Analgesic Response to Opioid Analgesics in Buprenorphine-Maintained Individuals

NCT02136784 | Unknown

• 1 other identifier: 13-001175
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to examine the effects of opioid analgesics on acute pain in participants maintained on buprenorphine+naloxone (Suboxone) for opioid use disorders. Seven medication conditions will be tested in a cold pressor test (CPT) paradigm.

Conditions

Analgesic Response

Keywords

pain; cold presser test; buprenorphine; opioids

Outcome Measures

Primary Outcomes (2)

• Pain detection

  Pain detection is defined as the number of seconds it takes for the participant to feel pain.

  7 testing sessions over 12 weeks

• Pain tolerance

  Pain tolerance is defined as the number of seconds it takes before the participant removes his hand from the ice water.

  7 testing sessions over 12 weeks

Secondary Outcomes (1)

• Pupillometry results

  7 testing sessions over 12 weeks

Study Arms (7)

morphine sulfate

EXPERIMENTAL

30mg, single dose,

Drug: oral tablet placebo

hydrocodone

EXPERIMENTAL

10mg single dose

Drug: oral tablet placebo

hydromorphone HCI

EXPERIMENTAL

4mg single dose

Drug: oral tablet placebo

oxycodone

EXPERIMENTAL

10 mg single dose

Drug: oral tablet placebo

buprenorphine

EXPERIMENTAL

4 mg single dose

Drug: sublingual tablet placebo

oral tablet placebo

PLACEBO COMPARATOR

single dose

Drug: morphine sulfate; Drug: hydrocodone; Drug: hydromorphone HCI; Drug: oxycodone

sublingual tablet placebo

PLACEBO COMPARATOR

single dose

Drug: buprenorphine

Interventions

morphine sulfate DRUG

Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.

Also known as: 30 mg, single dose

oral tablet placebo

hydrocodone DRUG

Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.

Also known as: 10mg single dose

oral tablet placebo

hydromorphone HCI DRUG

Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.

Also known as: 4 mg single dose

oral tablet placebo

oxycodone DRUG

Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.

Also known as: 10 mg single dose

oral tablet placebo

buprenorphine DRUG

Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.

Also known as: 4 mg single dose

sublingual tablet placebo

oral tablet placebo DRUG

Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.

Also known as: single dose

hydrocodone; hydromorphone HCI; morphine sulfate; oxycodone

sublingual tablet placebo DRUG

Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.

Also known as: single dose

buprenorphine

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male, in good general health
• years old
• Fluent in English
• Maintained on buprenorphine for at least 3 months
• Able to complete testing/assessments for 7 test days within 12 weeks
• Approved for participation by buprenorphine-prescribing physician

You may not qualify if:

• Known hypersensitivity to any of the test opioids
• Urine test positive for opioids (other than buprenorphine) or other illicit substances
• Current use of any additional opioid or analgesic medication (other than buprenorphine), medical marijuana, MAOI, tricyclic antidepressant, duloxetine, gabapentin, pregabalin, or other medication considered unsafe or having potential to influence pain perception as determined by study physician.
• Presence of acute pain condition or planned surgery during the study period
• Unstable vital signs as determined by the study physician.
• Current pattern of alcohol, benzodiazepine, or other sedative hypnotic use, as determined by the study medical clinician, which would preclude safe participation in the study;
• Pending legal action or other situation that might prevent remaining in the area for the duration of the study
• Current medical or psychiatric condition that could detract from study objectives, place the participant at risk, or interfere with treatment goals

Sponsors & Collaborators

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

Study Sites (1)

UCLA Integrated Substance Abuse Programs Outpatient Clinical Research Center

Los Angeles, California, 90025, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Morphine; Hydrocodone; Oxycodone; Buprenorphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; 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; Codeine

Study Officials

• Walter Ling, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Jenkins, MA

CONTACT

310-267-5318; jenkinsj@ucla.edu

Maureen Hillhouse, PhD

CONTACT

310-267-5308; hillhous@ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: May 13, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

US (1)