A Study to Assess the Abuse Potential of Hydrocodone Extended-Release Tablet in Recreational Opioid Users
Condition: Drug Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the relative abuse potential of the hydrocodone
      bitartrate extended-release tablet compared to immediate-release hydrocodone bitartrate.
    

Detailed description: 
      Hydrocodone bitartrate is a semisynthetic opioid analgesic and antitussive. Hydrocodone is
      widely used for various indications similar to those of codeine, primarily for relief of
      moderate to moderately severe pain. For the treatment of pain in the United States,
      hydrocodone is currently available only as an immediate-release (IR) product in combination
      with other medications such as acetaminophen or ibuprofen. The extended-release (ER)
      formulation tested in this study is designed to be resistant to dose dumping with alcohol or
      rapid release of hydrocodone after tampering.

      The study will consist of 3 phases: A, B,and C. Phase A is the screening phase where subject
      eligibility will be confirmed (Visit 1). Subjects who are eligible will enter Phase B, a
      double-blind, 2-period crossover design (Visit 2) followed by Phase C, a double-blind
      4-period crossover design (Visits 3 through 6).

      Phase B is the randomized, double-blind, placebo-controlled, 2-treatment, 2- period crossover
      portion of the study which is designed to ensure that the subject can tolerate a 45-mg dose
      of hydrocodone and that the subject can discriminate between the effect of hydrocodone and
      the effect of placebo. Subjects will arrive at the study center on the day prior to the first
      study drug administration and remain at the study center for a minimum of 24 hours after the
      second study drug administration in phase B. After a review of the inclusion/exclusion
      criteria and check-in procedures (including a Naloxone Challenge),eligible subjects will be
      randomly assigned to one of 2 treatment sequences. For subjects who qualify to continue into
      phase C, there will be a minimum 7-day washout period between the second dose in phase B and
      the first dose in phase C.

      Phase C is the randomized, double-blind, triple-dummy, placebo-controlled, 4-period crossover
      portion of the study. Subjects will arrive at the study center the day prior to each study
      drug administration in phase C and remain at the study center through 72 hours after study
      drug administration in each period. Eligible subjects will be randomly assigned to 1 of 4
      treatment groups. Each dose in phase C will be separated by a minimum 14 day washout period.

      All subjects (including those who withdraw from the study) will be asked to return to the
      study center for a follow-up visit approximately 48 to 72 hours after discharge from the
      study center following their final dose of study drug.
    

Intervention name(s): 45-mg hydrocodone bitartrate extended-release tablet (crushed or intact); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Phase B:
Eligible subjects will be randomized to treatment sequence XY or YX whereby treatment X is 60 mL of a noncarbonated flavored beverage and treatment Y is hydrocodone bitartrate powder at a dose strength of 45-mg reconstituted in 60 mL of a noncarbonated flavored beverage.
Phase C:
Eligible subjects will be randomly assigned to 1 of 4 treatment arms:
Treatment A: intact placebo tablet, 60 mL noncarbonated flavored beverage, 1 crushed 45-mg hydrocodone bitartrate extended-release tablet.
Treatment B: intact placebo tablet, hydrocodone bitartrate powder at a dose strength of 45-mg in 60 mL of a noncarbonated flavored beverage and 1 crushed placebo tablet.
Treatment C: intact 45-mg hydrocodone bitartrate extended-release tablet, 60 mL noncarbonated flavored beverage, and 1 crushed placebo tablet Treatment D: intact placebo tablet, 60 mL noncarbonated flavored beverage, and 1 crushed placebo tablet.; Placebo will consist of 60 mL of a non-carbonated beverage without the addition of active treatment
Other intervention name(s): hydrocodone
Intervention MeSH terms: Hydrocodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment