NCT01596673

A Study to Assess the Abuse Potential of Hydrocodone Extended-Release Tablet in Recreational Opioid Users

A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Abuse Potential of the Hydrocodone Bitartrate Extended-Release Tablet in Healthy, Nondependent, Recreational Opioid Users

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Drug Abuse

Interventions

Type	Name	Description
DRUG	45-mg hydrocodone bitartrate extended-release tablet (crushed or intact)	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.
DRUG	Placebo	Placebo will consist of 60 mL of a non-carbonated beverage without the addition of active treatment

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-05-11
• Last updated: 2012-11-21

Locations

2 sites across 2 countries: United States, Canada