ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids
A Randomized, Single-Dose Opiate Challenge Study of Medisorb® Naltrexone in Opioid-Using Adults
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Primary Inclusion Criteria:
- Adults who had used opioids: non-medically for at least 1 year; at least once per week for at least some period during their use history; and fewer than 3 times per week on average for the 30 days prior to screening.
- Provided written informed consent
- Demonstrated a positive response to hydromorphone challenge during screening
- Willing to use contraception for study duration if of childbearing potential
Primary Exclusion Criteria:
- Any clinically significant medical condition or laboratory abnormality at screening
- Participated in a clinical trial within prior 30 days
- Dependent on opioids
- Seeking treatment for opioid abuse
- Psychosis or any major mood or anxiety disorder
- Pregnancy or lactation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Medisorb naltrexone 75 mg
|
Single administration via intramuscular (IM) injection.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: Medisorb naltrexone 150 mg
|
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.
Other Names:
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.
Other Names:
Single administration via IM injection.
Other Names:
|
|
EXPERIMENTAL: Medisorb naltrexone 300 mg
|
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.
Other Names:
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.
Other Names:
Single administration via IM injection.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Slope Change From Baseline for Pupil Size
Time Frame: 4 weeks (Baseline to Day 28)
|
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.
|
4 weeks (Baseline to Day 28)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Alcohol Deterrents
- Naltrexone
- Naloxone
- Hydromorphone
Other Study ID Numbers
- ALK21-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.