Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification - 1

Last updated: January 11, 2017
Sponsor: University of California, Los Angeles
Overall Status: Completed

Phase

3

Condition

Opioid Use Disorder

Treatment

N/A

Clinical Study ID

NCT00032955
NIDA-CTN-0001-1
  • Ages > 15
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Treatment-seeking males and non-pregnant and non-lactating females, 15 years andolder, who fulfill DSM-IV criteria for opiate dependence, report experiencing symptomsof opiate withdrawal, are currently physically dependent on opioids, and are need ofmedical 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 ongoingtreatment, under the care of a physician willing to continue patient's medicalmanagement and cooperate with the study physicians.

  4. Agreeable to and capable of signing the informed consent approved by an institutionalreview board and, if under the age of 18 (excluding emancipated minors), assent andconcurrent consent from a parent or legal guardian.

  5. Use of one of the following acceptable methods of birth control by female patients ofchildbearing potential:

  6. oral contraceptives

  7. barrier (diaphragm or cervical cap) with spermicide or condom

  8. intrauterine progesterone contraceptive system

  9. levonorgestrel implant

  10. medroxyprogesterone acetate contraceptive injection

  11. complete abstinence from sexual intercourse

Exclusion

Exclusion Criteria:

  1. Medical condition that would make participation, in the opinion of the studyphysician, medically hazardous (e.g., acute hepatitis, unstable cardiovascular, liveror 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 othermedications which may interact adversely with clonidine.

  5. Acute severe psychiatric condition in need of immediate treatment, or imminent suiciderisk.

  6. Dependence on alcohol, benzodiazepines or other depressants, or stimulants, andrequiring immediate medical attention.

  7. Participation in an investigational drug study, including buprenorphine, within thepast 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.

Study Design

Total Participants: 163
Study Start date:
February 01, 2001
Estimated Completion Date:
August 31, 2002

Study 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.

Connect with a study center

  • Betty Ford Center

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • The Center For Drug-Free Living

    Orlando, Florida 32801
    United States

    Site Not Available

  • Operation PAR, Inc.

    Pinellas Park, Florida 33781
    United States

    Site Not Available

  • Self Help Addiction Rehabilitation (SHAR), Inc.

    Detroit, Michigan 48208
    United States

    Site Not Available

  • Phoenix House

    New York, New York 10023
    United States

    Site Not Available

  • Maryhaven, Inc.

    Columbus, Ohio 43207
    United States

    Site Not Available

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