Overview

Analgesic Response to Opioid Analgesics in Buprenorphine-Maintained Individuals

Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, Los Angeles
Collaborator:
Indivior Inc.
Treatments:
Analgesics
Analgesics, Opioid
Buprenorphine
Hydrocodone
Hydromorphone
Morphine
Oxycodone
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