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Completed

NCT Number: NCT02413281

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

This study will evaluate the abuse potential of ALKS 5461.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alkermes Investigational Site

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALKS 5461

Drug

Sublingual tablets, single administration

buprenorphine

Drug

Sublingual tablets, single administration

Placebo

Drug

Sublingual tablets, single administration

Primary outcomes

  1. Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)

    Time frame: Approximately 14 weeks

Secondary outcomes

  1. Safety: Incidence of adverse events (AEs)

    Time frame: Up to 14 weeks

  2. Pharmacokinetics: Plasma concentrations of ALKS 5461

    Time frame: Up to 14 weeks

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 9, 2015
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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