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A Randomized, 4-sequence, 2-period, Double-blind, Placebo Controlled Study With a DSM-IV-TR Diagnosis of Cocaine Abuse

NCT01846481 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-09-23

No results posted yet for this study

Summary

This is a randomized, 4-sequence, 2-period, double-blind, placebo controlled study in male and female subjects with an American Psychiatric Association Diagnostic and Statistical Manual DSM-IV-TR diagnosis of cocaine abuse.

Conditions

  • Opioid Dependence
  • Opioid Related Disorders
  • Cocaine Dependence

Interventions

DRUG

RBP-8000 100 mg

RBP-8000 100 mg administered in the vein on either study day 3 or 6. There is a 72-hour washout between Days 3 and 6

DRUG

Placebo

IV infusion of Placebo administered 1 minute after cocaine infusion on either day 3 or 6.

DRUG

Cocaine

50 mg intravenous (IV) dose of cocaine administered over 10 minutes on Days 1, 3 and 6.

DRUG

RBP-8000 200 mg

RBP-8000 200 mg administered in the vein on either study day 3 or 6. There is a 72-hour washout between Days 3 and 6

Sponsors & Collaborators

  • Indivior Inc.

    lead INDUSTRY

Principal Investigators

  • Bradley D Vince, DO · Vince and Associates Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-06-30
Completion
2013-06-30

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 NCT01846481 on ClinicalTrials.gov