To Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: Hydrocodon bitartrate-acetaminophen arm 1; Drug: Hydrocodon bitartrate-acetaminophen arm 2; Drug: Reference

• Registration Number: NCT03567941
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

Evaluation of abuse potential in recreational abusers of Hydrocodone Bitartrate and Acetaminophen versus NORCO®.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-29
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-06-22
• Study First Posted: 2018-06-26
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-26
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Healthy male or female subjects 18 to 55 years of age.
2. Opioid users who have used opioids for recreational purposes and or is an avid opioid user.

Exclusion Criteria

1. Substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years.
2. Heavy smoker and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine containing products for at least 6 hours during the in-clinic periods.
3. Difficulty swallowing large number of pills.
4. Subjects who have had a tattoo or body piercing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hydrocodon bitartrate-acetaminophen arm 1	Hydrocodon bitartrate-acetaminophen arm 1	Single dose
Hydrocodon bitartrate-acetaminophen arm 1	Hydrocodon bitartrate-acetaminophen arm 2	Single dose
Placebo	Placebo	Single dose
Placebo	Hydrocodon bitartrate-acetaminophen arm 1	Single dose
Placebo	Hydrocodon bitartrate-acetaminophen arm 2	Single dose
Placebo	Reference	Single dose
Hydrocodon bitartrate-acetaminophen arm 1	Placebo	Single dose
Hydrocodon bitartrate-acetaminophen arm 1	Reference	Single dose
Hydrocodon bitartrate-acetaminophen arm 2	Placebo	Single dose
Hydrocodon bitartrate-acetaminophen arm 2	Hydrocodon bitartrate-acetaminophen arm 1	Single dose
Hydrocodon bitartrate-acetaminophen arm 2	Hydrocodon bitartrate-acetaminophen arm 2	Single dose
Hydrocodon bitartrate-acetaminophen arm 2	Reference	Single dose
Reference	Placebo	Single dose
Reference	Hydrocodon bitartrate-acetaminophen arm 1	Single dose
Reference	Hydrocodon bitartrate-acetaminophen arm 2	Single dose
Reference	Reference	Single dose

Primary Outcome Measures

Name	Time	Method
Drug Liking	15 weeks	Visual analog scale on score from 0 to 100

Trial Locations

Locations (1)

SPARC Site 1; 🇨🇦 Toronto, Ontario, Canada