Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users
Condition: Nondependent Opioid Abuse, Episodic
MeSH terms: Opioid-Related Disorders; Crush Injuries
Intervention: Placebo; MS Contin (morphine sulfate, controlled release); EMBEDA (morphine sulfate / naltrexone hydrochloride)
Intervention description: Single-dose, 2 x microcrystalline cellulose (weighed to equal weights of average tablet/capsule of active comparator) mixed with 150 ml artificially sweetened, non-carbonated beverage; Single-dose, 2 x 60 mg morphine sulfate whole tablets manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage; Single-dose, solution 2 x 60 mg morphine sulfate with sequestered 2.4 mg Naltrexone hydrochloride whole capsules manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage
Intervention MeSH terms: Naltrexone; Morphine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: abuse potential; abuse liability; recreational opioid use; morphine

Summary:

      The primary purpose of this study is to determine the abuse potential of EMBEDA compared to
      controlled release morphine when crushed and taken orally by non-dependent recreational
      opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA
      relative to placebo and and to compare the pharmacokinetics and safety of crushed EMBEDA with
      crushed controlled-release morphine and crushed placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a recreational opioid user who is NOT physically dependent on opioids based
             on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision
             (DSM-IV-TR) criteria, and the Naloxone Challenge. A recreational opioid user is
             defined as recreationally abusing opioids for non-therapeutic purposes (i.e., for
             psychoactive effects) on at least 10 occasions within the last year and at least once
             in the 12 weeks prior to Visit 1.

          -  Subject is in generally good health as determined by medical history, physical
             examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram
             (ECG).

        Exclusion Criteria:

          -  Has a history or current diagnosis of substance dependence (excluding caffeine and
             nicotine), as assessed by the Investigator using the DSM IV-TR criteria.

          -  Has participated in, is currently participating in, or is seeking treatment for
             substance- and/or alcohol-related disorders (excluding nicotine and caffeine).

          -  History or presence of any clinically significant illness (e.g., cardiovascular,
             pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic,
             dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other
             condition, which in the opinion of the Investigator would jeopardize the safety of the
             subject or the validity of the study results.

          -  Has a known allergy or history of hypersensitivity to morphine sulfate, opioids in
             general, naltrexone hydrochloride (HCl) or similar compounds and/or the known
             excipients in the investigational drug products.

          -  Has any condition in which an opioid is contraindicated (e.g., significant respiratory
             depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having
             paralytic ileus).

          -  Females who are pregnant, lactating, or are planning to become pregnant during the
             course of the study. Females with a positive serum pregnancy test at Visit 1 or at any
             subsequent study visit will be excluded from participating in the study.