Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification - 1

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00032955
First received: April 5, 2002
Last updated: April 13, 2010
Last verified: April 2010
  Purpose

The purpose of this study is to assess buprenorphine/naloxone versus clonidine for inpatient opiate detoxification.


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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Drug use
  • Degree of drug craving
  • Adverse events
  • Drug craving
  • Decreased frequency of HIV related behavior
  • Adverse effect measures

Estimated Enrollment: 163
Study Start Date: February 2001
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 need of medical assistance for opioid withdrawal.
  2. Systolic blood pressure > or = 100mm Hg, and pulse > or = 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032955

Locations
United States, California
Betty Ford Center
Rancho Mirage, California, United States, 92270
United States, Florida
The Center For Drug-Free Living
Orlando, Florida, United States, 32801
Operation PAR, Inc.
Pinellas Park, Florida, United States, 33781
United States, Michigan
Self Help Addiction Rehabilitation (SHAR), Inc.
Detroit, Michigan, United States, 48208
United States, New York
Phoenix House
New York, New York, United States, 10023
United States, Ohio
Maryhaven, Inc.
Columbus, Ohio, United States, 43207
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Walter Ling, M.D. Los Angeles Treatment Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Walter Ling, M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00032955     History of Changes
Obsolete Identifiers: NCT00015392
Other Study ID Numbers: NIDA-CTN-0001-1
Study First Received: April 5, 2002
Last Updated: April 13, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Heroin Dependence
Morphine Dependence
Substance Withdrawal Syndrome
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Naloxone
Clonidine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 22, 2014