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Trial record 27 of 186 for:    BUPRENORPHINE AND NALOXONE

Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00015028
Recruitment Status : Completed
First Posted : April 18, 2001
Last Update Posted : January 16, 2017
Cincinnati MDRU
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Substance-Related Disorders Drug: Buprenorphine/naloxone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: CS1008A Efficacy/Safety Trial of Buprenorphine/Naloxone
Study Start Date : November 1996
Actual Primary Completion Date : December 1996
Actual Study Completion Date : January 1997

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Craving
  2. Drug use
  3. HIV risk behaviors
  4. Adverse events
  5. Medical evaluation

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00015028

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United States, Ohio
Cincinnati MDRU
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Cincinnati MDRU
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Principal Investigator: Eugene Somoza, M.D., Ph.D. Cincinnati MDRU

Layout table for additonal information Identifier: NCT00015028     History of Changes
Other Study ID Numbers: NIDA-5-0012-1
First Posted: April 18, 2001    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: November 1996
Keywords provided by National Institute on Drug Abuse (NIDA):
opioid dependence
Additional relevant MeSH terms:
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Buprenorphine, Naloxone Drug Combination
Substance-Related Disorders
Opioid-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists