ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids

NCT01218984 | Completed Phase 2 Results

• 1 other identifier: ALK21-004
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Opiate Dependence

Keywords

Opiate Dependence

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

Medisorb naltrexone 75 mg

EXPERIMENTAL

Drug: Medisorb naltrexone 75 mg; Drug: Hydromorphone (10 mg/mL); Drug: Naloxone Challenge and Oral Naltrexone Tolerability Testing

Medisorb naltrexone 150 mg

EXPERIMENTAL

Drug: Medisorb naltrexone 150 mg; Drug: Hydromorphone (10 mg/mL); Drug: Naloxone Challenge and Oral Naltrexone Tolerability Testing

Medisorb naltrexone 300 mg

EXPERIMENTAL

Drug: Medisorb naltrexone 300 mg; Drug: Hydromorphone (10 mg/mL); Drug: Naloxone Challenge and Oral Naltrexone Tolerability Testing

Interventions

Medisorb naltrexone 75 mg DRUG

Single administration via intramuscular (IM) injection.

Also known as: Naltrexone for extended-release injectable suspension

Medisorb naltrexone 75 mg

Medisorb naltrexone 150 mg DRUG

Single administration via IM injection.

Also known as: Naltrexone for extended-release injectable suspension

Medisorb naltrexone 150 mg

Medisorb naltrexone 300 mg DRUG

Single administration via IM injection.

Also known as: Naltrexone for extended-release injectable suspension

Medisorb naltrexone 300 mg

Hydromorphone (10 mg/mL) DRUG

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

Medisorb naltrexone 150 mg; Medisorb naltrexone 300 mg; Medisorb naltrexone 75 mg

Naloxone Challenge and Oral Naltrexone Tolerability Testing DRUG

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)

Medisorb naltrexone 150 mg; Medisorb naltrexone 300 mg; Medisorb naltrexone 75 mg

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Related Publications (1)

• Bigelow GE, Preston KL, Schmittner J, Dong Q, Gastfriend DR. Opioid challenge evaluation of blockade by extended-release naltrexone in opioid-abusing adults: dose-effects and time-course. Drug Alcohol Depend. 2012 Jun 1;123(1-3):57-65. doi: 10.1016/j.drugalcdep.2011.10.018. Epub 2011 Nov 12.

  PMID: 22079773 RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Naltrexone; Hydromorphone; Analgesics, Opioid; Naloxone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Morphine Derivatives; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Bernard L. Silverman, VP, Clinical Development
• Organization: Alkermes, Inc.

bernard.silverman@alkermes.com

781-609-6000

Study Officials

• Bernard L. Silverman, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 13, 2010
• Study Start: March 1, 2002
• Primary Completion: May 1, 2003
• Study Completion: May 1, 2003
• Last Updated: January 11, 2017
• Results First Posted: December 13, 2010

Record last verified: 2016-11