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NCT01740414 · ClinicalTrials.gov registry record · Phase 2
Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers
A Phase 2 study of Opioid Dependence and Opioid Abuse, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT01740414: Completed Phase 2 study of Opioid Dependence and Opioid Abuse, sponsored by New York State Psychiatric Institute.
NCT01740414 is a Phase 2 study of Opioid Dependence and Opioid Abuse that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 28 participants, below the 157-participant average among 29 other Opioid Dependence trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01740414, a Phase 2 study of Opioid Dependence and Opioid Abuse, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Participants are allowed to perform an operant task (click on a mouse) in order to receive a dose drug under investigation (oxycodone dose 0 mg, 15 mg, or 30 mg). The drug breakpoint is the maximum number of responses (mouse clicks) the participant was willing to make to receive the drug. Within the context of abuse liability studies, larger breakpoints represent greater abuse potential of a drug.
Conditions Studied
Interventions
- DRUG MN-166 (50 mg) First
- DRUG Placebo First
Study Locations (1)
New York
- New York State Psychiatric Institute - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-11 |
| Est. Completion | 2017-05 |
| Phase | Phase 2 |
What the finished NCT01740414 record still lists
NCT01740414 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 157-participant average among 29 other Opioid Dependence trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Opioid Dependence appearing as the primary indexed condition, and to 2 interventions - of which MN-166 (50 mg) First is the first listed.
NCT01740414 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01740414 about?
NCT01740414 is a clinical study titled "Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers". 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 comp...
What is the current status of trial NCT01740414?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2012-11. Estimated completion is 2017-05.
What conditions does trial NCT01740414 study?
This clinical trial studies the following conditions: Opioid Dependence, Opioid Abuse.
What interventions are being tested in trial NCT01740414?
The interventions under investigation include: MN-166 (50 mg) First (DRUG), Placebo First (DRUG).
Who is sponsoring clinical trial NCT01740414?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01740414 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01740414's enrollment target sits among peer trials
28 24th of 29 higher than 6 of 29 other Opioid Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Dependence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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