Summary:
The purpose of this study is to assess treatment efficacy and adherence of OX219(Buprenorphine/Naloxone) versus SUBOXONE Film (Buprenorphine/Naloxone)and to explore switching between treatments.
Inclusion Criteria:
- Male/female 18 - 65 years old
- Able to read, comprehend & sign the informed consent form
- Meet opioid dependence criteria in DSM-IV-TR the past 12 months
- Have a Buprenorphine-negative UDS &/or urine dipstick
- Prepared to abstain from opioids other than the study drug & from other addictive drugs
- Negative urine pregnancy test
- Females of childbearing potential who use a reliable method of contraception. Females of non-childbearing potential; surgically sterile or post-menopausal as defined by being at least 50 years of age & having an absence of menses for at least 2 years
- Clearance from the prescribing MD to be withdrawn from their prescribed opioids for subjects receiving opioids for pain
- Lack of clinically significant abnormalities in health assessments performed at screening. Unclear cases should be approved by the medical monitor
- At leastmild withdrawal symptoms (COWS ≥ 9)
Qualified Participants May Receive:
Investigational medication and all study related visits at no cost. Possible compensation for each completed visit.