- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00032955
Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification - 1
January 11, 2017 updated by: University of California, Los Angeles
Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification
The purpose of this study is to assess buprenorphine/naloxone versus clonidine for inpatient opiate detoxification.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
163
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Rancho Mirage, California, United States, 92270
- Betty Ford Center
-
-
Florida
-
Orlando, Florida, United States, 32801
- The Center For Drug-Free Living
-
Pinellas Park, Florida, United States, 33781
- Operation PAR, Inc.
-
-
Michigan
-
Detroit, Michigan, United States, 48208
- Self Help Addiction Rehabilitation (SHAR), Inc.
-
-
New York
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New York, New York, United States, 10023
- Phoenix House
-
-
Ohio
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Columbus, Ohio, United States, 43207
- Maryhaven, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 need of medical assistance for opioid withdrawal.
- Systolic blood pressure > or = 100mm Hg, and pulse > or = 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Adverse events
|
Drug use
|
Degree of drug craving
|
Adverse effect measures
|
Drug craving
|
Decreased frequency of HIV related behavior
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Walter Ling, M.D., Los Angeles Treatment Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2001
Primary Completion (ACTUAL)
August 1, 2002
Study Completion (ACTUAL)
August 1, 2002
Study Registration Dates
First Submitted
April 5, 2002
First Submitted That Met QC Criteria
April 5, 2002
First Posted (ESTIMATE)
April 8, 2002
Study Record Updates
Last Update Posted (ESTIMATE)
January 12, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Heroin Dependence
- Substance Withdrawal Syndrome
- Morphine Dependence
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Buprenorphine
- Naloxone
- Buprenorphine, Naloxone Drug Combination
Other Study ID Numbers
- NIDA-CTN-0001-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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