Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1

January 13, 2017 updated by: National Institute on Drug Abuse (NIDA)

CS1008A Efficacy/Safety Trial of Buprenorphine/Naloxone

The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The developmental objective for this combination product is an expansion of therapeutic options for the treatment of opiate dependence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This multicenter pivotal clinical trial was comprised of two phases. The first phase, which was four weeks in length, was double-blind placebo controlled and was primarily used to evaluate the efficacy of buprenorphine/naloxone. The second phase, lasting 48 weeks, was primarily conducted to determine the safety of buprenorphine/naloxone.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Cincinnati MDRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. DSM-IV (Diagnostic and Statistical Manual of the American Psychiatric Association) diagnosis of current opiate dependence.
  2. Individuals seeking opiate-substitution pharmacotherapy for opiate dependence.
  3. Males and non-pregnant, non-nursing females, 18 to 59 years of age (inclusive).
  4. Individuals able to give informed consent and willing to comply with all study procedures (e.g., providing of urine samples under observation, completing questionnaires).

Exclusion Criteria:

  1. Any acute or chronic medical condition that would make participation in the study medically hazardous (e.g., acute hepatitis, unstable cardiovascular, hepatic, or renal disease, unstable diabetes, symptomatic AIDS; not HIV-seropositivity alone).
  2. Aspartate or alanine aminotransferase (AST, ALT) levels greater than three times the upper limit of normal.
  3. Individuals currently taking systemic anti-retroviral or anti-fungal therapy.
  4. Current dependence (by DSM-IV criteria) on any psychoactive substance other than opiates, caffeine, or nicotine.
  5. Current, primary, Axis I psychiatric diagnosis other than opiate, caffeine, or nicotine dependence.

  6. Females of childbearing potential who do not agree to use a medically acceptable method of birth control. Acceptable methods include

    1. oral contraceptive,
    2. barrier (diaphragm or condom) - a spermicide is not required due to the possibility of local irritation and allergic type reactions, but are recommended for use,
    3. levonorgestrel implant,
    4. intrauterine progesterone contraceptive system,
    5. medroxyprogesterone acetate contraceptive injection, or
    6. complete abstinence.
  7. Enrollment in an opiate-substitution (i.e., methadone, levo-alpha-acetylmethadol) treatment program within 45 days of enrolling in the present study.
  8. Individuals having taken (licitly or illicitly) LAAM, methadone, or naltrexone within days of enrolling in the present study.
  9. Individuals having taken buprenorphine, other than as an analgesic, within 365 days of enrolling in the present study.
  10. Participation in an investigational drug or device study within 45 days of enrolling in the present study.
  11. Anyone, who in the opinion of site principal investigator, would not be expected to complete the first phase of the study protocol (e.g., due to pending incarceration or probable relocation from the clinic area).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse events
Craving
Drug use
HIV risk behaviors
Medical evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

Cincinnati MDRU

Investigators

  • Principal Investigator: Eugene Somoza, M.D., Ph.D., Cincinnati MDRU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1996

Primary Completion (Actual)

December 1, 1996

Study Completion (Actual)

January 1, 1997

Study Registration Dates

First Submitted

April 18, 2001

First Submitted That Met QC Criteria

April 17, 2001

First Posted (Estimate)

April 18, 2001

Study Record Updates

Last Update Posted (Estimate)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

November 1, 1996

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-5-0012-1
  • Y01-5-0012-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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