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

NCT02651584 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2019-08-22

Study results available
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Summary

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/NX) in initiation and maintenance treatment with BPN.

Conditions

  • Opioid Use Disorders

Interventions

DRUG

CAM2038 SC injection

DRUG

SL BPN/NX tabs

DRUG

placebo SC injections

DRUG

SL placebo tablets

Sponsors & Collaborators

  • Braeburn Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Braeburn Pharmaceuticals · Braeburn Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-10-31
Completion
2016-11-30

Countries

  • United States

Study Locations

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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 NCT02651584 on ClinicalTrials.gov