Study to Assess OX219 (Buprenorphine/Naloxone) for the Induction of Treatment of Opioid Dependence

Inclusion Criteria:

- Able to read, comprehend, and sign the informed consent form and willingly provide
written informed consent

- Prepared to engage in opioid replacement therapy and to abstain from opioid
utilization other than the study drug, and from other illicit drugs.

- Male or female, 18 to 65 years old, inclusive.

- Meet the criteria for opioid dependence as defined in the DSM-IV-TR, in the past 12
months.

- Have a BUP-negative urine drug screen and/or urine dipstick result before
randomization.

- Have a negative urine pregnancy test

- For females of childbearing potential: Using a reliable method of contraception
(e.g., hormonal, condom with spermicide, intrauterine device [IUD]) after the
screening visit and for the duration of the study.

- For participants receiving opioids for pain, clearance from their prescribing
physician to be withdrawn from their prescribed opioids.

- Generally good health as determined by the investigator

- Subjects should demonstrate at least mild withdrawal symptoms (defined as a COWS
score >9) at Day 1 predose.

Exclusion Criteria:

- Females who are pregnant or lactating, or planning to be pregnant during study.

- Any previous prescribed treatment with BUP monotherapy (e.g., generic BUP SL
tablets).

- Prescribed treatment with BUP or NAL within 90 days prior to start of treatment.

- Methadone patients with any daily dose over 30 mg during the past week and who
received the last dose of methadone less than 30 hours prior to start of treatment.

- Participants who are unwilling or unable to comply with the requirements of the
protocol

- Participants who are participating in any other clinical study in which medication(s)
are being delivered or who have used an investigational drug or device within the
last 30 days.

- Participants with any known allergy or sensitivity or intolerance to BUP, NAL, or any
related drug

- Participants who are on the staff, affiliated with, or a family member of the staff
personnel directly involved with this study.

- Participants with serious untreated Axis I DSM-IV-TR psychiatric comorbidity

- Tongue piercing or other piercings in the mouth, including lips and cheek.

- Participations with current or history of clinically significant medical disorder or
condition

- Subjects who are human immunodeficiency virus (HIV)-seropositive with a CD4+ count <
200 or active acquired immune deficiency syndrome (AIDS)

- Participants who have any Class III or IV congestive heart failure, symptomatic
myocardial ischemia, a history of long QT syndrome.

- Participants who are currently taking Class 1A antiarrhythmic medications or Class
III antiarrhythmic medications

- Participants who have uncontrolled hypertension or clinically significant ECG
abnormalities

- Participants who have a pulse oximetry ≤93% at screening, due to any medical reason.

- Subject has AST or ALT levels ≥3 X the upper limit of normal or total bilirubin or
creatinine ≥1.5 X ULN, on the screening laboratory assessments

- Participants with known significant liver disease.

- Participants who take any medication, nutraceutical, herbal product with known CYP3A4
inhibition or induction properties within 14 days of screening.

- Participants who are at suicidal risk