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

PHASE1CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2012

Conditions
Drug Abuse
Interventions
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

Trial Locations (2)

Unknown

Cephalon Investigational Site 001, Salt Lake City

Cephalon Investigational Site 100, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cephalon

INDUSTRY