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Buprenorphine/Naloxone Versus Clonidine for Outpatient Opiate Detoxification - 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: NCT00032968
Recruitment Status : Completed
First Posted : April 8, 2002
Last Update Posted : January 12, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
The purpose of this study is to assess buprenorphine/naloxone versus clonidine for outpatient opiate detoxification.

Condition or disease Intervention/treatment Phase
Heroin Dependence Morphine Dependence Substance Withdrawal Syndrome Drug: Buprenorphine/naloxone Phase 3

Detailed Description:
Patients randomized to the BUP/NX arm will receive daily doses for 13 days with sublingual administration of 2 mg buprenorphine/0.5 mg naloxone tablet(s) and/or an 8 mg buprenorphine/2.0 mg naloxone tablet(s). The starting dose on day 1 is 4 mg/1 mg BUP/NX with an additional 4 mg/1 mg, if needed, escalating in a step-wise manner to 16 mg/4 mg BUP/NX on day 3 and tapering to 2 mg/ 0.5 mg BUP/NX by days 12 to 13. Patients randomized to the clonidine arm will receive oral clonidine (0.05 to 0.1 mg depending upon weight) every 4 to 6 hours for 24 hours not to exceed 0.6 mg total on day 1. On day 2, a clonidine transdermal patch will be applied (0.1 mg/day/7-day patch with number of patches adjusted by weight). Oral clonidine will continue to be given on the second day of detoxification and increased to 0.2 mg every 6 hours or 0.1 mg every 3 hours not to exceed 0.8 mg over 24 hours. Patches will be worn all 13 days of detoxification. The dose of clonidine will be adjusted according to the proposed detoxification schedule, patient's weight, tolerance, and systolic blood pressure. Patients will receive counseling according to procedures in existence at each CTP throughout the study. Self-help detoxification handbooks will be distributed to all study participants.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 341 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Buprenorphine/Naloxone Versus Clonidine For Out-patient Opiate Detoxification
Study Start Date : January 2001
Actual Primary Completion Date : August 2002
Actual Study Completion Date : August 2002

Primary Outcome Measures :
  1. Drug use
  2. Degree of drug craving
  3. Opiate craving
  4. Adverse events
  5. Drug craving
  6. Decreased frequency of HIV related behavior
  7. Adverse effect measures

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Treatment-seeking males and non-pregnant and non-lactating females, 15 years and older, who fulfill DSM-IV criteria for opiate dependence, report experiencing symptoms of opiate withdrawal, are currently physically dependent on opioids and are in need of medical assistance for opioid withdrawal.
  2. Systolic blood pressure 100 mm Hg, and pulse 56 bpm.
  3. Good general health or, in case of a medical/psychiatric condition needing ongoing treatment, under the care of a physician willing to continue patient's medical management and cooperate with the study physicians.
  4. Agreeable to and capable of signing the informed consent approved by an institutional review board and, if under the age of 18 (excluding emancipated minors), assent and concurrent consent from a parent or legal guardian.
  5. Use of one of the following acceptable methods of birth control by female patients of childbearing potential:

    1. oral contraceptives
    2. barrier (diaphragm or cervical cap) with spermicide or condom
    3. intrauterine progesterone contraceptive system
    4. levonorgestrel implant
    5. medroxyprogesterone acetate contraceptive injection
    6. complete abstinence from sexual intercourse

Exclusion Criteria:

  1. Medical condition that would make participation, in the opinion of the study physician, medically hazardous (e.g., acute hepatitis, unstable cardiovascular, liver or renal disease);
  2. Clinically significant abnormalities in ECG.
  3. Known allergy or sensitivity to buprenorphine, naloxone, or clonidine.
  4. Receiving beta-blockers, calcium channel blockers, tricyclics, digitalis and other medications which may interact adversely with clonidine.
  5. Acute severe psychiatric condition in need of immediate treatment, or imminent suicide risk.
  6. Dependence on alcohol, benzodiazepines or other depressants, or stimulants, and requiring immediate medical attention.
  7. Participation in an investigational drug study, including buprenorphine, within the past 30 days.
  8. Methadone or LAAM maintenance or detoxification within 30 days of enrollment.
  9. Pending legal action that could prohibit or interfere with participation.
  10. Unable to remain in area for duration of active phase of treatment.
  11. Females that are pregnant, lactating, or planning to become pregnant.

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): NCT00032968

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United States, California
Haight-Ashbury Free Clinic
Berkeley, California, United States, 94704
Aegis Medical Systems, Inc.
Oxnard, California, United States, 93033
United States, Indiana
Midtown Community Mental Health Center
Indianapolis, Indiana, United States, 46202
United States, New Jersey
UMDNJ - Robert Wood Johnson Medical School
Piscataway, New Jersey, United States, 08854
United States, New York
Addiction Research and Treatment Corp
Brooklyn, New York, United States, 11201
New York, New York, United States, 10016
United States, Oregon
Kaiser Permanente Northwest, Division of Addiction
Portland, Oregon, United States, 97227
Sponsors and Collaborators
University of California, Los Angeles
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Principal Investigator: Walter Ling, M.D. Los Angeles Treatment Research Center

Additional Information:
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Responsible Party: Walter Ling, M.D., University of California, Los Angeles Identifier: NCT00032968    
Obsolete Identifiers: NCT00016757
Other Study ID Numbers: NIDA-CTN-0002-1
First Posted: April 8, 2002    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: April 2010
Keywords provided by National Institute on Drug Abuse (NIDA):
opiate dependence
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Heroin Dependence
Morphine Dependence
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Opioid-Related Disorders
Opiate Alkaloids
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action