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Abuse Liability of Suboxone Versus Subutex

NCT00710385 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-12-05

Study results available
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Summary

The study is designed to compare the abuse liabilities of intravenous buprenorphine and buprenorphine/naloxone in individuals who are physically dependent on sublingual buprenorphine. We hypothesize that the abuse liability of buprenorphine/naloxone is lower than that of buprenorphine alone.

Conditions

  • Opioid-related Disorders

Interventions

DRUG

Heroin

Heroin (25 mg)

DRUG

Naloxone

.4 mg

DRUG

Low Bup Dose

4 and 8 mg

DRUG

High Bup Dose

8mg and 16 mg

DRUG

Low Bup/Nal Dose

Buprenorphine/Naloxone 4/1 mg, 8/2 mg

DRUG

High Bup/Nal Dose

Buprenorphine/Naloxone 8/2 mg, 16/4 mg

DRUG

Placebo (PCB)

Placebo control administration

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Sandra D Comer, PhD · Columbia University/New York State Psychiatric Institute

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-08-31
Completion
2008-08-31

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 NCT00710385 on ClinicalTrials.gov