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Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1

This study has been completed.
Cincinnati MDRU
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: April 18, 2001
Last updated: January 13, 2017
Last verified: November 1996
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 Intervention Phase
Opioid-Related Disorders Substance-Related Disorders Drug: Buprenorphine/naloxone Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: CS1008A Efficacy/Safety Trial of Buprenorphine/Naloxone

Resource links provided by NLM:

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Craving
  • Drug use
  • HIV risk behaviors
  • Adverse events
  • Medical evaluation

Estimated Enrollment: 0
Study Start Date: November 1996
Study Completion Date: January 1997
Primary Completion Date: December 1996 (Final data collection date for primary outcome measure)
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.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00015028

United States, Ohio
Cincinnati MDRU
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Cincinnati MDRU
Principal Investigator: Eugene Somoza, M.D., Ph.D. Cincinnati MDRU
  More Information Identifier: NCT00015028     History of Changes
Other Study ID Numbers: NIDA-5-0012-1
Study First Received: April 18, 2001
Last Updated: January 13, 2017

Keywords provided by National Institute on Drug Abuse (NIDA):
opioid dependence

Additional relevant MeSH terms:
Substance-Related Disorders
Opioid-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists processed this record on September 19, 2017