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Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder

NCT02672111 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2020-05-15

Study results available
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Summary

Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.

Conditions

Interventions

DRUG

CAM2038 q1w or q4w exposure to SL BPN/NX

DRUG

CAM2038 q1w or q4w new to BPN treatment

Sponsors & Collaborators

  • Braeburn Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Michael Frost, MD · Frost Medical Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United States
  • Australia
  • Denmark
  • Germany
  • Hungary
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02672111 on ClinicalTrials.gov