Recruiting

Buprenorphine

Sponsor:

UCLA

Code:

NCT02136784

Conditions

Analgesic Response

Eligibility Criteria

Sex: Male

Age: 20 - 50

Healthy Volunteers: Not accepted

Interventions

morphine sulfate

hydrocodone

hydromorphone HCI

oxycodone

buprenorphine

Study Details

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

Study ID

NCT02136784

Start date

Apr, 2014

Status verified date

May, 2014

Completion date

Dec, 2014

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 20 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Interventions and Outcome Measures

Arms

experimental: morphine sulfate

30mg, single dose,

experimental: hydrocodone

10mg single dose

experimental: hydromorphone HCI

4mg single dose

experimental: oxycodone

10 mg single dose

experimental: buprenorphine

4 mg single dose

placebo comparator: oral tablet placebo

single dose

placebo comparator: sublingual tablet placebo

single dose

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.

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.

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.

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.

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.

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.

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.

Primary outcome measure

  • Pain detection [ Time Frame: 7 testing sessions over 12 weeks ]
  • Pain tolerance [ Time Frame: 7 testing sessions over 12 weeks ]

Central Contacts and Locations

Central contacts

Maureen Hillhouse, PhD

310-267-5308hillhous@ucla.edu

Locations

UCLA Integrated Substance Abuse Programs Outpatient Clinical Research Center

Recruiting

Los Angeles, California, United States, 90025

Contacts

Maureen Hillhouse, PhD

310-267-5308hillhous@ucla.edu

Principal Investigator:

Walter Ling, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

May 13, 2014

Last verified

May, 2014

Keywords

  • pain
  • cold presser test
  • buprenorphine
  • opioids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2014-05-13.