A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | March 2015 |
| End Date: | September 2015 |
A Phase 1, Single-Dose, Double-Blind, Placebo-and Active-Controlled, Randomized, 6-way Crossover Human Abuse Liability Evaluation of ALKS 5461
This study will evaluate the abuse potential of ALKS 5461.
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.
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