Opiate Dependence Clinical Trial
Official title:
A Randomized, Single-Dose Opiate Challenge Study of Medisorb® Naltrexone in Opioid-Using Adults
Verified date | January 2011 |
Source | Alkermes, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | May 2003 |
Est. primary completion date | May 2003 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Alkermes, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 4 weeks (Baseline to Day 28) | No |
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