A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers
CompletedPhase 1NCT01746901
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
Brief summary (from the registry)
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.
Study details
- Official title
- A Randomized, Double-blind, Double-dummy, Placebo Controlled, Single-dose, 6-way Crossover Study To Determine The Relative Abuse Potential Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended-release Capsules) Compared To Oxycodone Immediate Release And Placebo When Administered Orally To Nondependent,Recreational Opioid Users.
- Conditions
- Interventions
- Drug: Placebo
- Drug: intact ALO-02 60 mg/7.2 mg
- Drug: crushed ALO-02 60 mg/7.2 mg
- Drug: crushed oxycodone IR 60 mg
- Drug: crushed ALO-02 40 mg/4.8 mg
- Drug: crushed oxycodone IR 40 mg
- Sponsor
- Pfizer
- Collaborators
- Syneos Health
- Start date
- 2013-02
- Primary completion
- 2013-08-09
- Sex
- All
- Age range
- from 18 Years to 55 Years
- Healthy volunteers
- true
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Healthy subjects. * Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic purposes on at least 10 occassions within the last year before Screening Visit, and at least once in 8 weeks before the Screening Visit. Exclusion Criteria: * Diagnosis of substance and/or alcohol dependence. * Subject has participated in, is currently participating in, or is seeking treatment for substance and/or alcohol related disorder. * History of sleep apnea. * Positive urine drug screen (UDS) for other that marijuana. * Positive for Hepatitis B or C and HIV on Screening.
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01746901