Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers
Status:
Completed
Trial end date:
2017-05-01
Target enrollment:
Participant gender:
Summary
Opioid drugs increase glial cell activation which may be related to the abuse liability of
opioid drugs. Data supporting this hypothesis have demonstrated that glial cell attenuators
decrease the positive rewarding aspect of opioids in laboratory animals. Ibudilast (MN-166,
formerly AV411) is a compound that inhibits the activation of glia. Recent preclinical
studies demonstrate that while ibudilast increases the analgesic effects of opioids, it
decreases the rewarding effects of such drugs. It has also been shown that ibudilast
suppresses morphine-induced release of dopamine, a primary neurotransmitter involved in the
rewarding and reinforcing effects of abused drugs. Additionally, we recently found that
ibudilast decreases subjective symptoms of opioid withdrawal in opioid dependent humans
during detoxification.
Therefore, the primary aim of this 6-7 week inpatient study is to investigate the ability of
MN-166 to dose-dependently alter the reinforcing, analgesic, subjective, performance, and
physiological effects of oxycodone, a commonly abused prescription opioid.
This study includes a 10-day morphine taper phase, followed by two study phases
(approximately 18 days each) with daily active ibudilast and placebo administration,
respectively. After the detoxification phase, participants are randomized to receive placebo
or MN-166, and then be stabilized on the medication. Thereafter, participants will complete
laboratory sessions. Subsequently, during Phase 2, participants will cross over to the other
treatment arm, stabilize, and complete laboratory sessions.
Phase:
Phase 2
Details
Lead Sponsor:
New York State Psychiatric Institute
Collaborators:
MediciNova National Institute on Drug Abuse (NIDA)