Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification - 1
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00032955|
Recruitment Status : Completed
First Posted : April 8, 2002
Last Update Posted : January 12, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Heroin Dependence Morphine Dependence Substance Withdrawal Syndrome||Drug: Buprenorphine/naloxone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||163 participants|
|Masking:||None (Open Label)|
|Official Title:||Buprenorphine/Naloxone Versus Clonidine for Inpatient Opiate Detoxification|
|Study Start Date :||February 2001|
|Actual Primary Completion Date :||August 2002|
|Actual Study Completion Date :||August 2002|
- Drug use
- Degree of drug craving
- Adverse events
- Drug craving
- Decreased frequency of HIV related behavior
- Adverse effect measures
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|Ages Eligible for Study:||15 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032955
|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|
|New York, New York, United States, 10023|
|United States, Ohio|
|Columbus, Ohio, United States, 43207|
|Principal Investigator:||Walter Ling, M.D.||Los Angeles Treatment Research Center|
|Responsible Party:||Walter Ling, M.D., University of California, Los Angeles|
|Other Study ID Numbers:||
|First Posted:||April 8, 2002 Key Record Dates|
|Last Update Posted:||January 12, 2017|
|Last Verified:||April 2010|
Substance Withdrawal Syndrome
Buprenorphine, Naloxone Drug Combination
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents