD, birth control pills, or Depo-Provera)

You may not qualify if:

• Participants must not meet any of the following:
• Have a history of dependence on opiates, stimulants, alcohol, or benzodiazepines, as defined by DSM-IV criteria, within the past year (physical dependence on prescribed opioid analgesics is allowed but opioid dependence according to DSM-IV, i.e. opioid addiction, is not)
• Use of any illicit or recreational drugs (heroin, cocaine, methamphetamine, marijuana, etc.) ; or use of any long-acting opioid (i.e., methadone) in the 30 days prior to the initial screening visit
• Concomitant use of medications that are inhibitors of CYP3A4 (e.g., azole antifungals, macrolide antibiotics, and HIV protease inhibitors), or medications that induce CYP3A4 activity (e.g., anticonvulsants and rifampin) that may alter the metabolism of buprenorphine
• Have a current neurological disorder (e.g., organic brain disease, dementia) or current major psychiatric disorder (e.g., schizophrenia, bipolar illness, or PTSD) that would make study agent compliance difficult, that would compromise informed consent, or that would jeopardize safety
• Have a history of suicide attempts in the past 180 days and/or current serious suicidal risk
• Have any history of a seizure disorder
• Have a known allergy or sensitivity to buprenorphine or naloxone
• Receiving long-acting opioids, such as methadone, LAAM, or sustained release morphine, for treatment of pain (due to problems with initiating buprenorphine treatment among patients receiving long-acting opioids)
• Have recent surgery or a major medical procedure that could potentially interfere with study participation
• Any other circumstances that, in the opinion of the investigators, would interfere with study participation

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Indivior Inc.: collaborator

Study Sites (1)

UCLA Integrated Substance Abuse Programs Outpatient Research Center

Los Angeles, California, 90025', United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Buprenorphine; Naloxone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Walter Ling, M.D.

  UCLA Integrated Substance Abuse Programs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 7, 2010

Record last verified: 2009-11

Locations

US (1)