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

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

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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