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Phase 1 Study to Evaluate RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults

NCT01046539 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-01-11

No results posted yet for this study

Summary

This is a single site, double-blind, randomized, placebo-controlled, crossover study to assess the pharmacodynamics (PD) of RDC-0313 coadministered with buprenorphine in 12 healthy, opioid-experienced, non-treatment-seeking subjects.

Conditions

  • Substance-Related Disorders

Interventions

DRUG

RDC-0313 + Buprenorphine

1 and 4 mg (1 dose for each) + 8 mg

DRUG

Placebo

0 mg

Sponsors & Collaborators

  • Alkermes, Inc.

    collaborator INDUSTRY

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-03-31
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01046539 on ClinicalTrials.gov