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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ALKS 5461; Drug: Buprenorphine; Drug: Placebo

• Registration Number: NCT02413281
• Lead Sponsor: Alkermes, Inc.

Brief Summary

This study will evaluate the abuse potential of ALKS 5461.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ALKS 5461 Dose 2	ALKS 5461	Sublingual tablets
ALKS 5461 Dose 3	ALKS 5461	Sublingual tablets
ALKS 5461 Dose 1	ALKS 5461	Sublingual tablets
Buprenorphine Dose 1	Buprenorphine	Sublingual tablets
Buprenorphine Dose 2	Buprenorphine	Sublingual tablets
Placebo	Placebo	Sublingual tablets

Primary Outcome Measures

Name	Time	Method
Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)	Approximately 14 weeks

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events (AEs)	Up to 14 weeks
Pharmacokinetics: Plasma concentrations of ALKS 5461	Up to 14 weeks

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇺🇸 Overland Park, Kansas, United States