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Buprenorphine/Naloxone Versus Clonidine for Outpatient Opiate Detoxification - 1

Primary Purpose

Heroin Dependence, Morphine Dependence, Substance Withdrawal Syndrome

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine/naloxone
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heroin Dependence focused on measuring opiate dependence

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Systolic blood pressure 100 mm Hg, and pulse 56 bpm. 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. 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. Use of one of the following acceptable methods of birth control by female patients of childbearing potential: oral contraceptives barrier (diaphragm or cervical cap) with spermicide or condom intrauterine progesterone contraceptive system levonorgestrel implant medroxyprogesterone acetate contraceptive injection complete abstinence from sexual intercourse Exclusion Criteria: 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); Clinically significant abnormalities in ECG. Known allergy or sensitivity to buprenorphine, naloxone, or clonidine. Receiving beta-blockers, calcium channel blockers, tricyclics, digitalis and other medications which may interact adversely with clonidine. Acute severe psychiatric condition in need of immediate treatment, or imminent suicide risk. Dependence on alcohol, benzodiazepines or other depressants, or stimulants, and requiring immediate medical attention. Participation in an investigational drug study, including buprenorphine, within the past 30 days. Methadone or LAAM maintenance or detoxification within 30 days of enrollment. Pending legal action that could prohibit or interfere with participation. Unable to remain in area for duration of active phase of treatment. Females that are pregnant, lactating, or planning to become pregnant.

Sites / Locations

  • Haight-Ashbury Free Clinic
  • Aegis Medical Systems, Inc.
  • Midtown Community Mental Health Center
  • UMDNJ - Robert Wood Johnson Medical School
  • Addiction Research and Treatment Corp
  • Bellevue
  • Kaiser Permanente Northwest, Division of Addiction

Outcomes

Primary Outcome Measures

Drug use
Degree of drug craving
Opiate craving
Adverse events
Drug craving
Decreased frequency of HIV related behavior
Adverse effect measures

Secondary Outcome Measures

Full Information

First Posted
April 5, 2002
Last Updated
January 11, 2017
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00032968
Brief Title
Buprenorphine/Naloxone Versus Clonidine for Outpatient Opiate Detoxification - 1
Official Title
Buprenorphine/Naloxone Versus Clonidine For Out-patient Opiate Detoxification
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
August 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence, Morphine Dependence, Substance Withdrawal Syndrome
Keywords
opiate dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
341 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Buprenorphine/naloxone
Primary Outcome Measure Information:
Title
Drug use
Title
Degree of drug craving
Title
Opiate craving
Title
Adverse events
Title
Drug craving
Title
Decreased frequency of HIV related behavior
Title
Adverse effect measures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Systolic blood pressure 100 mm Hg, and pulse 56 bpm. 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. 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. Use of one of the following acceptable methods of birth control by female patients of childbearing potential: oral contraceptives barrier (diaphragm or cervical cap) with spermicide or condom intrauterine progesterone contraceptive system levonorgestrel implant medroxyprogesterone acetate contraceptive injection complete abstinence from sexual intercourse Exclusion Criteria: 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); Clinically significant abnormalities in ECG. Known allergy or sensitivity to buprenorphine, naloxone, or clonidine. Receiving beta-blockers, calcium channel blockers, tricyclics, digitalis and other medications which may interact adversely with clonidine. Acute severe psychiatric condition in need of immediate treatment, or imminent suicide risk. Dependence on alcohol, benzodiazepines or other depressants, or stimulants, and requiring immediate medical attention. Participation in an investigational drug study, including buprenorphine, within the past 30 days. Methadone or LAAM maintenance or detoxification within 30 days of enrollment. Pending legal action that could prohibit or interfere with participation. Unable to remain in area for duration of active phase of treatment. Females that are pregnant, lactating, or planning to become pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Ling, M.D.
Organizational Affiliation
Los Angeles Treatment Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haight-Ashbury Free Clinic
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Aegis Medical Systems, Inc.
City
Oxnard
State/Province
California
ZIP/Postal Code
93033
Country
United States
Facility Name
Midtown Community Mental Health Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson Medical School
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Facility Name
Addiction Research and Treatment Corp
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Bellevue
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Kaiser Permanente Northwest, Division of Addiction
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States

12. IPD Sharing Statement

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Buprenorphine/Naloxone Versus Clonidine for Outpatient Opiate Detoxification - 1

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