Analgesic Response to Opioid Analgesics in Buprenorphine-Maintained Individuals

NCT ID: NCT02136784

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-12-31

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.

Detailed Description

Study design is a single-blind examination of the analgesic effects of a single dose of seven test medications provided in an experimental pain paradigm using a cold pressor test (CPT). Test medication conditions include buprenorphine, morphine, hydromorphone, hydrocodone, oxycodone, and two placebo conditions to match test medication formulations (oral tablet, sublingual tablet). Each medication condition will be tested on separate days (seven total days, completing within 12 weeks), with random assignment to order of study medications. After screening, eligible participants will be scheduled for 7 days of testing with test days at least 3 days apart to provide a sufficient medication wash-out period. Pain testing will utilize cold pressor tests (CPT), in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance. Participants will be given a practice trial to provide familiarity with the test and reduce test anxiety. Two CPTs will occur on each test day, and pre- and post-CPT assessments will be administered. Blood samples will be taken on each test day to measure blood levels of buprenorphine. Daily procedures include: (1) A baseline CPT (BL-CPT), (2) Administration of the test medication (active drug or placebo), (3) CPT administered at the time of maximum drug effect (Tmax-CPT) specific to medication (range 30-120 minutes), (4) Pupillometry conducted at baseline (before BL-CPT), and at time of maximum drug effect (before Tmax-CPT). Each participant will be discharged after clinical determination of the participant's safety and well-being. Testing will continue until twelve trials of each medication condition are completed.

Conditions

Analgesic Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

morphine sulfate

30mg, single dose,

Group Type: EXPERIMENTAL

oral tablet placebo

Intervention Type: 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.

hydrocodone

10mg single dose

Group Type: EXPERIMENTAL

oral tablet placebo

Intervention Type: 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.

hydromorphone HCI

4mg single dose

Group Type: EXPERIMENTAL

oral tablet placebo

Intervention Type: 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.

oxycodone

10 mg single dose

Group Type: EXPERIMENTAL

oral tablet placebo

Intervention Type: 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.

buprenorphine

4 mg single dose

Group Type: EXPERIMENTAL

sublingual tablet placebo

Intervention Type: 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.

oral tablet placebo

single dose

Group Type: PLACEBO_COMPARATOR

morphine sulfate

Intervention Type: 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.

hydrocodone

Intervention Type: 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.

hydromorphone HCI

Intervention Type: 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.

oxycodone

Intervention Type: 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.

sublingual tablet placebo

single dose

Group Type: PLACEBO_COMPARATOR

buprenorphine

Intervention Type: 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.

Interventions

morphine sulfate

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.

Intervention Type: DRUG

hydrocodone

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.

Intervention Type: DRUG

hydromorphone HCI

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.

Intervention Type: DRUG

oxycodone

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.

Intervention Type: DRUG

buprenorphine

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.

Intervention Type: DRUG

oral tablet placebo

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.

Intervention Type: DRUG

sublingual tablet placebo

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.

Intervention Type: DRUG

Other Intervention Names

30 mg, single dose; 10mg single dose; 4 mg single dose; 10 mg single dose; 4 mg single dose; single dose; single dose

Eligibility Criteria

Inclusion Criteria

1. Male, in good general health

2. 20-50 years old

3. Fluent in English

4. Maintained on buprenorphine for at least 3 months

5. Able to complete testing/assessments for 7 test days within 12 weeks

6. Approved for participation by buprenorphine-prescribing physician

Exclusion Criteria

1. Known hypersensitivity to any of the test opioids

2. Urine test positive for opioids (other than buprenorphine) or other illicit substances

3. 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.

4. Presence of acute pain condition or planned surgery during the study period

5. Unstable vital signs as determined by the study physician.

6. 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;

7. Pending legal action or other situation that might prevent remaining in the area for the duration of the study

8. Current medical or psychiatric condition that could detract from study objectives, place the participant at risk, or interfere with treatment goals

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Indivior Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Walter Ling

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Walter Ling, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Integrated Substance Abuse Programs Outpatient Clinical Research Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica Jenkins, MA

Role: CONTACT

jenkinsj@ucla.edu

310-267-5318

Maureen Hillhouse, PhD

Role: CONTACT

hillhous@ucla.edu

310-267-5308

Facility Contacts

Jessica Jenkins, MS

Role: primary

jenkinsj@ucla.edu

310-267-5318

Maureen Hillhouse, PhD

Role: backup

hillhous@ucla.edu

310-267-5308

Other Identifiers

13-001175

Identifier Type: -

Identifier Source: org_study_id