A Phase 2 interventional study of AV411 and Placebo (PCB) in Opioid-Related Disorders, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-05.
Sponsored by New York State Psychiatric Institute · Phase 2, Interventional, and Basic science
Repeated use and/or abuse of opioid medications is generally associated with a characteristic withdrawal syndrome that develops after cessation of drug administration. The present study is designed to evaluate the effectiveness of AV411 to alter opioid-induced withdrawal symptoms.
Opioid-induced cytokine release and glial activation has been proposed to directly contribute to the affective and physiological aspects of withdrawal. Furthermore, cytokine release following opioid administration has been hypothesized to be a limiting factor in both the duration and magnitude of opioid-induced analgesia. The two primary goals of our study are to assess AV411's ability to 1) reduce the opioid-withdrawal syndrome and 2) increase and prolong the analgesic effects of the mu-opioid agonist, oxycodone. To explore whether AV411 decreases opioid-induced glial cell activation, some participants assigned to the placebo and high dose AV411 groups (n = 6 for each dose condition) will be studied twice with [11C]PK11195, a positron emission tomography (PET) radiotracer used to measure the peripheral benzodiazepine receptor (PBR) in the human brain. The PBR is a receptor located on the mitochondria of the microglia and can be used to examine microglial activation in various brain regions.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 30 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will receive placebo drug
Drug: Placebo (PCB)
This group will receive a low dose of AV411
Drug: AV411
This group will receive a high dose of AV411
Drug: AV411
Low (20 mg), and high dose (40 mg) of AV411 will be administered orally twice a day (BID) for two consecutive weeks
Also known as: ibudilast
Placebo drug will be administered orally twice a day (BID) for two consecutive weeks
Also known as: PCB or 0 mg
Subjective Opioid Withdrawal Scale Score (SOWS)
Measures severity of opioid withdrawal in opioid dependent populations (0-64). Larger values indicate more severe withdrawal.
Time frame: Measured at the end of each two-week maintenance period (i.e., Placebo, Low AV411, High AV411).
The Effects of AV411 on the Analgesic Effects of Oxycodone.
The McGill Pain Questionnaire (Melzack, 1987) was used to assess pain experience immediately following the immersion of the hand in 4 degree Celsius water. Scores were added across all 15 items to generate a sum score, which ranged between 15 and 60. Larger scores indicate greater pain levels.
Time frame: Measured at the end of each AV411 of the three two-week maintenance periods
| Milestone | Placebo | Low-dose AV411 | High-dose AV411 |
|---|---|---|---|
| Started | 15 | 14 | 15 |
| Completed | 10 | 10 | 10 |
| Not completed | 5 | 4 | 5 |
Measures severity of opioid withdrawal in opioid dependent populations (0-64). Larger values indicate more severe withdrawal.
| units on a scale | Placebo | Low-dose AV411 | High-dose AV411 |
|---|---|---|---|
| Subjective Opioid Withdrawal Scale Score (SOWS) | 16 ± 4 | 4 ± 2 | 24 ± 10 |
The McGill Pain Questionnaire (Melzack, 1987) was used to assess pain experience immediately following the immersion of the hand in 4 degree Celsius water. Scores were added across all 15 items to generate a sum score, which ranged between 15 and 60. Larger scores indicate greater pain levels.
| units on a scale | Placebo | Low-dose AV411 | High-dose AV411 |
|---|---|---|---|
| The Effects of AV411 on the Analgesic Effects of Oxycodone. | 40 ± 5 | 42 ± 7 | 38 ± 5 |
Collected over We assessed for adverse events daily throughout the study and at 1 and 3 month follow-up time points. If a serious adverse events was experienced, it would have been reported to the appropriate oversight authorities within 24-48 hours.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/15 (0%) | 5/15 (33.3%) |
| Low-dose AV411 | — | 0/14 (0%) | 2/14 (14.3%) |
| High-dose AV411 | — | 0/15 (0%) | 5/15 (33.3%) |
| Event | Placebo | Low-dose AV411 | High-dose AV411 |
|---|---|---|---|
| GI upset and ConstipationGastrointestinal disorders | 3/15 | 2/14 | 2/15 |
| InsomniaSocial circumstances | 2/15 | 2/14 | 3/15 |
| Age, Categorical(Participants) | Placebo | Low-dose AV411 | High-dose AV411 | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 14 | 15 | 44 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(Year) | Placebo | Low-dose AV411 | High-dose AV411 | Total |
|---|---|---|---|---|
| Mean | 39 ± 4.5 | 38 ± 5.3 | 38 ± 4.3 | 38 ± 4.8 |
| Sex: Female, Male(Participants) | Placebo | Low-dose AV411 | High-dose AV411 | Total |
|---|---|---|---|---|
| Female | 1 | 2 | 1 | 4 |
| Male | 14 | 12 | 14 | 40 |
| Region of Enrollment(participants) | Placebo | Low-dose AV411 | High-dose AV411 | Total |
|---|---|---|---|---|
| United States | 15 | 14 | 15 | 44 |
Plan to share: Yes — Data have been published in a peer-reviewed journal.
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New York State Psychiatric Institute