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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-09-30

Brief Summary

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This study will evaluate the abuse potential of ALKS 5461.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Intervention Type DRUG

Sublingual tablets, single administration

Interventions

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ALKS 5461

Sublingual tablets, single administration

Intervention Type DRUG

Buprenorphine

Sublingual tablets, single administration

Intervention Type DRUG

Placebo

Sublingual tablets, single administration

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes