A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users

November 9, 2015 updated by: Alkermes, Inc.

A Phase 1, Single-Dose, Double-Blind, Placebo-and Active-Controlled, Randomized, 6-way Crossover Human Abuse Liability Evaluation of ALKS 5461

This study will evaluate the abuse potential of ALKS 5461.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Alkermes Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive, and a minimum weight of at least 50.0 kg
  • Be a current recreational opioid user who has used opioids for non-therapeutic purposes (ie for psychoactive effects) at least 10 times in their lifetime
  • Agree to use an approved method of contraception for the duration of the study unless surgically sterile or postmenopausal
  • Be willing and able to abide by all study requirements and restrictions
  • Additional criteria may apply

Exclusion Criteria:

  • Have evidence of drug or alcohol dependence within the past 2 years
  • Have a positive drug screen for opioids, amphetamines, cocaine, or benzodiazepines upon admission to the clinic
  • Have a history of severe allergic reaction (including anaphylaxis) to any food, medication, or bee sting
  • Be currently pregnant, breastfeeding, or planning to become pregnant during the study
  • Currently have or have a history of allergy or hypersensitivity to opioid agonists, opioid antagonists or related drugs (eg, oxycodone, morphine, naltrexone, and naloxone)
  • Have a positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
  • Have donated or lost more than 500 mL whole blood
  • Additional criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALKS 5461 Dose 1
Sublingual tablets
Drug: ALKS 5461
Sublingual tablets, single administration
Experimental: ALKS 5461 Dose 2
Sublingual tablets
Drug: ALKS 5461
Sublingual tablets, single administration
Experimental: ALKS 5461 Dose 3
Sublingual tablets
Drug: ALKS 5461
Sublingual tablets, single administration
Active Comparator: Buprenorphine Dose 1
Sublingual tablets
Drug: Buprenorphine
Sublingual tablets, single administration
Active Comparator: Buprenorphine Dose 2
Sublingual tablets
Drug: Buprenorphine
Sublingual tablets, single administration
Placebo Comparator: Placebo
Sublingual tablets
Drug: Placebo
Sublingual tablets, single administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)
Time Frame: Approximately 14 weeks
Approximately 14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety: Incidence of adverse events (AEs)
Time Frame: Up to 14 weeks
Up to 14 weeks
Pharmacokinetics: Plasma concentrations of ALKS 5461
Time Frame: Up to 14 weeks
Up to 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Investigators

  • Study Director: Sanjeev Pathak, MD, Alkermes, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Estimate)

November 10, 2015

Last Update Submitted That Met QC Criteria

November 9, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK5461-212

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.

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