ClinicalTrials.Veeva

Menu

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

Alkermes logo

Alkermes

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Buprenorphine
Drug: ALKS 5461
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02413281
ALK5461-212

Details and patient eligibility

About

This study will evaluate the abuse potential of ALKS 5461.

Enrollment

56 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

56 participants in 6 patient groups, including a placebo group

ALKS 5461 Dose 1
Experimental group
Description:
Sublingual tablets
Treatment:
Drug: ALKS 5461
ALKS 5461 Dose 2
Experimental group
Description:
Sublingual tablets
Treatment:
Drug: ALKS 5461
ALKS 5461 Dose 3
Experimental group
Description:
Sublingual tablets
Treatment:
Drug: ALKS 5461
Buprenorphine Dose 1
Active Comparator group
Description:
Sublingual tablets
Treatment:
Drug: Buprenorphine
Buprenorphine Dose 2
Active Comparator group
Description:
Sublingual tablets
Treatment:
Drug: Buprenorphine
Placebo
Placebo Comparator group
Description:
Sublingual tablets
Treatment:
Drug: Placebo

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems