Buprenorphine/Naloxone Versus Clonidine for Outpatient Opiate Detoxification - 1

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00032968
First received: April 5, 2002
Last updated: April 13, 2010
Last verified: April 2010

April 5, 2002
April 13, 2010
January 2001
August 2002   (final data collection date for primary outcome measure)
  • Drug use
  • Degree of drug craving
  • Opiate craving
  • Adverse events
  • Drug craving
  • Decreased frequency of HIV related behavior
  • Adverse effect measures
Same as current
Complete list of historical versions of study NCT00032968 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Buprenorphine/Naloxone Versus Clonidine for Outpatient Opiate Detoxification - 1
Buprenorphine/Naloxone Versus Clonidine For Out-patient Opiate Detoxification

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

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
  • Heroin Dependence
  • Morphine Dependence
  • Substance Withdrawal Syndrome
Drug: Buprenorphine/naloxone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
341
August 2002
August 2002   (final data collection date for primary outcome measure)

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.
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00032968
NIDA-CTN-0002-1
Yes
Walter Ling, M.D., University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: Walter Ling, M.D. Los Angeles Treatment Research Center
National Institute on Drug Abuse (NIDA)
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP