A Phase 2 interventional study of Medisorb naltrexone 75 mg and Medisorb naltrexone 150 mg in Opiate Dependence, sponsored by Alkermes, Inc.. Completed. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-11.
Sponsored by Alkermes, Inc. · Phase 2, Interventional, and Treatment
This was a Phase 2, multicenter, randomized, double-blind pilot study in opioid-using adults to assess the presence, duration, and degree of opiate blockade as well as the safety and tolerability of Medisorb® naltrexone (VIVITROL®). Subjects were randomized in a 1:1:1 ratio to receive a single gluteal intramuscular (IM) injection of Medisorb naltrexone 75, 150, or 300 mg.
Potential subjects were screened within 21 days prior to dosing of study drug (Medisorb naltrexone or placebo) on Day 0. Screening evaluations included a baseline hydromorphone challenge session in which increasing doses of hydromorphone (0 mg [placebo], 3 mg, 4.5 mg, and 6 mg) were administered at hourly intervals to produce a cumulative dose-response curve. Throughout the 4-hour challenge period, subject-rated measures (Visual Analog Scale [VAS] questions) and physiological measures (ie, pupil size) were recorded.
As a safety measure, at least 7 days after the baseline hydromorphone challenge, a naloxone challenge was performed followed by a 1-day oral naltrexone tolerability assessment. On Day 0, eligible subjects were administered a single dose of study drug. To assess the level of opiate blockade and surmountability attributable to Medisorb naltrexone, experimental hydromorphone challenge sessions were conducted postdose at Days 7, 14, 21, 28, 42, and 56, with a single placebo hydromorphone challenge administered at a randomly selected visit. Pupil size was measured 15 minutes prior to the first hydromorphone dose and at 15, 30, 45, and minutes after each ascending hydromorphone/placebo for hydromorphone dose. Blood samples for measurement of naltrexone and 6B-naltrexol were obtained at screening and before hydromorphone/placebo administration on Days 7, 14, 21, 28, 42, and 56.
Subjects were monitored for safety through Day 56.
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Primary Inclusion Criteria:
Primary Exclusion Criteria:
Drug: Medisorb naltrexone 75 mg · Drug: Hydromorphone (10 mg/mL) · Drug: Naloxone Challenge and Oral Naltrexone Tolerability Testing
Drug: Medisorb naltrexone 150 mg · Drug: Hydromorphone (10 mg/mL) · Drug: Naloxone Challenge and Oral Naltrexone Tolerability Testing
Drug: Medisorb naltrexone 300 mg · Drug: Hydromorphone (10 mg/mL) · Drug: Naloxone Challenge and Oral Naltrexone Tolerability Testing
Single administration via intramuscular (IM) injection.
Also known as: Naltrexone for extended-release injectable suspension
Single administration via IM injection.
Also known as: Naltrexone for extended-release injectable suspension
Single administration via IM injection.
Also known as: Naltrexone for extended-release injectable suspension
Increasing doses of 0, 3, 4.5, and 6 mg were administered at baseline (pre-study drug administration). After study drug administration, additional hydromorphone challenge sessions consisting of administering 0, 3, 4.5, and 6 mg were administered at 1-hr intervals at each of the postdose evaluation visits. In addition, at a randomly selected evaluation visit, subjects received four 0 mg (placebo) doses at 1-hour intervals.
Also known as: Dilaudid-HP®, opioid agonist
Administered according to the instructions provided by the respective manufacturer. Testing occurred at least 7 days after the baseline hydromorphone challenge and prior to study drug administration.
Also known as: Narcan® (naloxone), ReVia® (oral naltrexone)
Slope Change From Baseline for Pupil Size
Photographs of subjects' pupils were measured horizontally and vertically, 15 minutes before the first hydromorphone dose and every 15 minutes after each hydromorphone/placebo for hydromorphone dose, for up to 1 hour. Size was the product of vertical and horizontal measures. The slope, determined by linear regression, was used as a summary measure of the dose-response relationship between the hydromorphone dose and pupil size. The steeper the slope, the greater the hydromorphone effect. A slope of zero indicated no evidence of a hydromorphone effect.
Time frame: 4 weeks (Baseline to Day 28)
| Milestone | Medisorb Naltrexone 75 mg | Medisorb Naltrexone 150 mg | Medisorb Naltrexone 300 mg |
|---|---|---|---|
| Started | 9 | 8 | 10 |
| Completed | 8 | 6 | 7 |
| Not completed | 1 | 2 | 3 |
Photographs of subjects' pupils were measured horizontally and vertically, 15 minutes before the first hydromorphone dose and every 15 minutes after each hydromorphone/placebo for hydromorphone dose, for up to 1 hour. Size was the product of vertical and horizontal measures. The slope, determined by linear regression, was used as a summary measure of the dose-response relationship between the hydromorphone dose and pupil size. The steeper the slope, the greater the hydromorphone effect. A slope of zero indicated no evidence of a hydromorphone effect.
| cm(2)/hr | Medisorb Naltrexone 75 mg | Medisorb Naltrexone 150 mg | Medisorb Naltrexone 300 mg |
|---|---|---|---|
| Slope Change From Baseline for Pupil Size | -0.5540 ± 0.3473 | -0.3607 ± 0.3998 | -0.1410 ± 0.1745 |
Collected over 56 Days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Medisorb Naltrexone 75 mg | — | 0/9 (0%) | 6/9 (66.7%) |
| Medisorb Naltrexone 150 mg | — | 0/8 (0%) | 5/8 (62.5%) |
| Medisorb Naltrexone 300 mg | — | 0/10 (0%) | 7/10 (70%) |
| Event | Medisorb Naltrexone 75 mg | Medisorb Naltrexone 150 mg | Medisorb Naltrexone 300 mg |
|---|---|---|---|
| Application site rashGeneral disorders | 0/9 | 1/8 | 0/10 |
| FatigueGeneral disorders | 0/9 | 1/8 | 1/10 |
| Injury NOSInjury, poisoning and procedural complications | 1/9 | 1/8 | 0/10 |
| Joint sprainInjury, poisoning and procedural complications | 0/9 | 1/8 | 0/10 |
| Limb injury NOSInjury, poisoning and procedural complications | 0/9 | 1/8 | 0/10 |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/9 | 1/8 | 0/10 |
| Headache NOSNervous system disorders | 1/9 | 1/8 | 1/10 |
| Libido decreasedPsychiatric disorders | 0/9 | 1/8 | 0/10 |
| ContusionSkin and subcutaneous tissue disorders | 0/9 | 1/8 | 0/10 |
| Abdominal pain upperGastrointestinal disorders | 1/9 | 0/8 | 0/10 |
| Age, Categorical(Participants) | Medisorb Naltrexone 75 mg | Medisorb Naltrexone 150 mg | Medisorb Naltrexone 300 mg | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 8 | 10 | 27 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Medisorb Naltrexone 75 mg | Medisorb Naltrexone 150 mg | Medisorb Naltrexone 300 mg | Total |
|---|---|---|---|---|
| Mean | 35.22 ± 9.28 | 42.88 ± 4.70 | 32.5 ± 8.02 | 36.48 ± 8.60 |
| Gender(Participants) | Medisorb Naltrexone 75 mg | Medisorb Naltrexone 150 mg | Medisorb Naltrexone 300 mg | Total |
|---|---|---|---|---|
| Female | 1 | 0 | 2 | 3 |
| Male | 8 | 8 | 8 | 24 |
| Region of Enrollment(participants) | Medisorb Naltrexone 75 mg | Medisorb Naltrexone 150 mg | Medisorb Naltrexone 300 mg | Total |
|---|---|---|---|---|
| United States | 9 | 8 | 10 | 27 |
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Alkermes, Inc.