Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence

This is a Phase III, randomized, double-blind, double-dummy, active-controlled, parallel
group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an
existing standard of care (SL BPN) in initiation and maintenance treatment with BPN. The
trial will involve 4 phases: Screening, Phase 1 (weekly visits), Phase 2 (monthly visits),
and Follow-up.

Approximately 380 subjects (190 subjects per arm) will be randomized.

Inclusion Criteria:

1. Subject must provide written informed consent prior to the conduct of any
trial-related procedures.

2. Male or female, 18-65 years of age, inclusive.

3. Diagnosis of moderate or severe opioid use disorder (DSM-V).

4. Voluntarily seeking treatment for opioid use disorder.

5. Have not received medication-assisted treatment for opioid use disorder within 60
days prior to randomization.

6. Considered by the Investigator to be a good candidate for BPN treatment, based on
medical and psychosocial history.

7. Female subjects of childbearing potential must be willing to use a reliable method of
contraception during the entire trial (Screening visit to Follow-up visit)

Exclusion Criteria:

1. Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS).

2. Current diagnosis of chronic pain requiring opioids for treatment.

3. Current DSM-V diagnosis for moderate to severe substance use disorder on any other
psychoactive substances other than opioids, caffeine or nicotine (e.g., alcohol,
cocaine, sedatives).

4. Pregnant or lactating or planning to become pregnant during the trial.

5. Hypersensitivity or allergy to BPN or other opioids, naloxone or other opioid
antagonists, or excipients of CAM2038 or SL BPN.

6. Requires current use of agents that are strong inhibitors or inducers of cytochrome
P450 3A4 (CYP3A4) such as some azole antifungals (e.g., ketoconazole), macrolide
antibiotics (e.g., clarithromycin), or protease inhibitors (e.g., ritonavir,
indinavir, and saquinavir).

7. Active hepatitis. Subjects with no significant viral load, no acute signs of
inflammation, and no clinical necessity for therapy will be allowed, at the
discretion of the Investigator.

8. Recent history of or current evidence of suicidal ideation or active suicidal
behavior as based on the Columbia Suicide Severity Rating Scale (C-SSRS) ("Yes"
responses to questions 4 or 5).

9. Any pending legal action that could prohibit participation or compliance in the
trial.

10. Exposure to any investigational drug within the 4 weeks prior to Screening.

11. Participants with a history of risk factors of Torsades de Pointes (e.g., heart
failure, hypokalemia, family history of Long QT Syndrome) or an electrocardiogram
(ECG) demonstrating a Fridericia's corrected QT interval (QTcF) >450 msec in males
and QTcF >470 in females at screening.

12. Aspartate aminotransferase (AST) levels >3 X the upper limit of normal, alanine
aminotransferase (ALT) levels >3 X the upper limit of normal, total bilirubin >1.5 X
the upper limit of normal, or creatinine >1.5 X upper limit of normal on the
Screening laboratory assessments, or other clinically significant laboratory
abnormalities, which in the opinion of the Investigator may prevent the subject from
safely participating in trial.

13. Significant symptoms, medical conditions, or other circumstances which, in the
opinion of the Investigator, would preclude compliance with the protocol, adequate
cooperation in the trial or obtaining informed consent, or may prevent the subject
from safely participating in trial (including, but not limited to, the risks
described as precautions, warnings, and contraindications in the current version of
the Investigator's Brochure for CAM2038).

14. Is an employee of the Investigator or the trial site, with direct involvement in the
proposed trial or other trials under the direction of the Investigator or trial site,
or is a family member of an employee or of the Investigator.